[Federal Register Volume 62, Number 56 (Monday, March 24, 1997)]
[Rules and Regulations]
[Pages 13938-13970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7036]



[[Page 13937]]

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Part II





Department of Justice





_______________________________________________________________________



Drug Enforcement Administration



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21 CFR Part 1300, et al.



Consolidation, Elimination, and Clarification of Various Regulations; 
Final Rule

Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules 
and Regulations

[[Page 13938]]



DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1307, 1308, 
1309, 1310, 1311, 1312, 1313, and 1316

[DEA Number 139F]
RIN NUMBER 1117-AA33


Consolidation, Elimination, and Clarification of Various 
Regulations

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule is issued by the Acting Deputy Administrator 
of the Drug Enforcement Administration to institute the proposed 
changes to Title 21, Code of Federal Regulations, Parts 1300 through 
1316, published in the Federal Register on March 5, 1996 (61 FR 8503). 
In concert with the President's National Performance Review, Regulatory 
Reinvention Initiative (NPR), DEA proposed to consolidate, eliminate, 
and clarify many of its regulations; to address areas of confusion 
frequently raised by the pharmaceutical, chemical, and health care 
industries; and to correct inaccurate citations, office designations, 
and typographical errors.

EFFECTIVE DATE: March 28, 1997.

FOR FURTHER INFORMATION CONTACT: G. Thomas Gitchel, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, D.C. 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION: On March 5, 1996, DEA published in the 
Federal Register a notice of proposed rule making (NPRM) entitled 
Consolidation, Elimination, and Clarification of Various Regulations 
(61 FR 8503). This NPRM was the culmination of a comprehensive review 
of Title 21, Code of Federal Regulations (21 CFR), parts 1300 through 
1316. Title 21 contains the rules and regulations by which DEA 
implements the Controlled Substances Act, the Narcotic Addict Treatment 
Act, the Controlled Substances Import/Export Act, the Chemical 
Diversion and Trafficking Act, and the Domestic Chemical Diversion 
Control Act. DEA undertook this review to update, simplify, and 
consolidate its regulations in concert with the President's Regulatory 
Reform Initiative under the NPR; to clarify areas of confusion which 
have been raised by the pharmaceutical, chemical, and health care 
industries; and to correct inaccurate citations, office designations, 
and typographical errors. In so doing it was DEA's intention to reduce 
some of the regulatory burden on the affected industries. Interested 
parties were given 120 days to submit written comments regarding the 
proposed rule.

Comments

    Twenty-five organizations submitted comments in response to the 
proposed rule. One organization expressed support for the entire 
proposed rule as published, two others expressed support for one 
specific element within the proposal with no further substantive 
comment, and six others expressed their support for the comments 
submitted by their industry trade group. These and the comments of the 
other sixteen respondents are addressed below.

Part 1300

    Two commentors expressed their support for the consolidation of the 
definitions in new Secs. 1300.01 and 1300.02. One commentor suggested 
that the definition of ``home infusion pharmacy'' be deleted as 
unnecessary because all retail pharmacies are qualified to provide home 
infusion services, and the expression ``compounds for intramuscular 
infusion'' is confusing since the commentor was unaware of any pharmacy 
which actually compounds, as opposed to dispenses, intramuscular 
infusion solutions. DEA agrees that a definition of home infusion 
pharmacy is unnecessary as the distinction between home infusion 
services and other dispensing activities is adequately addressed within 
Sec. 1306.11(e), which permits the retention of faxed Schedule II 
prescriptions as original documents for home infusion prescriptions. 
Therefore, the definition of home infusion pharmacy will be removed 
from Sec. 1300.01 and the words ``home infusion pharmacy'' in 
Sec. 1306.11(e) will be replaced by the word ``pharmacy.'' When the 
original rule was published, DEA determined that there were in fact 
pharmacies which compound solutions for intramuscular injection. Even 
if this activity is no longer being performed by pharmacies, keeping 
this phrase in the definition allows for the possibility that in the 
future such activities may again be conducted.
    One commentor recommended that the definition of ``inventory'' be 
modified to include the terms ``bulk active drug substance, in-process 
materials (work in progress), and finished dosage form inventory.'' 
This definition, which was previously contained in part 1303, was not 
changed as part of this proposed rule and will, therefore, remain 
unchanged in the Final Rule. However, due to this comment and other 
questions previously raised by industry, a new definition of 
``inventory'' will be published for comment in the near future.
    One commentor expressed the opinion that the definitions of 
``hearing'', ``interested person'', and ``proceeding'' are unclear with 
respect to proceedings pursuant to 21 U.S.C. 952; that a definition of 
research be added which is in accordance with DEA's Policy Statement on 
Coincident Activities of Researchers, 60 FR 55310 (10/31/95); that the 
definitions which are repeated in Secs. 1300.01 and 1300.02 be removed 
from one of the sections; and that the references to ``this section'' 
in Sec. 1300.02(b)(12) and to ``this part'' in 
Sec. 1300.02(b)(28)(i)(B) are unclear. DEA does not agree that the 
definitions of ``hearing'', ``interested person'', and ``proceeding'' 
are not sufficiently clear. These definitions were not changed as part 
of the proposal and are sufficiently precise to fulfill their intended 
purpose.
    Since the only ambiguity regarding the term ``research'' addressed 
in the cited Policy Statement related to whether certain manufacturing 
activities may be conducted as coincident activities of a researcher 
registration or require a manufacturer registration, a statement 
consistent with the espoused policy will be added to the table of 
coincident activities, Sec. 1301.13(e)(1)(v), noting that dosage form 
development is not an authorized coincident activity of a researcher 
registration.
    The purpose of providing two sets of definitions, one for 
controlled substance handlers and one for chemical handlers, was to 
direct an interested person to a single source for all definitions 
relevant to that person's business activity. Therefore, it was deemed 
more appropriate and less confusing to repeat those few definitions 
which are common to both groups rather than to compel each person to 
identify which definitions pertain to them. The reference to ``this 
section'' in Sec. 1300.02(b)(12) will be replaced with the phrase ``for 
purposes of this definition'' and the reference to ``this part'' in 
Sec. 1300.02(b)(28)(i)(B) will be changed to reflect the part to which 
it refers, i.e. part 1310.

Part 1301

    Two commentors expressed support for the proposed change to 
Sec. 1301.21, Exemptions to Registrations and Fees. Another commentor 
expressed support for the proposal to extend the renewal period for 
bulk manufacturers to 120 days contained in Sec. 1301.13. One commentor 
stated that references to the

[[Page 13939]]

``Secretary'' in Sec. 1301.32 are unclear; the reference to ``these 
substances'' in Sec. 1301.34(b)(3) should be clarified; the reference 
to ``hearing'' in Sec. 1301.35(b) could be misinterpreted as referring 
to third-party hearings and recommended that the phrase ``in response 
to a show cause order'' be added; Sec. 1301.42 should reference the 
possibility that the hearing could involve the granting of any 
application for registration to import by adding the phrase ``to import 
or'' after the words ``for registration''; and Sec. 1301.46 should be 
clarified to indicate that if an application for registration to import 
a Schedule I or II substance is granted, the order should include an 
explanation of the basis for such granting by adding the phrase ``to 
import or'' after the words ``for registration''. The references in 
Sec. 1301.32 will be changed to identify the individual in question as 
the Secretary of Health and Human Services; the term ``these 
substances'' comes directly from the applicable statute and, therefore, 
cannot be changed by regulation; the phrase ``in response to a show 
cause order'' will be added to Sec. 1301.35(b); and the phrase ``to 
import or'' will be added to Secs. 1301.42 and 1301.46.

Part 1304

    Two comments were received supporting the acceptability of filing 
Schedule III-V prescriptions without marking them with a red ``C'' if 
the pharmacy can retrieve certain information with its data processing 
system as required by Sec. 1304.04(h)(2). One commentor recommended 
that the sentence ``Registrants who desire to continue maintaining 
central records will make notification to the local Special Agent in 
Charge as provided in paragraph (a) of this section'' be removed from 
Sec. 1304.04(e). This sentence was in fact removed in the proposed 
rule.
    Two commentors supported the change to Sec. 1304.11(c) which allows 
a registrant to conduct its biennial inventory on any date within two 
years from the date of its previous biennial inventory. One of these 
commentors noted that the proposed regulatory language implementing the 
proposed rule had not changed. The corrected language was published in 
the Federal Register on March 21, 1996 (61 FR 11594). One commentor 
suggested that the requirements of Sec. 1304.11(e)(3)(ii) were 
misstated. The commentor believed that DEA was intending to require 
dispensers and researchers to make an exact inventory count of Schedule 
III-V drugs in opened containers when the containers held fewer than 
1,000 tablets or capsules, and an estimate if the containers held more 
than 1,000. The language in the proposed rule, which is unchanged from 
the existing regulation, is correct as stated in the proposed rule.
    Two comments were received which recommended that the terms 
``receipt'' and ``distribution'' contained in Secs. 1304.22(a)(2)(iv) 
and 1304.22(a)(2)(vii) be changed to ``acquisition to inventory'' and 
``reduction from inventory'' for purposes of clarity and consistency 
with the terms used for ARCOS reporting. The recommended terms will be 
incorporated into those sections.
    Four commentors expressed their support for the change to 
Sec. 1304.33 which puts ARCOS reporting on a quarterly rather than a 
monthly schedule. One commentor recommended that Sec. 1304.33(b) be 
modified to specify that controlled substances in the various stages of 
production be included in the year-end ARCOS inventory. The language in 
the current regulation indicating that registrants should identify 
whether each reported substance is in storage or in process of 
manufacturing was inadvertently omitted and will be reinstated. The 
final rule will also be amended to permit quarterly reporting, as well 
as annual reporting, of manufacturing transactions if the reporting 
registrant so chooses.

Part 1305

    One commentor objected to the removal of the information from the 
regulations which is contained on the back of DEA-222 Order Forms, as 
this information might be needed at a training site which is a non-
registered location and, therefore, would be unavailable for reference 
purposes. When needed for training or other off-site purposes, the 
backs of the order forms containing the requisite information could be 
photocopied and provided to students at least as easily as providing 
copies of the CFR. Therefore, the information will be deleted as 
originally proposed.
    One commentor suggested that the phrase used in Sec. 1305.06(b), 
``last line completed,'' was inconsistent with the recently changed 
term used on the DEA-222 Order Forms themselves. The commentor is 
correct. The phrase used on the Order Forms, ``No. of lines 
completed,'' was adopted recently for purposes of clarity and has been 
substituted in the final rule for the language contained in the 
proposed rule. Another commentor recommended that Sec. 1305.06(b) be 
modified to acknowledge that some substances may require more than one 
line to fully describe the substance being ordered. DEA believes that 
the amount of space provided on a single line is generally sufficient 
to completely identify the controlled substance. This same commentor 
recommended that Sec. 1305.09(e) be amended to explain that an item on 
an Order Form can be partially filled with less but not more than the 
quantity ordered. The paragraph in question states that a purchaser 
must record the date and quantity of the items received on copy 3 of 
the Order Form. The statement being recommended for inclusion in 
paragraph (e) is clearly and appropriately contained in paragraph (b) 
of this section which relates to what can be supplied. This commentor 
also recommended that Sec. 1305.11(a)(1) be modified to explain when an 
Order Form is not ``complete.'' DEA believes that the term ``complete'' 
is self-explanatory, i.e. the purchaser must enter all the information 
called for in the spaces provided except those that specifically state 
that the information is to be filled in by the supplier.

Part 1306

    Five commentors expressed support for the extension of time to 7 
days from 72 hours within which pharmacies must obtain written 
prescriptions to cover emergency oral prescriptions for Schedule II 
controlled substances, as required by Sec. 1306.11(d)(4).
    Five comments were received regarding the proposal to allow 
pharmacies to retain faxed Schedule II prescription records as original 
documents for patients in a home hospice setting. One commentor 
supported the change without further elaboration. A second commentor 
recommended that the terms ``terminal illness'' or ``terminally ill'' 
be substituted for the word ``hospice,'' so as to make the rule less 
restrictive; if the terms hospice or home hospice were retained, it was 
recommended that they be defined. The last three commentors suggested 
that the rule be changed to allow pharmacies to accept faxed Schedule 
II prescriptions for individuals in all hospice settings, not just 
individuals in home hospice settings who have been released from 
registered institutions and are receiving daily skilled nursing care. 
It was suggested by two of these commentors that this would be best 
achieved by replacing the relevant language in the proposed rule with 
the phrase: ``a hospice certified by Medicare under Title XVIII or 
licensed by the state.'' As stated in the proposed rule, it was DEA's 
intention to allow faxed Schedule II prescriptions to be retained as 
original documents in order

[[Page 13940]]

to ease the recordkeeping burden for physicians and pharmacies for non-
institutionalized patients who require frequent and/or unanticipated 
changes in their Schedule II narcotic medication. It was DEA's belief 
that individuals residing in a hospice facility licensed by the state 
would already be covered by the existing exception to the rule afforded 
to patients residing in Long Term Care Facilities. This proposal was 
directed at individuals who require a similar level of care but reside 
at home rather than in an institution. However, based on the comments 
received and to insure that no properly affected individuals will be 
inadvertently excluded from the exception, the recommended phrase, ``a 
hospice certified by Medicare under Title XVIII or licensed by the 
state,'' will be incorporated into the final rule.
    Two commentors expressed support for the removal of the 
requirement, previously contained in Sec. 1306.13(b), that a pharmacist 
determine that subsequent partial fillings of Schedule II prescriptions 
for patients in Long Term Care Facilities are still necessary. One 
commentor pointed out that a sentence was needlessly repeated in this 
paragraph; one of which will be removed.
    Two commentors voiced their support for the proposal to permit 
Schedule III-V prescription information to be transferred for refill 
purposes up to the maximum number of times authorized by the physician 
among pharmacies sharing a real-time, on-line electronic database.

Part 1308

    One commentor disagreed with the proposal to remove the tables of 
exempted and excluded products from Secs. 1308.24, 1308.26, 1308.32, 
and 1308.34. This commentor expressed concern that by removing the 
tables, DEA would not be obligated to publish changes to the tables as 
they occur, thus denying interested parties an opportunity to comment 
and/or adapt operations as needed. The requirement to publish all 
approvals of exempted and excluded products in the Federal Register in 
order to allow an opportunity for comment remains unchanged in the 
following sections: 1308.23(e), 1308.25(c), 1308.31(c), and 1308.33(d). 
The tables will continue to be published for comment in the Federal 
Register each year. Therefore, the proposal to remove these tables will 
have no effect on the ability of interested parties to comment and/or 
adapt their operations. Another commentor suggested that the rule be 
modified to require DEA to provide state scheduling authorities which 
do not receive the Federal Register separate notification of changes to 
the lists of exempted and excluded products. States which do not 
receive copies of the Federal Register directly can request updated 
lists from the local DEA office or from DEA Headquarters.

Part 1316

    Four commentors expressed support for the change to Sec. 1316.13 
which replaces the present schedule of administrative inspections with 
a system whereby the frequency of inspections will be determined by 
factors such as the prior history of the registrant, the potential for 
diversion, and the existence of pharmaceutical controlled substances 
found in the illicit market. Three of these commentors suggested adding 
a requirement that an exit interview be conducted at the completion of 
the investigation. Although it is DEA policy to conduct an exit 
interview, there are occasions when it would be premature and/or 
inadvisable to discuss results at the completion of the on-site portion 
of the investigation. Therefore, DEA declines to add such a 
requirement.
    In the proposed rule the table of registration categories under 
Sec. 1301.13(e)(1)(iv) incorrectly included instructing as an 
authorized activity with Schedule I substances. The words ``or 
Instructing'' are being removed in the Final Rule. In the proposed rule 
Sec. 1304.22(c) should have included a reference to paragraph 
(a)(2)(vii) of this section which will be inserted in the Final Rule. 
In the proposed rule the authority citation for subpart A of part 1316 
omitted Section ``830(a)'' of 21 U.S.C. inadvertently. It is being 
reinstated in the Final Rule. A typographical error in Sec. 1316.12 
which was overlooked for correction in the proposed rule is being 
corrected in the Final Rule; the reference should read ``21 U.S.C. 
842(a)(6)'' not ``21 U.S.C. (a)(6).''
    In addition to the comments previously discussed, several 
commentors also identified typographical errors in the proposed rule 
which will be corrected in the final rule.
    Five of the commentors took this occasion to recommend that DEA 
adopt new regulations and procedures in a number of areas that go 
beyond what was published in the proposed rule. A number of these are 
matters of internal procedures which do not require regulatory changes 
and are under development and discussion with the commentors, e.g. 
batch certification and renewal of applications. Several 
recommendations addressed issues which were not part of this rulemaking 
and since other interested parties have not been given an opportunity 
to comment on them, were not considered, e.g. permitting pharmacies to 
receive controlled substances from LTCFs for disposal purposes, 
requiring hospitals to provide suffix information for affiliated 
practitioners, adding an Affidavit for Power of Attorney to allow 
pharmacies to be operated by an acquirer under the existing 
registration pending approval of the new application.
    Several commentors recommended that the regulations be changed to 
permit registered distributors to utilize cross-docking/freight-
forwarding facilities. Although this was not part of the proposed rule, 
on December 18, 1996, DEA published a proposed rule to permit such 
activities. Still other commentors proposed changes which would modify 
specific requirements mandated by law and, therefore, cannot be altered 
by regulation, e.g. written prescriptions for Schedule II controlled 
substances. As was stated in the proposed rule, DEA is committed to 
constant self-examination, responsiveness to technological innovation, 
and working with industry to develop effective and minimally intrusive 
methods of preventing and detecting the diversion of controlled 
substances. The comments which suggested additional changes not 
proposed as part of this NPRM will be evaluated and, where appropriate, 
addressed in future meetings and conferences with the regulated 
industry.
    The Acting Deputy Administrator, in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 605(b)) as amended by the Small Business 
Regulatory Enforcement Act of 1996 (Pub. L. 104-121), has reviewed this 
final rule and based on the supplemental information above certifies 
that this rulemaking will not have a significant economic impact on a 
substantial number of small entities. This final rule imposes no 
additional regulatory burdens on small businesses. To the contrary, it 
is primarily intended to streamline and simplify various regulations in 
order to provide regulatory relief to registrants. Various regulations 
and reports were either eliminated or reduced to allow greater 
flexibility in complying with existing requirements. For example, the 
frequency of reports to ARCOS were reduced to quarterly from monthly; 
some pharmacies will be permitted to transfer prescription information 
for refill purposes more frequently; all pharmacies will be permitted 
to retain faxed prescriptions as original

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documents for hospice patients; pharmacies will no longer be required 
to determine if additional partial fillings of prescriptions are 
necessary for patients in LTCFs; and all registrants will be given the 
flexibility to establish the date for their biennial inventory.
    This rulemaking has been drafted in accordance with Executive Order 
12866, section 1(b), Principles of Regulation. The Office of Management 
and Budget has reviewed this final rule and determined that it is not a 
``significant regulatory action'' under Executive Order 12866, section 
3(f), Regulatory Planning and Review.
    This regulation will not have substantial direct effects on the 
States, on the relationship between the national government and the 
States, or on distribution of power and responsibilities among the 
various levels of government. Therefore, in accordance with Executive 
Order 12612, it is determined that this final rule does not have 
sufficient federalism implications to warrant the preparation of a 
Federalism Assessment.

List of Subjects in 21 CFR Parts 1300-1316

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Labeling, List I and List II chemicals, Narcotics, 
Packaging and containers, Prescription drugs, Reporting requirements, 
Research, Security measures, Seizures and forfeitures.
    For the reasons stated in the preamble, 21 CFR Ch. II is amended as 
follows:
    21 CFR part 1300 is added to read as follows:

PART 1300--DEFINITIONS

Sec.
1300.01  Definitions relating to controlled substances.
1300.02  Definitions relating to listed chemicals.

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f)

Sec. 1300.01  Definitions relating to controlled substances.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1301 through 1308 and part 1312 of this 
chapter, the following terms shall have the meanings specified:
    (1) The term Act means the Controlled Substances Act, as amended 
(84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import 
and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951).
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The term anabolic steroid means any drug or hormonal substance, 
chemically and pharmacologically related to testosterone (other than 
estrogens, progestins, and corticosteroids) that promotes muscle 
growth, and includes:
    (i) Boldenone;
    (ii) Chlorotestosterone (4-chlortestosterone);
    (iii) Clostebol;
    (iv) Dehydrochlormethyltestosterone;
    (v) Dihydrotestosterone (4-dihydrotestosterone);
    (vi) Drostanolone;
    (vii) Ethylestrenol;
    (viii) Fluoxymesterone;
    (ix) Formebulone (formebolone);
    (x) Mesterolone;
    (xi) Methandienone;
    (xii) Methandranone;
    (xiii) Methandriol;
    (xiv) Methandrostenolone;
    (xv) Methenolone;
    (xvi) Methyltestosterone;
    (xvii) Mibolerone;
    (xviii) Nandrolone;
    (xix) Norethandrolone;
    (xx) Oxandrolone;
    (xxi) Oxymesterone;
    (xxii) Oxymetholone;
    (xxiii) Stanolone;
    (xxiv) Stanozolol;
    (xxv) Testolactone;
    (xxvi) Testosterone;
    (xxvii) Trenbolone; and
    (xxviii) Any salt, ester, or isomer of a drug or substance 
described or listed in this paragraph, if that salt, ester, or isomer 
promotes muscle growth. Except such term does not include an anabolic 
steroid which is expressly intended for administration through implants 
to cattle or other nonhuman species and which has been approved by the 
Secretary of Health and Human Services for such administration. If any 
person prescribes, dispenses, or distributes such steroid for human 
use, such person shall be considered to have prescribed, dispensed, or 
distributed an anabolic steroid within the meaning of this paragraph.
    (5) The term basic class means, as to controlled substances listed 
in Schedules I and II:
    (i) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.11(b) of this 
chapter;
    (ii) Each of the opium derivatives, including its salts, isomers, 
and salts of isomers whenever the existence of such salts, isomers, and 
salts of isomers is possible within the specific chemical designation, 
listed in Sec. 1308.11(c) of this chapter;
    (iii) Each of the hallucinogenic substances, including its salts, 
isomers, and salts of isomers whenever the existence of such salts, 
isomers, and salts of isomers is possible within the specific chemical 
designation, listed in Sec. 1308.11(d) of this chapter;
    (iv) Each of the following substances, whether produced directly or 
indirectly by extraction from substances of vegetable origin, or 
independently by means of chemical synthesis, or by a combination of 
extraction and chemical synthesis:
    (A) Opium, including raw opium, opium extracts, opium fluid 
extracts, powdered opium, granulated opium, deodorized opium and 
tincture of opium;
    (B) Apomorphine;
    (C) Codeine;
    (D) Etorphine hydrochloride;
    (E) Ethylmorphine;
    (F) Hydrocodone;
    (G) Hydromorphone;
    (H) Metopon;
    (I) Morphine;
    (J) Oxycodone;
    (K) Oxymorphone;
    (L) Thebaine;
    (M) Mixed alkaloids of opium listed in Section 1308.12(b)(2) of 
this chapter;
    (N) Cocaine; and
    (O) Ecgonine;
    (v) Each of the opiates, including its isomers, esters, ethers, 
salts, and salts of isomers, esters, and ethers whenever the existence 
of such isomers, esters, ethers, and salts is possible within the 
specific chemical designation, listed in Sec. 1308.12(c) of this 
chapter; and
    (vi) Methamphetamine, its salts, isomers, and salts of its isomers;
    (vii) Amphetamine, its salts, optical isomers, and salts of its 
optical isomers;
    (viii) Phenmetrazine and its salts;
    (ix) Methylphenidate;
    (x) Each of the substances having a depressant effect on the 
central nervous system, including its salts, isomers, and salts of 
isomers whenever the existence of such salts, isomers, and salts of 
isomers is possible within the specific chemical designation, listed in 
Sec. 1308.12(e) of this chapter.
    (6) The term commercial container means any bottle, jar, tube, 
ampule, or other receptacle in which a substance is

[[Page 13942]]

held for distribution or dispensing to an ultimate user, and in 
addition, any box or package in which the receptacle is held for 
distribution or dispensing to an ultimate user. The term commercial 
container does not include any package liner, package insert or other 
material kept with or within a commercial container, nor any carton, 
crate, drum, or other package in which commercial containers are stored 
or are used for shipment of controlled substances.
    (7) The term compounder means any person engaging in maintenance or 
detoxification treatment who also mixes, prepares, packages or changes 
the dosage form of a narcotic drug listed in Schedules II, III, IV or V 
for use in maintenance or detoxification treatment by another narcotic 
treatment program.
    (8) The term controlled substance has the meaning given in section 
802(6) of Title 21, United States Code (U.S.C.).
    (9) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.
    (10) The term detoxification treatment means the dispensing, for a 
period of time as specified below, of a narcotic drug or narcotic drugs 
in decreasing doses to an individual to alleviate adverse physiological 
or psychological effects incident to withdrawal from the continuous or 
sustained use of a narcotic drug and as a method of bringing the 
individual to a narcotic drug-free state within such period of time. 
There are two types of detoxification treatment: Short-term 
detoxification treatment and long-term detoxification treatment.
    (i) Short-term detoxification treatment is for a period not in 
excess of 30 days.
    (ii) Long-term detoxification treatment is for a period more than 
30 days but not in excess of 180 days.
    (11) The term dispenser means an individual practitioner, 
institutional practitioner, pharmacy or pharmacist who dispenses a 
controlled substance.
    (12) The term export means, with respect to any article, any taking 
out or removal of such article from the jurisdiction of the United 
States (whether or not such taking out or removal constitutes an 
exportation within the meaning of the customs and related laws of the 
United States).
    (13) The term exporter includes every person who exports, or who 
acts as an export broker for exportation of, controlled substances 
listed in any schedule.
    (14) The term hearing means:
    (i) In part 1301 of this chapter, any hearing held for the 
granting, denial, revocation, or suspension of a registration pursuant 
to sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (ii) In part 1303 of this chapter, any hearing held regarding the 
determination of aggregate production quota or the issuance, 
adjustment, suspension, or denial of a procurement quota or an 
individual manufacturing quota.
    (iii) In part 1308 of this chapter, any hearing held for the 
issuance, amendment, or repeal of any rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (15) The term import means, with respect to any article, any 
bringing in or introduction of such article into either the 
jurisdiction of the United States or the customs territory of the 
United States, and from the jurisdiction of the United States into the 
customs territory of the United States (whether or not such bringing in 
or introduction constitutes an importation within the meaning of the 
tariff laws of the United States).
    (16) The term importer includes every person who imports, or who 
acts as an import broker for importation of, controlled substances 
listed in any schedule.
    (17) The term individual practitioner means a physician, dentist, 
veterinarian, or other individual licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he/she 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacist, a pharmacy, 
or an institutional practitioner.
    (18) The term institutional practitioner means a hospital or other 
person (other than an individual) licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which it 
practices, to dispense a controlled substance in the course of 
professional practice, but does not include a pharmacy.
    (19) The term interested person means any person adversely affected 
or aggrieved by any rule or proposed rule issuable pursuant to section 
201 of the Act (21 U.S.C. 811).
    (20) The term inventory means all factory and branch stocks in 
finished form of a basic class of controlled substance manufactured or 
otherwise acquired by a registrant, whether in bulk, commercial 
containers, or contained in pharmaceutical preparations in the 
possession of the registrant (including stocks held by the registrant 
under separate registration as a manufacturer, importer, exporter, or 
distributor).
    (21) The term isomer means the optical isomer, except as used in 
Sec. 1308.11(d) and Sec. 1308.12(b)(4) of this chapter. As used in 
Sec. 1308.11(d) of this chapter, the term isomer means the optical, 
positional, or geometric isomer. As used in Sec. 1308.12(b)(4) of this 
chapter, the term isomer means the optical or geometric isomer.
    (22) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (23) The term label means any display of written, printed, or 
graphic matter placed upon the commercial container of any controlled 
substance by any manufacturer of such substance.
    (24) The term labeling means all labels and other written, printed, 
or graphic matter:
    (i) Upon any controlled substance or any of its commercial 
containers or wrappers, or
    (ii) Accompanying such controlled substance.
    (25) The term Long Term Care Facility (LTCF) means a nursing home, 
retirement care, mental care or other facility or institution which 
provides extended health care to resident patients.
    (26) The term maintenance treatment means the dispensing for a 
period in excess of twenty-one days, of a narcotic drug or narcotic 
drugs in the treatment of an individual for dependence upon heroin or 
other morphine-like drug.
    (27) The term manufacture means the producing, preparation, 
propagation, compounding, or processing of a drug or other substance or 
the packaging or repackaging of such substance, or the labeling or 
relabeling of the commercial container of such substance, but does not 
include the activities of a practitioner who, as an incident to his/her 
administration or dispensing such substance in the course of his/her 
professional practice, prepares, compounds, packages or labels such 
substance. The term manufacturer means a person who manufactures a drug 
or other substance, whether under a registration as a manufacturer or 
under authority of registration as a researcher or chemical analyst.
    (28) The term mid-level practitioner means an individual 
practitioner, other than a physician, dentist, veterinarian, or 
podiatrist, who is licensed, registered, or otherwise permitted by the 
United States or the jurisdiction in which he/she practices, to 
dispense a controlled substance in the course of professional practice. 
Examples of mid-level practitioners include, but are not limited to, 
health care providers such as nurse practitioners, nurse midwives,

[[Page 13943]]

nurse anesthetists, clinical nurse specialists and physician assistants 
who are authorized to dispense controlled substances by the state in 
which they practice.
    (29) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (30) The term narcotic drug means any of the following whether 
produced directly or indirectly by extraction from substances of 
vegetable origin or independently by means of chemical synthesis or by 
a combination of extraction and chemical synthesis:
    (i) Opium, opiates, derivatives of opium and opiates, including 
their isomers, esters, ethers, salts, and salts of isomers, esters, and 
ethers whenever the existence of such isomers, esters, ethers and salts 
is possible within the specific chemical designation. Such term does 
not include the isoquinoline alkaloids of opium.
    (ii) Poppy straw and concentrate of poppy straw.
    (iii) Coca leaves, except coca leaves and extracts of coca leaves 
from which cocaine, ecgonine and derivatives of ecgonine or their salts 
have been removed.
    (iv) Cocaine, its salts, optical and geometric isomers, and salts 
of isomers.
    (v) Ecgonine, its derivatives, their salts, isomers and salts of 
isomers.
    (vi) Any compound, mixture, or preparation which contains any 
quantity of any of the substances referred to in paragraphs (b)(31)(i) 
through (v) of this section.
    (31) The term narcotic treatment program means a program engaged in 
maintenance and/or detoxification treatment with narcotic drugs.
    (32) The term net disposal means, for a stated period, the quantity 
of a basic class of controlled substance distributed by the registrant 
to another person, plus the quantity of that basic class used by the 
registrant in the production of (or converted by the registrant into) 
another basic class of controlled substance or a noncontrolled 
substance, plus the quantity of that basic class otherwise disposed of 
by the registrant, less the quantity of that basic class returned to 
the registrant by any purchaser, and less the quantity of that basic 
class distributed by the registrant to another registered manufacturer 
of that basic class for purposes other than use in the production of, 
or conversion into, another basic class of controlled substance or a 
noncontrolled substance or in the manufacture of dosage forms of that 
basic class.
    (33) The term pharmacist means any pharmacist licensed by a State 
to dispense controlled substances, and shall include any other person 
(e.g., pharmacist intern) authorized by a State to dispense controlled 
substances under the supervision of a pharmacist licensed by such 
State.
    (34) The term person includes any individual, corporation, 
government or governmental subdivision or agency, business trust, 
partnership, association, or other legal entity.
    (35) The term prescription means an order for medication which is 
dispensed to or for an ultimate user but does not include an order for 
medication which is dispensed for immediate administration to the 
ultimate user. (e.g., an order to dispense a drug to a bed patient for 
immediate administration in a hospital is not a prescription.)
    (36) The term proceeding means all actions taken for the issuance, 
amendment, or repeal of any rule issued pursuant to section 201 of the 
Act (21 U.S.C. 811), commencing with the publication by the 
Administrator of the proposed rule, amended rule, or repeal in the 
Federal Register.
    (37) The term purchaser means any registered person entitled to 
obtain and execute order forms pursuant to Section 1305.04 and Section 
1305.06.
    (38) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or 
records are kept on which certain items are asterisked, redlined, or in 
some other manner visually identifiable apart from other items 
appearing on the records.
    (39) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 
823 or 957).
    (40) The term registrant means any person who is registered 
pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 
823 or 958).
    (41) The term supplier means any registered person entitled to fill 
order forms pursuant to Sec. 1305.08 of this chapter.


Sec. 1300.02  Definitions relating to listed chemicals.

    (a) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802), except that certain 
terms used in part 1316 of this chapter are defined at the beginning of 
each subpart of that part.
    (b) As used in parts 1309, 1310, and 1313 of this chapter, the 
following terms shall have the meaning specified:
    (1) The term Act means the Controlled Substances Act, as amended 
(84 Stat. 1242; 21 U.S.C. 801) and/or the Controlled Substances Import 
and Export Act, as amended (84 Stat. 1285; 21 U.S.C. 951) as amended.
    (2) The term Administration means the Drug Enforcement 
Administration.
    (3) The term Administrator means the Administrator of the Drug 
Enforcement Administration. The Administrator has been delegated 
authority under the Act by the Attorney General (28 CFR 0.100).
    (4) The terms broker and trader mean any individual, corporation, 
corporate division, partnership, association, or other legal entity 
which assists in arranging an international transaction in a listed 
chemical by--
    (i) Negotiating contracts;
    (ii) Serving as an agent or intermediary; or
    (iii) Fulfilling a formal obligation to complete the transaction by 
bringing together a buyer and seller, a buyer and transporter, or a 
seller and transporter, or by receiving any form of compensation for so 
doing.
    (5) The term chemical export means transferring ownership or 
control, or the sending or taking of threshold quantities of listed 
chemicals out of the United States (whether or not such sending or 
taking out constitutes an exportation within the meaning of the Customs 
and related laws of the United States).
    (6) The term chemical exporter is a regulated person who, as the 
principal party in interest in the export transaction, has the power 
and responsibility for determining and controlling the sending of the 
listed chemical out of the United States.
    (7) The term chemical import means with respect to a listed 
chemical, any bringing in or introduction of such listed chemical into 
either the jurisdiction of the United States or into the Customs 
territory of the United States (whether or not such bringing in or 
introduction constitutes an importation within the meaning of the 
tariff laws of the United States).
    (8) The term chemical importer is a regulated person who, as the 
principal party in interest in the import transaction, has the power 
and responsibility for determining and controlling the bringing in or 
introduction of the listed chemical into the United States.
    (9) The term chemical mixture means a combination of two or more 
chemical substances, at least one of which is not a listed chemical, 
except that such term does not include any combination of a listed 
chemical with another chemical that is present solely as an impurity or

[[Page 13944]]

which has been created to evade the requirements of the Act.
    (10) The term customs territory of the United States means the 
several States, the District of Columbia, and Puerto Rico.
    (11) The term encapsulating machine means any manual, semi-
automatic, or fully automatic equipment which may be used to fill 
shells or capsules with any powdered, granular, semi-solid, or liquid 
material.
    (12) The term established business relationship with a foreign 
customer means the regulated person has exported a listed chemical at 
least once within the past six months, or twice within the past twelve 
months to a foreign manufacturer, distributor, or end user of the 
chemical that has an established business in the foreign country with a 
fixed street address. A person or business which functions as a broker 
or intermediary is not a customer for purposes of this definition. The 
term also means that the regulated person has provided the 
Administration with the following information in accordance with the 
waiver of 15-day advance notice requirements of Sec. 1313.24 of this 
chapter:
    (i) The name and street address of the chemical exporter and of 
each regular customer;
    (ii) The telephone number, telex number, contact person, and where 
available, the facsimile number for the chemical exporter and for each 
regular customer;
    (iii) The nature of the regular customer's business (i.e., 
importer, exporter, distributor, manufacturer, etc.), and if known, the 
use to which the listed chemical or chemicals will be applied;
    (iv) The duration of the business relationship;
    (v) The frequency and number of transactions occurring during the 
preceding 12-month period;
    (vi) the amounts and the listed chemical or chemicals involved in 
regulated transactions between the chemical exporter and regular 
customer;
    (vii) The method of delivery (direct shipment or through a broker 
or forwarding agent); and
    (viii) Other information that the chemical exporter considers 
relevant for determining whether a customer is a regular customer.
    (13) The term established record as an importer means that the 
regulated person has imported a listed chemical at least once within 
the past six months, or twice within the past twelve months from a 
foreign supplier. The term also means that the regulated person has 
provided the Administration with the following information in 
accordance with the waiver of the 15-day advance notice requirements of 
Sec. 1313.15 of this chapter:
    (i) The name, DEA registration number (where applicable), street 
address, telephone number, telex number, and, where available, the 
facsimile number of the regulated person and of each foreign supplier; 
and
    (ii) The frequency and number of transactions occurring during the 
preceding 12 month period.
    (14) The term hearing means any hearing held for the granting, 
denial, revocation, or suspension of a registration pursuant to 
sections 303, 304, and 1008 of the Act (21 U.S.C. 823, 824 and 958).
    (15) The term international transaction means a transaction 
involving the shipment of a listed chemical across an international 
border (other than a United States border) in which a broker or trader 
located in the United States participates.
    (16) The term jurisdiction of the United States means the customs 
territory of the United States, the Virgin Islands, the Canal Zone, 
Guam, American Samoa, and the Trust Territories of the Pacific Islands.
    (17) The term listed chemical means any List I chemical or List II 
chemical.
    (18) The term List I chemical means a chemical specifically 
designated by the Administrator in Sec. 1310.02(a) of this chapter 
that, in addition to legitimate uses, is used in manufacturing a 
controlled substance in violation of the Act and is important to the 
manufacture of a controlled substance.
    (19) The term List II chemical means a chemical, other than a List 
I chemical, specifically designated by the Administrator in 
Sec. 1310.02(b) of this chapter that, in addition to legitimate uses, 
is used in manufacturing a controlled substance in violation of the 
Act.
    (20) The term name means the official name, common or usual name, 
chemical name, or brand name of a substance.
    (21) The term person includes any individual, corporation, 
government or governmental subdivision or agency, business trust, 
partnership, association, or other legal entity.
    (22) The term readily retrievable means that certain records are 
kept by automatic data processing systems or other electronic or 
mechanized recordkeeping systems in such a manner that they can be 
separated out from all other records in a reasonable time and/or 
records are kept on which certain items are asterisked, redlined, or in 
some other manner visually identifiable apart from other items 
appearing on the records.
    (23) The terms register and registration refer only to registration 
required and permitted by sections 303 or 1007 of the Act (21 U.S.C. 
823 or 957).
    (24) The term registrant means any person who is registered 
pursuant to either section 303 or section 1008 of the Act (21 U.S.C. 
823 or 958).
    (25) The term regular customer means a person with whom the 
regulated person has an established business relationship for a 
specified listed chemical or chemicals that has been reported to the 
Administration subject to the criteria established in 
Sec. 1300.02(b)(12).
    (26) The term regular importer means, with respect to a listed 
chemical, a person that has an established record as an importer of 
that listed chemical that is reported to the Administrator.
    (27) The term regulated person means any individual, corporation, 
partnership, association, or other legal entity who manufactures, 
distributes, imports, or exports a listed chemical, a tableting 
machine, or an encapsulating machine, or who acts as a broker or trader 
for an international transaction involving a listed chemical, tableting 
machine, or encapsulating machine.
    (28) The term regulated transaction means:
    (i) A distribution, receipt, sale, importation, or exportation of a 
listed chemical, or an international transaction involving shipment of 
a listed chemical, or if the Administrator establishes a threshold 
amount for a specific listed chemical, a threshold amount as determined 
by the Administrator, which includes a cumulative threshold amount for 
multiple transactions, of a listed chemical, except that such term does 
not include:
    (A) A domestic lawful distribution in the usual course of business 
between agents or employees of a single regulated person; in this 
context, agents or employees means individuals under the direct 
management and control of the regulated person;
    (B) A delivery of a listed chemical to or by a common or contract 
carrier for carriage in the lawful and usual course of the business of 
the common or contract carrier, or to or by a warehouseman for storage 
in the lawful and usual course of the business of the warehouseman, 
except that if the carriage or storage is in connection with the 
distribution, importation, or exportation of a listed chemical to a 
third person, this paragraph does not relieve a distributor, importer, 
or

[[Page 13945]]

exporter from compliance with parts 1309, 1310, and 1313 of this 
chapter;
    (C) Any category of transaction or any category of transaction for 
a specific listed chemical or chemicals specified by regulation of the 
Administrator as excluded from this definition as unnecessary for 
enforcement of the Act;
    (D) Any transaction in a listed chemical that is contained in a 
drug that may be marketed or distributed lawfully in the United States 
under the Federal Food, Drug, and Cosmetic Act unless--
    (1) the drug contains ephedrine or its salts, optical isomers, or 
salts of optical isomers as the only active medicinal ingredient or 
contains ephedrine or its salts, optical isomers or salts of optical 
isomers and therapeutically insignificant quantities of another active 
medicinal ingredient. For purposes of this paragraph, the term 
``therapeutically insignificant quantities'' shall apply if the product 
formulation (i.e., the qualitative and quantitative composition of 
active ingredients within the product) is not listed in any of the 
following compendiums: American Pharmaceutical Association (Apha) 
Handbook of Nonprescription Drugs; Drug Facts and Comparisons 
(published by Wolters Kluwer Company); or USP DI (published by 
authority of the United States Pharmacopeial Convention, Inc.); or the 
product is not listed in Sec. 1310.15 of this chapter as an exempt drug 
product. For drug products having formulations not found in the above 
compendiums, the Administrator shall determine, pursuant to a written 
request as specified in Sec. 1310.14 of this chapter, whether the 
active medicinal ingredients are present in quantities considered 
therapeutically significant for purposes of this paragraph; or
    (2) The Administrator has determined pursuant to the criteria in 
Sec. 1310.10 of this chapter that:
    (i) The drug or group of drugs is being diverted to obtain the 
listed chemical for use in the illicit production of a controlled 
substance; and
    (ii) The quantity of ephedrine or other listed chemical contained 
in the drug included in the transaction or multiple transactions equals 
or exceeds the threshold established for that chemical by the 
Administrator;
    (E) Any transaction in a chemical mixture listed in Sec. 1310.13 of 
this chapter.
    (ii) A distribution, importation, or exportation of a tableting 
machine or encapsulating machine except that such term does not include 
a domestic lawful distribution in the usual course of business between 
agents and employees of a single regulated person; in this context, 
agents or employees means individuals under the direct management and 
control of the regulated person.
    (29) The term retail distributor means a distributor whose List I 
chemical activities are restricted to the sale of drug products that 
are regulated as List I chemicals pursuant to 
Sec. 1300.02(b)(28)(i)(D), directly to walk-in customers for personal 
use.
    (30) The term tableting machine means any manual, semi-automatic, 
or fully automatic equipment which may be used for the compaction or 
molding of powdered or granular solids, or semi-solid material, to 
produce coherent solid tablets.

PART 1301--[AMENDED]

    1. The authority citation for part 1301 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 952, 
956, 957, 958, unless otherwise noted.

    2. Section 1301.01 is revised to read as follows:


Sec. 1301.01  Scope of this part 1301.

    Procedures governing the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances pursuant to Sections 301-304 and 1007-1008 of the Act (21 
U.S.C. 821-824 and 957-958) are set forth generally by those sections 
and specifically by the sections of this part.
    3. Section 1301.02 is revised to read as follows:


Sec. 1301.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    4. Part 1301 is amended by revising Secs. 1301.11 through 1301.52 
and the undesignated center headings and by removing Secs. 1301.53 
through 1301.63 and the undesignated center headings:

Registration

Sec.
1301.11  Persons required to register.
1301.12  Separate registrations for separate locations.
1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; 
application forms, fees, contents and signature; coincident 
activities.
1301.14  Filing of application; acceptance for filing; defective 
applications.
1301.15  Additional Information.
1301.16  Amendments to and withdrawal of applications.
1301.17  Special procedures for certain applications.
1301.18  Research protocols.

Exceptions to Registration and Fees

1301.21  Exception from fees.
1301.22  Exemption of agents and employees; affiliated 
practitioners.
1301.23  Exemption of certain military and other personnel.
1301.24  Exemption of law enforcement officials.
1301.25  Registration regarding ocean vessels, aircraft, and other 
entities.
1301.26  Exemptions from import or export requirements for personal 
medical use.

Action on Applications for Registration: Revocation or Suspension of 
Registration

1301.31  Administrative review generally.
1301.32  Action on applications for research in Schedule I 
substances.
1301.33  Application for bulk manufacture of Schedule I and II 
substances.
1301.34  Application for importation of Schedule I and II 
substances.
1301.35  Certificate of registration; denial of registration.
1301.36  Suspension or revocation of registration; suspension of 
registration pending final order; extension of registration pending 
final order.
1301.37  Order to show cause.

Hearings

1301.41  Hearings generally.
1301.42  Purpose of hearing.
1301.43  Request for hearing or appearance; waiver.
1301.44  Burden of proof.
1301.45  Time and place of hearing.
1301.46  Final order.

Modification, Transfer, and Termination of Registration

1301.51  Modification in registration.
1301.52  Termination of registration; transfer of registration; 
distribution upon discontinuance of business.

Registration


Sec. 1301.11  Persons required to register.

    (a) Every person who manufactures, distributes, dispenses, imports, 
or exports any controlled substance or who proposes to engage in the 
manufacture, distribution, dispensing, importation or exportation of 
any controlled substance shall obtain a registration unless exempted by 
law or pursuant to Secs. 1301.22-1301.26. Only persons actually engaged 
in such activities are required to obtain a registration; related or 
affiliated persons who are not engaged in such activities are not 
required to be registered. (For example, a stockholder or parent 
corporation of a corporation manufacturing controlled substances is not 
required to obtain a registration.)


Sec. 1301.12  Separate registrations for separate locations.

    (a) A separate registration is required for each principal place of 
business or professional practice at one general physical location 
where controlled

[[Page 13946]]

substances are manufactured, distributed, imported, exported, or 
dispensed by a person.
    (b) The following locations shall be deemed not to be places where 
controlled substances are manufactured, distributed, or dispensed:
    (1) A warehouse where controlled substances are stored by or on 
behalf of a registered person, unless such substances are distributed 
directly from such warehouse to registered locations other than the 
registered location from which the substances were delivered or to 
persons not required to register by virtue of subsection 302(c)(2) or 
subsection 1007(b)(1)(B) of the Act (21 U.S.C. 822(c)(2) or 
957(b)(1)(B));
    (2) An office used by agents of a registrant where sales of 
controlled substances are solicited, made, or supervised but which 
neither contains such substances (other than substances for display 
purposes or lawful distribution as samples only) nor serves as a 
distribution point for filling sales orders; and
    (3) An office used by a practitioner (who is registered at another 
location) where controlled substances are prescribed but neither 
administered nor otherwise dispensed as a regular part of the 
professional practice of the practitioner at such office, and where no 
supplies of controlled substances are maintained.


Sec. 1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

    (a) Any person who is required to be registered and who is not so 
registered may apply for registration at any time. No person required 
to be registered shall engage in any activity for which registration is 
required until the application for registration is granted and a 
Certificate of Registration is issued by the Administrator to such 
person.
    (b) Any person who is registered may apply to be reregistered not 
more than 60 days before the expiration date of his/her registration, 
except that a bulk manufacturer of Schedule I or II controlled 
substances or an importer of Schedule I or II controlled substances may 
apply to be reregistered no more than 120 days before the expiration 
date of their registration.
    (c) At the time a manufacturer, distributor, researcher, analytical 
lab, importer, exporter or narcotic treatment program is first 
registered, that business activity shall be assigned to one of twelve 
groups, which shall correspond to the months of the year. The 
expiration date of the registrations of all registrants within any 
group will be the last date of the month designated for that group. In 
assigning any of the above business activities to a group, the 
Administration may select a group the expiration date of which is less 
than one year from the date such business activity was registered. If 
the business activity is assigned to a group which has an expiration 
date less than three months from the date of which the business 
activity is registered, the registration shall not expire until one 
year from that expiration date; in all other cases, the registration 
shall expire on the expiration date following the date on which the 
business activity is registered.
    (d) At the time a retail pharmacy, hospital/clinic, practitioner or 
teaching institution is first registered, that business activity shall 
be assigned to one of twelve groups, which shall correspond to the 
months of the year. The expiration date of the registrations of all 
registrants within any group will be the last day of the month 
designated for that group. In assigning any of the above business 
activities to a group, the Administration may select a group the 
expiration date of which is not less than 28 months nor more than 39 
months from the date such business activity was registered. After the 
initial registration period, the registration shall expire 36 months 
from the initial expiration date.
    (e) Any person who is required to be registered and who is not so 
registered, shall make application for registration for one of the 
following groups of controlled substances activities, which are deemed 
to be independent of each other. Application for each registration 
shall be made on the indicated form, and shall be accompanied by the 
indicated fee. Fee payments shall be made in the form of a personal, 
certified, or cashier's check or money order made payable to the ``Drug 
Enforcement Administration''. The application fees are not refundable. 
Any person, when registered to engage in the activities described in 
each subparagraph in this paragraph, shall be authorized to engage in 
the coincident activities described without obtaining a registration to 
engage in such coincident activities, provided that, unless 
specifically exempted, he/she complies with all requirements and duties 
prescribed by law for persons registered to engage in such coincident 
activities. Any person who engages in more than one group of 
independent activities shall obtain a separate registration for each 
group of activities, except as provided in this paragraph under 
coincident activities. A single registration to engage in any group of 
independent activities listed below may include one or more controlled 
substances listed in the schedules authorized in that group of 
independent activities. A person registered to conduct research with 
controlled substances listed in Schedule I may conduct research with 
any substances listed in Schedule I for which he/she has filed and had 
approved a research protocol.
    (1)

----------------------------------------------------------------------------------------------------------------
                                                                 Application  Registration                      
      Business activity           Controlled    DEA application      fee         period          Coincident     
                                  substances         forms        (dollars)      (years)     activities allowed 
----------------------------------------------------------------------------------------------------------------
(i) Manufacturing............  Schedules I      New--225.......          875             1  Schedules I through 
                                through V.      Renewal--225a..          875                 V: May distribute  
                                                                                             that substance or  
                                                                                             class for which    
                                                                                             registration was   
                                                                                             issued; may not    
                                                                                             distribute any     
                                                                                             substance or class 
                                                                                             for which not      
                                                                                             registered.        
                                                                                             Schedules II       
                                                                                             through V: May     
                                                                                             conduct chemical   
                                                                                             analysis and       
                                                                                             preclinical        
                                                                                             research (including
                                                                                             quality control    
                                                                                             analysis) with     
                                                                                             substances listed  
                                                                                             in those schedules 
                                                                                             for which          
                                                                                             authorization as a 
                                                                                             manufacturer was   
                                                                                             issued.            
(ii) Distributing............  Schedules I      New--225.......          438             1  ....................
                                through V.      Renewal--225a..          438                                    

[[Page 13947]]

                                                                                                                
(iii) Dispensing or            Schedules II     New--224.......          210             3  May conduct research
 Instructing (Includes          through V.      Renewal--224a..          210                 and instructional  
 Practitioner Hospital/                                                                      activities with    
 Clinic, Retail Pharmacy,                                                                    those substances   
 Teaching Institution).                                                                      for which          
                                                                                             registration was   
                                                                                             granted, except    
                                                                                             that a mid-level   
                                                                                             practitioner may   
                                                                                             conduct such       
                                                                                             research only to   
                                                                                             the extent         
                                                                                             expressly          
                                                                                             authorized under   
                                                                                             state statute. A   
                                                                                             pharmacist may     
                                                                                             manufacture an     
                                                                                             aqueous or         
                                                                                             oleaginous solution
                                                                                             or solid dosage    
                                                                                             form containing a  
                                                                                             narcotic controlled
                                                                                             substance in       
                                                                                             Schedule II through
                                                                                             V in a proportion  
                                                                                             not exceeding 20   
                                                                                             percent of the     
                                                                                             complete solution, 
                                                                                             compound, or       
                                                                                             mixture.           
(iv) Research................  Schedule I.....  New--225.......           70             1  A researcher may    
                                                Renewal--225a..           70                 manufacture or     
                                                                                             import the basic   
                                                                                             class of substance 
                                                                                             or substances for  
                                                                                             which registration 
                                                                                             was issued,        
                                                                                             provided that such 
                                                                                             manufacture or     
                                                                                             import is set forth
                                                                                             in the protocol    
                                                                                             required in Section
                                                                                             1301.18 and to     
                                                                                             distribute such    
                                                                                             class to persons   
                                                                                             registered or      
                                                                                             authorized to      
                                                                                             conduct research   
                                                                                             with such class of 
                                                                                             substance or       
                                                                                             registered or      
                                                                                             authorized to      
                                                                                             conduct chemical   
                                                                                             analysis with      
                                                                                             controlled         
                                                                                             substances.        
(v) Research.................  Schedules II     New--225.......           70             1  May conduct chemical
                                through V.      Renewal--225a..           70                 analysis with      
                                                                                             controlled         
                                                                                             substances in those
                                                                                             schedules for which
                                                                                             registration was   
                                                                                             issued; manufacture
                                                                                             such substances if 
                                                                                             and to the extent  
                                                                                             that such          
                                                                                             manufacture is set 
                                                                                             forth in a         
                                                                                             statement filed    
                                                                                             with the           
                                                                                             application for    
                                                                                             registration or    
                                                                                             reregistration and 
                                                                                             provided that the  
                                                                                             manufacture is not 
                                                                                             for the purposes of
                                                                                             dosage form        
                                                                                             development; import
                                                                                             such substances for
                                                                                             research purposes; 
                                                                                             distribute such    
                                                                                             substances to      
                                                                                             persons registered 
                                                                                             or authorized to   
                                                                                             conduct chemical   
                                                                                             analysis,          
                                                                                             instructional      
                                                                                             activities, or     
                                                                                             research with such 
                                                                                             substances, and to 
                                                                                             persons exempted   
                                                                                             from registration  
                                                                                             pursuant to Section
                                                                                             1301.24; and       
                                                                                             conduct            
                                                                                             instructional      
                                                                                             activities with    
                                                                                             controlled         
                                                                                             substances.        
(vi) Narcotic Treatment        Narcotic Drugs   New--363.......           70             1  ....................
 Program (including             in Schedules    Renewal--363a..           70                                    
 compounder).                   II through V.                                                                   
(vii) Importing..............  Schedules I      New--225.......          438             1  May distribute that 
                                through V.      Renewal--225a..          438                 substance or class 
                                                                                             for which          
                                                                                             registration was   
                                                                                             issued; may not    
                                                                                             distribute any     
                                                                                             substance or class 
                                                                                             for which not      
                                                                                             registered.        
(viii) Exporting.............  Schedules I      New--225.......          438             1  ....................
                                through V.      Renewal--225a..          438                                    

[[Page 13948]]

                                                                                                                
(ix) Chemical Analysis.......  Schedules I      New--225.......           70             1  May manufacture and 
                                through V.      Renewal--225a..           70                 import controlled  
                                                                                             substances for     
                                                                                             analytical or      
                                                                                             instructional      
                                                                                             activities; may    
                                                                                             distribute such    
                                                                                             substances to      
                                                                                             persons registered 
                                                                                             or authorized to   
                                                                                             conduct chemical   
                                                                                             analysis,          
                                                                                             instructional      
                                                                                             activities, or     
                                                                                             research with such 
                                                                                             substances and to  
                                                                                             persons exempted   
                                                                                             from registration  
                                                                                             pursuant to Section
                                                                                             1301.24; may export
                                                                                             such substances to 
                                                                                             persons in other   
                                                                                             countries          
                                                                                             performing chemical
                                                                                             analysis or        
                                                                                             enforcing laws     
                                                                                             relating to        
                                                                                             controlled         
                                                                                             substances or drugs
                                                                                             in those countries;
                                                                                             and may conduct    
                                                                                             instructional      
                                                                                             activities with    
                                                                                             controlled         
                                                                                             substances.        
----------------------------------------------------------------------------------------------------------------

    (2) DEA Forms 224, 225, and 363 may be obtained at any area office 
of the Administration or by writing to the Registration Unit, Drug 
Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005.
    (3) DEA Forms 224a, 225a, and 363a will be mailed, as applicable, 
to each registered person approximately 60 days before the expiration 
date of his/her registration; if any registered person does not receive 
such forms within 45 days before the expiration date of his/her 
registration, he/she must promptly give notice of such fact and request 
such forms by writing to the Registration Unit of the Administration at 
the foregoing address.
    (f) Each application for registration to handle any basic class of 
controlled substance listed in Schedule I (except to conduct chemical 
analysis with such classes), and each application for registration to 
manufacture a basic class of controlled substance listed in Schedule II 
shall include the Administration Controlled Substances Code Number, as 
set forth in part 1308 of this chapter, for each basic class to be 
covered by such registration.
    (g) Each application for registration to import or export 
controlled substances shall include the Administration Controlled 
Substances Code Number, as set forth in part 1308 of this chapter, for 
each controlled substance whose importation or exportation is to be 
authorized by such registration. Registration as an importer or 
exporter shall not entitle a registrant to import or export any 
controlled substance not specified in such registration.
    (h) Each application for registration to conduct research with any 
basic class of controlled substance listed in Schedule II shall include 
the Administration Controlled Substances Code Number, as set forth in 
part 1308 of this chapter, for each such basic class to be manufactured 
or imported as a coincident activity of that registration. A statement 
listing the quantity of each such basic class of controlled substance 
to be imported or manufactured during the registration period for which 
application is being made shall be included with each such application. 
For purposes of this paragraph only, manufacturing is defined as the 
production of a controlled substance by synthesis, extraction or by 
agricultural/horticultural means.
    (i) Each application shall include all information called for in 
the form, unless the item is not applicable, in which case this fact 
shall be indicated.
    (j) Each application, attachment, or other document filed as part 
of an application, shall be signed by the applicant, if an individual; 
by a partner of the applicant, if a partnership; or by an officer of 
the applicant, if a corporation, corporate division, association, trust 
or other entity. An applicant may authorize one or more individuals, 
who would not otherwise be authorized to do so, to sign applications 
for the applicant by filing with the Registration Unit of the 
Administration a power of attorney for each such individual. The power 
of attorney shall be signed by a person who is authorized to sign 
applications under this paragraph and shall contain the signature of 
the individual being authorized to sign applications. The power of 
attorney shall be valid until revoked by the applicant.


Sec. 1301.14  Filing of application; acceptance for filing; defective 
applications.

    (a) All applications for registration shall be submitted for filing 
to the Registration Unit, Drug Enforcement Administration, Department 
of Justice, Post Office Box 28083, Central Station, Washington, DC 
20005. The appropriate registration fee and any required attachments 
must accompany the application.
    (b) Any person required to obtain more than one registration may 
submit all applications in one package. Each application must be 
complete and should not refer to any accompanying application for 
required information.
    (c) Applications submitted for filing are dated upon receipt. If 
found to be complete, the application will be accepted for filing. 
Applications failing to comply with the requirements of this part will 
not generally be accepted for filing. In the case of minor defects as 
to completeness, the Administrator may accept the application for 
filing with a request to the applicant for additional information. A 
defective application will be returned to the applicant within 10 days 
following its receipt with a statement of the reason for not accepting 
the application for filing. A defective application may be corrected 
and resubmitted for filing at any time; the Administrator shall accept 
for filing any application upon resubmission by the applicant, whether 
complete or not.
    (d) Accepting an application for filing does not preclude any 
subsequent request for additional information pursuant to Sec. 1301.15 
and has no bearing on whether the application will be granted.


Sec. 1301.15  Additional information.

    The Administrator may require an applicant to submit such documents 
or

[[Page 13949]]

written statements of fact relevant to the application as he/she deems 
necessary to determine whether the application should be granted. The 
failure of the applicant to provide such documents or statements within 
a reasonable time after being requested to do so shall be deemed to be 
a waiver by the applicant of an opportunity to present such documents 
or facts for consideration by the Administrator in granting or denying 
the application.


Sec. 1301.16  Amendments to and withdrawal of applications.

    (a) An application may be amended or withdrawn without permission 
of the Administrator at any time before the date on which the applicant 
receives an order to show cause pursuant to Sec. 1301.37. An 
application may be amended or withdrawn with permission of the 
Administrator at any time where good cause is shown by the applicant or 
where the amendment or withdrawal is in the public interest.
    (b) After an application has been accepted for filing, the request 
by the applicant that it be returned or the failure of the applicant to 
respond to official correspondence regarding the application, when sent 
by registered or certified mail, return receipt requested, shall be 
deemed to be a withdrawal of the application.


Sec. 1301.17  Special procedures for certain applications.

    (a) If, at the time of application for registration of a new 
pharmacy, the pharmacy has been issued a license from the appropriate 
State licensing agency, the applicant may include with his/her 
application an affidavit as to the existence of the State license in 
the following form:

Affidavit for New Pharmacy

    I, ____________________, the ____________________ (Title of 
officer, official, partner, or other position) of 
____________________ (Corporation, partnership, or sole proprietor), 
doing business as ____________________ (Store name) at 
____________________ (Number and Street), ____________________ 
(City) ____________ (State) ____________ (Zip code), hereby certify 
that said store was issued a pharmacy permit No. ________ by the 
________________ (Board of Pharmacy or Licensing Agency) of the 
State of ____________ on ____________ (Date).
    This statement is submitted in order to obtain a Drug 
Enforcement Administration registration number. I understand that if 
any information is false, the Administration may immediately suspend 
the registration for this store and commence proceedings to revoke 
under 21 U.S.C. 824(a) because of the danger to public health and 
safety. I further understand that any false information contained in 
this affidavit may subject me personally and the above-named 
corporation/partnership/business to prosecution under 21 U.S.C. 843, 
the penalties for conviction of which include imprisonment for up to 
4 years, a fine of not more than $30,000 or both.
----------------------------------------------------------------------
Signature (Person who signs Application for Registration)
State of---------------------------------------------------------------
County of--------------------------------------------------------------
    Subscribed to and sworn before me this ________ day of ________, 
19______.
----------------------------------------------------------------------
Notary Public
    (b) Whenever the ownership of a pharmacy is being transferred from 
one person to another, if the transferee owns at least one other 
pharmacy licensed in the same State as the one the ownership of which 
is being transferred, the transferee may apply for registration prior 
to the date of transfer. The Administrator may register the applicant 
and authorize him to obtain controlled substances at the time of 
transfer. Such registration shall not authorize the transferee to 
dispense controlled substances until the pharmacy has been issued a 
valid State license. The transferee shall include with his/her 
application the following affidavit:

Affidavit for Transfer of Pharmacy

    I, ____________________, the ____________________ (Title of 
officer, official, partner or other position) of 
____________________ (Corporation, partnership, or sole proprietor), 
doing business as ____________________ (Store name) hereby certify:
    (1) That said company was issued a pharmacy permit 
No.____________by the ____________________ (Board of Pharmacy of 
Licensing Agency) of the State of ____________ and a DEA 
Registration Number ____________________ for a pharmacy located at 
____________________ (Number and Street) ____________ (City) 
____________ (State) ____________ (Zip Code); and
    (2) That said company is acquiring the pharmacy business of 
____________________ (Name of Seller) doing business 
as____________________with DEA Registration Number ____________ on 
or about ____________ (Date of Transfer) and that said company has 
applied (or will apply on ____________ (Date) for a pharmacy permit 
from the board of pharmacy (or licensing agency) of the State of 
____________ to do business as ____________________ (Store name) at 
____________________ (Number and Street) ____________________ (City) 
____________ (State) ____________ (Zip Code).
    This statement is submitted in order to obtain a Drug 
Enforcement Administration registration number.
    I understand that if a DEA registration number is issued, the 
pharmacy may acquire controlled substances but may not dispense them 
until a pharmacy permit or license is issued by the State board of 
pharmacy or licensing agency.
    I understand that if any information is false, the Administration 
may immediately suspend the registration for this store and commence 
proceedings to revoke under 21 U.S.C. 824(a) because of the danger to 
public health and safety. I further understand that any false 
information contained in this affidavit may subject me personally to 
prosecution under 21 U.S.C. 843, the penalties for conviction of which 
include imprisonment for up to 4 years, a fine of not more than $30,000 
or both.

----------------------------------------------------------------------
Signature (Person who signs Application for Registration)
State of---------------------------------------------------------------
County of--------------------------------------------------------------
    Subscribed to and sworn before me this____day of____________, 
19____.
----------------------------------------------------------------------
Notary Public

    (c) The Administrator shall follow the normal procedures for 
approving an application to verify the statements in the affidavit. If 
the statements prove to be false, the Administrator may revoke the 
registration on the basis of section 304(a)(1) of the Act (21 U.S.C. 
824(a)(1)) and suspend the registration immediately by pending 
revocation on the basis of section 304(d) of the Act (21 U.S.C. 
824(d)). At the same time, the Administrator may seize and place under 
seal all controlled substances possessed by the applicant under section 
304(f) of the Act (21 U.S.C. 824(f)). Intentional misuse of the 
affidavit procedure may subject the applicant to prosecution for fraud 
under section 403(a)(4) of the Act (21 U.S.C. 843(a)(4)), and obtaining 
controlled substances through registration by fraudulent means may 
subject the applicant to prosecution under section 403(a)(3) of the Act 
(21 U.S.C. 843(a)(3)). The penalties for conviction of either offense 
include imprisonment for up to 4 years, a fine not exceeding $30,000 or 
both.


Sec. 1301.18 Research protocols.

    (a) A protocol to conduct research with controlled substances 
listed in Schedule I shall be in the following form and contain the 
following information where applicable:
    (1) Investigator:
    (i) Name, address, and DEA registration number; if any.
    (ii) Institutional affiliation.
    (iii) Qualifications, including a curriculum vitae and an 
appropriate bibliography (list of publications).
    (2) Research project:
    (i) Title of project.
    (ii) Statement of the purpose.
    (iii) Name of the controlled substances or substances involved and 
the amount of each needed.

[[Page 13950]]

    (iv) Description of the research to be conducted, including the 
number and species of research subjects, the dosage to be administered, 
the route and method of administration, and the duration of the 
project.
    (v) Location where the research will be conducted.
    (vi) Statement of the security provisions for storing the 
controlled substances (in accordance with Sec. 1301.75) and for 
dispensing the controlled substances in order to prevent diversion.
    (vii) If the investigator desires to manufacture or import any 
controlled substance listed in paragraph (a)(2)(iii) of this section, a 
statement of the quantity to be manufactured or imported and the 
sources of the chemicals to be used or the substance to be imported.
    (3) Authority:
    (i) Institutional approval.
    (ii) Approval of a Human Research Committee for human studies.
    (iii) Indication of an approved active Notice of Claimed 
Investigational Exemption for a New Drug (number).
    (iv) Indication of an approved funded grant (number), if any.
    (b) In the case of a clinical investigation with controlled 
substances listed in Schedule I, the applicant shall submit three 
copies of a Notice of Claimed Investigational Exemption for a New Drug 
(IND) together with a statement of the security provisions (as 
proscribed in paragraph (a)(2)(vi) of this section for a research 
protocol) to, and have such submission approved by, the Food and Drug 
Administration as required in 21 U.S.C. 355(i) and Sec. 130.3 of this 
title. Submission of this Notice and statement to the Food and Drug 
Administration shall be in lieu of a research protocol to the 
Administration as required in paragraph (a) of this section. The 
applicant, when applying for registration with the Administration, 
shall indicate that such notice has been submitted to the Food and Drug 
Administration by submitting to the Administration with his/her DEA 
Form 225 three copies of the following certificate:

    I hereby certify that on ____________________ (Date), pursuant 
to 21 U.S.C. 355(i) and 21 CFR 130.3, I, ____________________ (Name 
and Address of IND Sponsor) submitted a Notice of Claimed 
Investigational Exemption for a New Drug (IND) to the Food and Drug 
Administration for:
----------------------------------------------------------------------
(Name of Investigational Drug).

----------------------------------------------------------------------
(Date)

----------------------------------------------------------------------
(Signature of Applicant).

    (c) In the event that the registrant desires to increase the 
quantity of a controlled substance used for an approved research 
project, he/she shall submit a request to the Registration Unit, Drug 
Enforcement Administration, Post Office Box 28083, Central Station, 
Washington, DC 20005, by registered mail, return receipt requested. The 
request shall contain the following information: DEA registration 
number; name of the controlled substance or substances and the quantity 
of each authorized in the approved protocol; and the additional 
quantity of each desired. Upon return of the receipt, the registrant 
shall be authorized to purchase the additional quantity of the 
controlled substance or substances specified in the request. The 
Administration shall review the letter and forward it to the Food and 
Drug Administration together with the Administration comments. The Food 
and Drug Administration shall approve or deny the request as an 
amendment to the protocol and so notify the registrant. Approval of the 
letter by the Food and Drug Administration shall authorize the 
registrant to use the additional quantity of the controlled substance 
in the research project.
    (d) In the event the registrant desires to conduct research beyond 
the variations provided in the registrant's approved protocol 
(excluding any increase in the quantity of the controlled substance 
requested for his/her research project as outlined in paragraph (c) of 
this section), he/she shall submit three copies of a supplemental 
protocol in accordance with paragraph (a) of this section describing 
the new research and omitting information in the supplemental protocol 
which has been stated in the original protocol. Supplemental protocols 
shall be processed and approved or denied in the same manner as 
original research protocols.

Exceptions to Registration and Fees


Sec. 1301.21  Exemption from fees.

    (a) The Administrator shall exempt from payment of an application 
fee for registration or reregistration:
    (1) Any hospital or other institution which is operated by an 
agency of the United States (including the U.S. Army, Navy, Marine 
Corps., Air Force, and Coast Guard), of any State, or any political 
subdivision or agency thereof.
    (2) Any individual practitioner who is required to obtain an 
individual registration in order to carry out his or her duties as an 
official of an agency of the United States (including the U.S. Army, 
Navy, Marine Corps, Air Force, and Coast Guard), of any State, or any 
political subdivision or agency thereof.
    (b) In order to claim exemption from payment of a registration or 
reregistration application fee, the registrant shall have completed the 
certification on the appropriate application form, wherein the 
registrant's superior (if the registrant is an individual) or officer 
(if the registrant is an agency) certifies to the status and address of 
the registrant and to the authority of the registrant to acquire, 
possess, or handle controlled substances.
    (c) Exemption from payment of a registration or reregistration 
application fee does not relieve the registrant of any other 
requirements or duties prescribed by law.


Sec. 1301.22  Exemption of agents and employees; affiliated 
practitioners.

    (a) The requirement of registration is waived for any agent or 
employee of a person who is registered to engage in any group of 
independent activities, if such agent or employee is acting in the 
usual course of his/her business or employment.
    (b) An individual practitioner who is an agent or employee of 
another practitioner (other than a mid-level practitioner) registered 
to dispense controlled substances may, when acting in the normal course 
of business or employment, administer or dispense (other than by 
issuance of prescription) controlled substances if and to the extent 
that such individual practitioner is authorized or permitted to do so 
by the jurisdiction in which he or she practices, under the 
registration of the employer or principal practitioner in lieu of being 
registered him/herself.
    (c) An individual practitioner who is an agent or employee of a 
hospital or other institution may, when acting in the normal course of 
business or employment, administer, dispense, or prescribe controlled 
substances under the registration of the hospital or other institution 
which is registered in lieu of being registered him/herself, provided 
that:
    (1) Such dispensing, administering or prescribing is done in the 
usual course of his/her professional practice;
    (2) Such individual practitioner is authorized or permitted to do 
so by the jurisdiction in which he/she is practicing;
    (3) The hospital or other institution by whom he/she is employed 
has verified that the individual practitioner is so permitted to 
dispense, administer, or prescribe drugs within the jurisdiction;

[[Page 13951]]

    (4) Such individual practitioner is acting only within the scope of 
his/her employment in the hospital or institution;
    (5) The hospital or other institution authorizes the individual 
practitioner to administer, dispense or prescribe under the hospital 
registration and designates a specific internal code number for each 
individual practitioner so authorized. The code number shall consist of 
numbers, letters, or a combination thereof and shall be a suffix to the 
institution's DEA registration number, preceded by a hyphen (e.g., 
APO123456-10 or APO123456-A12); and
    (6) A current list of internal codes and the corresponding 
individual practitioners is kept by the hospital or other institution 
and is made available at all times to other registrants and law 
enforcement agencies upon request for the purpose of verifying the 
authority of the prescribing individual practitioner.


Sec. 1301.23  Exemption of certain military and other personnel.

    (a) The requirement of registration is waived for any official of 
the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, Public 
Health Service, or Bureau of Prisons who is authorized to prescribe, 
dispense, or administer, but not to procure or purchase, controlled 
substances in the course of his/her official duties. Such officials 
shall follow procedures set forth in part 1306 of this chapter 
regarding prescriptions, but shall state the branch of service or 
agency (e.g., ``U.S. Army'' or ``Public Health Service'') and the 
service identification number of the issuing official in lieu of the 
registration number required on prescription forms. The service 
identification number for a Public Health Service employee is his/her 
Social Security identification number.
    (b) The requirement of registration is waived for any official or 
agency of the U.S. Army, Navy, Marine Corps, Air Force, Coast Guard, or 
Public Health Service who or which is authorized to import or export 
controlled substances in the course of his/her official duties.
    (c) If any official exempted by this section also engages as a 
private individual in any activity or group of activities for which 
registration is required, such official shall obtain a registration for 
such private activities.


Sec. 1301.24  Exemption of law enforcement officials.

    (a) The requirement of registration is waived for the following 
persons in the circumstances described in this section:
    (1) Any officer or employee of the Administration, any officer of 
the U.S. Customs Service, any officer or employee of the United States 
Food and Drug Administration, and any other Federal officer who is 
lawfully engaged in the enforcement of any Federal law relating to 
controlled substances, drugs or customs, and is duly authorized to 
possess or to import or export controlled substances in the course of 
his/her official duties; and
    (2) Any officer or employee of any State, or any political 
subdivision or agency thereof, who is engaged in the enforcement of any 
State or local law relating to controlled substances and is duly 
authorized to possess controlled substances in the course of his/her 
official duties.
    (b) Any official exempted by this section may, when acting in the 
course of his/her official duties, procure any controlled substance in 
the course of an inspection, in accordance with Sec. 1316.03(d) of this 
chapter, or in the course of any criminal investigation involving the 
person from whom the substance was procured, and may possess any 
controlled substance and distribute any such substance to any other 
official who is also exempted by this section and acting in the course 
of his/her official duties.
    (c) In order to enable law enforcement agency laboratories, 
including laboratories of the Administration, to obtain and transfer 
controlled substances for use as standards in chemical analysis, such 
laboratories shall obtain annually a registration to conduct chemical 
analysis. Such laboratories shall be exempted from payment of a fee for 
registration. Laboratory personnel, when acting in the scope of their 
official duties, are deemed to be officials exempted by this section 
and within the activity described in section 515(d) of the Act (21 
U.S.C. 885(d)). For purposes of this paragraph, laboratory activities 
shall not include field or other preliminary chemical tests by 
officials exempted by this section.
    (d) In addition to the activities authorized under a registration 
to conduct chemical analysis pursuant to Sec. 1301.13(e)(1)(ix), 
laboratories of the Administration shall be authorized to manufacture 
or import controlled substances for any lawful purpose, to distribute 
or export such substances to any person, and to import and export such 
substances in emergencies without regard to the requirements of part 
1312 of this chapter if a report concerning the importation or 
exportation is made to the Drug Operations Section of the 
Administration within 30 days of such importation or exportation.


Sec. 1301.25  Registration regarding ocean vessels, aircraft, and other 
entities.

    (a) If acquired by and dispensed under the general supervision of a 
medical officer described in paragraph (b) of this section, or the 
master or first officer of the vessel under the circumstances described 
in paragraph (d) of this section, controlled substances may be held for 
stocking, be maintained in, and dispensed from medicine chests, first 
aid packets, or dispensaries:
    (1) On board any vessel engaged in international trade or in trade 
between ports of the United States and any merchant vessel belonging to 
the U.S. Government;
    (2) On board any aircraft operated by an air carrier under a 
certificate of permit issued pursuant to the Federal Aviation Act of 
1958 (49 U.S.C. 1301); and
    (3) In any other entity of fixed or transient location approved by 
the Administrator as appropriate for application of this section (e.g., 
emergency kits at field sites of an industrial firm).
    (b) A medical officer shall be:
    (1) Licensed in a state as a physician;
    (2) Employed by the owner or operator of the vessel, aircraft or 
other entity; and
    (3) Registered under the Act at either of the following locations:
    (i) The principal office of the owner or operator of the vessel, 
aircraft or other entity or
    (ii) At any other location provided that the name, address, 
registration number and expiration date as they appear on his/her 
Certificate of Registration (DEA Form 223) for this location are 
maintained for inspection at said principal office in a readily 
retrievable manner.
    (c) A registered medical officer may serve as medical officer for 
more than one vessel, aircraft, or other entity under a single 
registration, unless he/she serves as medical officer for more than one 
owner or operator, in which case he/she shall either maintain a 
separate registration at the location of the principal office of each 
such owner or operator or utilize one or more registrations pursuant to 
paragraph (b)(3)(ii) of this section.
    (d) If no medical officer is employed by the owner or operator of a 
vessel, or in the event such medical officer is not accessible and the 
acquisition of controlled substances is required, the master or first 
officer of the vessel, who shall not be registered under the Act, may 
purchase controlled substances

[[Page 13952]]

from a registered manufacturer or distributor, or from an authorized 
pharmacy as described in paragraph (f) of this section, by following 
the procedure outlined below:
    (1) The master or first officer of the vessel must personally 
appear at the vendor's place of business, present proper identification 
(e.g., Seaman's photographic identification card) and a written 
requisition for the controlled substances.
    (2) The written requisition must be on the vessel's official 
stationery or purchase order form and must include the name and address 
of the vendor, the name of the controlled substance, description of the 
controlled substance (dosage form, strength and number or volume per 
container) number of containers ordered, the name of the vessel, the 
vessel's official number and country of registry, the owner or operator 
of the vessel, the port at which the vessel is located, signature of 
the vessel's officer who is ordering the controlled substances and the 
date of the requisition.
    (3) The vendor may, after verifying the identification of the 
vessel's officer requisitioning the controlled substances, deliver the 
control substances to that officer. The transaction shall be 
documented, in triplicate, on a record of sale in a format similar to 
that outlined in paragraph (d)(4) of this section. The vessel's 
requisition shall be attached to copy 1 of the record of sale and filed 
with the controlled substances records of the vendor, copy 2 of the 
record of sale shall be furnished to the officer of the vessel and 
retained aboard the vessel, copy 3 of the record of sale shall be 
forwarded to the nearest DEA Division Office within 15 days after the 
end of the month in which the sale is made.
    (4) The vendor's record of sale should be similar to, and must 
include all the information contained in, the below listed format.

Sale of Controlled Substances to Vessels

(Name of registrant)---------------------------------------------------

(Address of registrant)------------------------------------------------

(DEA registration number)----------------------------------------------

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Number of                                                 Packages                       
                         Line No.                           packages ordered   Size of packages   Name of product      distributed      Date distributed
--------------------------------------------------------------------------------------------------------------------------------------------------------
1........................................................  .................  .................  .................  .................  .................
2........................................................  .................  .................  .................  .................  .................
3........................................................  .................  .................  .................  .................  .................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Footnote: Line numbers may be continued according to needs of the vendor.                                                                               

Number of lines completed----------------------------------------------
Name of vessel---------------------------------------------------------
Vessel's official number-----------------------------------------------
Vessel's country of registry-------------------------------------------
Owner or operator of the vessel----------------------------------------

Name and title of vessel's officer who presented the requisition 
________
Signature of vessel's officer who presented the requisition ________

    (e) Any medical officer described in paragraph (b) of this section 
shall, in addition to complying with all requirements and duties 
prescribed for registrants generally, prepare an annual report as of 
the date on which his/her registration expires, which shall give in 
detail an accounting for each vessel, aircraft, or other entity, and a 
summary accounting for all vessels, aircraft, or other entities under 
his/her supervision for all controlled substances purchased, dispensed 
or disposed of during the year. The medical officer shall maintain this 
report with other records required to be kept under the Act and, upon 
request, deliver a copy of the report to the Administration. The 
medical officer need not be present when controlled substances are 
dispensed, if the person who actually dispensed the controlled 
substances is responsible to the medical officer to justify his/her 
actions.
    (f) Any registered pharmacy that wishes to distribute controlled 
substances pursuant to this section shall be authorized to do so, 
provided:
    (1) The registered pharmacy notifies the nearest Division Office of 
the Administration of its intention to so distribute controlled 
substances prior to the initiation of such activity. This notification 
shall be by registered mail and shall contain the name, address, and 
registration number of the pharmacy as well as the date upon which such 
activity will commence; and
    (2) Such activity is authorized by state law; and
    (3) The total number of dosage units of all controlled substances 
distributed by the pharmacy during any calendar year in which the 
pharmacy is registered to dispense does not exceed the limitations 
imposed upon such distribution by Sec. 1307.11(a)(4) and (b) of this 
chapter.
    (g) Owners or operators of vessels, aircraft, or other entities 
described in this section shall not be deemed to possess or dispense 
any controlled substance acquired, stored and dispensed in accordance 
with this section. Additionally, owners or operators of vessels, 
aircraft, or other entities described in this section or in Article 32 
of the Single Convention on Narcotic Drugs, 1961, or in Article 14 of 
the Convention on Psychotropic Substances, 1971, shall not be deemed to 
import or export any controlled substances purchased and stored in 
accordance with that section or applicable article.
    (h) The Master of a vessel shall prepare a report for each calendar 
year which shall give in detail an accounting for all controlled 
substances purchased, dispensed, or disposed of during the year. The 
Master shall file this report with the medical officer employed by the 
owner or operator of his/her vessel, if any, or, if not, he/she shall 
maintain this report with other records required to be kept under the 
Act and, upon request, deliver a copy of the report to the 
Administration.
    (i) Controlled substances acquired and possessed in accordance with 
this section shall not be distributed to persons not under the general 
supervision of the medical officer employed by the owner or operator of 
the vessel, aircraft, or other entity, except in accordance with 
Sec. 1307.21 of this chapter.


Sec. 1301.26  Exemptions from import or export requirements for 
personal medical use.

    Any individual who has in his/her possession a controlled substance 
listed in schedules II, III, IV, or V, which he/she has lawfully 
obtained for his/her personal medical use, or for administration to an 
animal accompanying him/her, may enter or depart the United States with 
such substance notwithstanding sections 1002-1005 of the Act (21 U.S.C. 
952-955), providing the following conditions are met:
    (a) The controlled substance is in the original container in which 
it was dispensed to the individual; and
    (b) The individual makes a declaration to an appropriate official 
of the U.S. Customs Service stating:
    (1) That the controlled substance is possessed for his/her personal 
use, or for an animal accompanying him/her; and

[[Page 13953]]

    (2) The trade or chemical name and the symbol designating the 
schedule of the controlled substance if it appears on the container 
label, or, if such name does not appear on the label, the name and 
address of the pharmacy or practitioner who dispensed the substance and 
the prescription number, if any; and
    (c) The importation of the controlled substance for personal 
medical use is authorized or permitted under other Federal laws and 
state law.

Action on Application for Registration: Revocation or Suspension of 
Registration


Sec. 1301.31  Administrative review generally.

    The Administrator may inspect, or cause to be inspected, the 
establishment of an applicant or registrant, pursuant to subpart A of 
part 1316 of this chapter. The Administrator shall review the 
application for registration and other information gathered by the 
Administrator regarding an applicant in order to determine whether the 
applicable standards of section 303 (21 U.S.C. 823) or section 1008 (21 
U.S.C. 958) of the Act have been met by the applicant.


Sec. 1301.32  Action on applications for research in Schedule I 
substances.

    (a) In the case of an application for registration to conduct 
research with controlled substances listed in Schedule I, the 
Administrator shall process the application and protocol and forward a 
copy of each to the Secretary of Health and Human Services (Secretary) 
within 7 days after receipt. The Secretary shall determine the 
qualifications and competency of the applicant, as well as the merits 
of the protocol (and shall notify the Administrator of his/her 
determination) within 21 days after receipt of the application and 
complete protocol, except that in the case of a clinical investigation, 
the Secretary shall have 30 days to make such determination and notify 
the Administrator. The Secretary, in determining the merits of the 
protocol, shall consult with the Administrator as to effective 
procedures to safeguard adequately against diversion of such controlled 
substances from legitimate medical or scientific use.
    (b) An applicant whose protocol is defective shall be notified by 
the Secretary within 21 days after receipt of such protocol from the 
Administrator (or in the case of a clinical investigation within 30 
days), and he/she shall be requested to correct the existing defects 
before consideration shall be given to his/her submission.
    (c) If the Secretary determines the applicant qualified and 
competent and the research protocol meritorious, he/she shall notify 
the Administrator in writing of such determination. The Administrator 
shall issue a certificate of registration within 10 days after receipt 
of this notice, unless he/she determines that the certificate of 
registration should be denied on a ground specified in section 304(a) 
of the Act (21 U.S.C. 824(a)). In the case of a supplemental protocol, 
a replacement certificate of registration shall be issued by the 
Administrator.
    (d) If the Secretary determines that the protocol is not 
meritorious and/or the applicant is not qualified or competent, he/she 
shall notify the Administrator in writing setting forth the reasons for 
such determination. If the Administrator determines that grounds exist 
for the denial of the application, he/she shall within 10 days issue an 
order to show cause pursuant to Sec. 1301.37 and, if requested by the 
applicant, hold a hearing on the application pursuant to Section 
1301.41. If the grounds for denial of the application include a 
determination by the Secretary, the Secretary or his duly authorized 
agent shall furnish testimony and documents pertaining to his 
determination at such hearing.
    (e) Supplemental protocols will be processed in the same manner as 
original research protocols. If the processing of an application or 
research protocol is delayed beyond the time limits imposed by this 
section, the applicant shall be so notified in writing.


Sec. 1301.33  Application for bulk manufacture of Schedule I and II 
substances.

    (a) In the case of an application for registration or 
reregistration to manufacture in bulk a basic class of controlled 
substance listed in Schedule I or II, the Administrator shall, upon the 
filing of such application, publish in the Federal Register a notice 
naming the applicant and stating that such applicant has applied to be 
registered as a bulk manufacturer of a basic class of narcotic or 
nonnarcotic controlled substance, which class shall be identified. A 
copy of said notice shall be mailed simultaneously to each person 
registered as a bulk manufacturer of that basic class and to any other 
applicant therefor. Any such person may, within 60 days from the date 
of publication of the notice in the Federal Register, file with the 
Administrator written comments on or objections to the issuance of the 
proposed registration.
    (b) In order to provide adequate competition, the Administrator 
shall not be required to limit the number of manufacturers in any basic 
class to a number less than that consistent with maintenance of 
effective controls against diversion solely because a smaller number is 
capable of producing an adequate and uninterrupted supply.
    (c) This section shall not apply to the manufacture of basic 
classes of controlled substances listed in Schedules I or II as an 
incident to research or chemical analysis as authorized in 
Sec. 1301.13(e)(1).


Sec. 1301.34  Application for importation of Schedule I and II 
substances.

    (a) In the case of an application for registration or 
reregistration to import a controlled substance listed in Schedule I or 
II, under the authority of section 1002(a)(2)(B) of the Act (21 U.S.C. 
952(a)(2)(B)), the Administrator shall, upon the filing of such 
application, publish in the Federal Register a notice naming the 
applicant and stating that such applicant has applied to be registered 
as an importer of a Schedule I or II controlled substance, which 
substance shall be identified. A copy of said notice shall be mailed 
simultaneously to each person registered as a bulk manufacturer of that 
controlled substance and to any other applicant therefor. Any such 
person may, within 30 days from the date of publication of the notice 
in the Federal Register, file written comments on or objections to the 
issuance of the proposed registration, and may, at the same time, file 
a written request for a hearing on the application pursuant to 
Sec. 1301.43. If a hearing is requested, the Administrator shall hold a 
hearing on the application in accordance with Sec. 1301.41. Notice of 
the hearing shall be published in the Federal Register, and shall be 
mailed simultaneously to the applicant and to all persons to whom 
notice of the application was mailed. Any such person may participate 
in the hearing by filing a notice of appearance in accordance with 
Sec. 1301.43 of this chapter. Notice of the hearing shall contain a 
summary of all comments and objections filed regarding the application 
and shall state the time and place for the hearing, which shall not be 
less than 30 days after the date of publication of such notice in the 
Federal Register. A hearing pursuant to this section may be 
consolidated with a hearing held pursuant to Sec. 1301.35 or 
Sec. 1301.36 of this part.
    (b) The Administrator shall register an applicant to import a 
controlled substance listed in Schedule I or II if he/she determines 
that such registration is consistent with the public interest and with 
U.S. obligations under international treaties, conventions, or

[[Page 13954]]

protocols in effect on May 1, 1971. In determining the public interest, 
the following factors shall be considered:
    (1) Maintenance of effective controls against diversion of 
particular controlled substances and any controlled substance in 
Schedule I or II compounded therefrom into other than legitimate 
medical, scientific research, or industrial channels, by limiting the 
importation and bulk manufacture of such controlled substances to a 
number of establishments which can produce an adequate and 
uninterrupted supply of these substances under adequately competitive 
conditions for legitimate medical, scientific, research, and industrial 
purposes;
    (2) Compliance with applicable State and local law;
    (3) Promotion of technical advances in the art of manufacturing 
these substances and the development of new substances;
    (4) Prior conviction record of applicant under Federal and State 
laws relating to the manufacture, distribution, or dispensing of such 
substances;
    (5) Past experience in the manufacture of controlled substances, 
and the existence in the establishment of effective control against 
diversion;
    (6) That the applicant will be permitted to import only:
    (i) Such amounts of crude opium, poppy straw, concentrate of poppy 
straw, and coca leaves as the Administrator finds to be necessary to 
provide for medical, scientific, or other legitimate purposes; or
    (ii) Such amounts of any controlled substances listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for 
the medical, scientific, or other legitimate needs of the United States 
during an emergency in which domestic supplies of such substances are 
found by the Administrator to be inadequate; or
    (iii) Such amounts of any controlled substance listed in Schedule I 
or II as the Administrator shall find to be necessary to provide for 
the medical, scientific, or other legitimate needs of the United States 
in any case in which the Administrator finds that competition among 
domestic manufacturers of the controlled substance is inadequate and 
will not be rendered adequate by the registration of additional 
manufacturers under section 303 of the Act (21 U.S.C. 823); or
    (iv) Such limited quantities of any controlled substance listed in 
Schedule I or II as the Administrator shall find to be necessary for 
scientific, analytical or research uses; and
    (7) Such other factors as may be relevant to and consistent with 
the public health and safety.
    (c) In determining whether the applicant can and will maintain 
effective controls against diversion within the meaning of paragraph 
(b) of this section, the Administrator shall consider among other 
factors:
    (1) Compliance with the security requirements set forth in 
Secs. 1301.71-1301.76; and
    (2) Employment of security procedures to guard against in-transit 
losses within and without the jurisdiction of the United States.
    (d) In determining whether competition among the domestic 
manufacturers of a controlled substance is adequate within the meaning 
of paragraphs (b)(1) and (b)(6)(iii) of this section, as well as 
section 1002(a)(2)(B) of the Act (21 U.S.C. 952(a)(2)(B)), the 
Administrator shall consider:
    (1) The extent of price rigidity in the light of changes in:
    (i) raw materials and other costs and
    (ii) conditions of supply and demand;
    (2) The extent of service and quality competition among the 
domestic manufacturers for shares of the domestic market including:
    (i) Shifts in market shares and
    (ii) Shifts in individual customers among domestic manufacturers;
    (3) The existence of substantial differentials between domestic 
prices and the higher of prices generally prevailing in foreign markets 
or the prices at which the applicant for registration to import is 
committed to undertake to provide such products in the domestic market 
in conformity with the Act. In determining the existence of substantial 
differentials hereunder, appropriate consideration should be given to 
any additional costs imposed on domestic manufacturers by the 
requirements of the Act and such other cost-related and other factors 
as the Administrator may deem relevant. In no event shall an importer's 
offering prices in the United States be considered if they are lower 
than those prevailing in the foreign market or markets from which the 
importer is obtaining his/her supply;
    (4) The existence of competitive restraints imposed upon domestic 
manufacturers by governmental regulations; and
    (5) Such other factors as may be relevant to the determinations 
required under this paragraph.
    (e) In considering the scope of the domestic market, consideration 
shall be given to substitute products which are reasonably 
interchangeable in terms of price, quality and use.
    (f) The fact that the number of existing manufacturers is small 
shall not demonstrate, in and of itself, that adequate competition 
among them does not exist.


Sec. 1301.35  Certificate of registration; denial of registration.

    (a) The Administrator shall issue a Certificate of Registration 
(DEA Form 223) to an applicant if the issuance of registration or 
reregistration is required under the applicable provisions of sections 
303 or 1008 of the Act (21 U.S.C. 823 and 958). In the event that the 
issuance of registration or reregistration is not required, the 
Administrator shall deny the application. Before denying any 
application, the Administrator shall issue an order to show cause 
pursuant to Sec. 1301.37 and, if requested by the applicant, shall hold 
a hearing on the application pursuant to Sec. 1301.41.
    (b) If in response to a show cause order a hearing is requested by 
an applicant for registration or reregistration to manufacture in bulk 
a basic class of controlled substance listed in Schedule I or II, 
notice that a hearing has been requested shall be published in the 
Federal Register and shall be mailed simultaneously to the applicant 
and to all persons to whom notice of the application was mailed. Any 
person entitled to file comments or objections to the issuance of the 
proposed registration pursuant to Sec. 1301.33(a) may participate in 
the hearing by filing notice of appearance in accordance with 
Sec. 1301.43. Such persons shall have 30 days to file a notice of 
appearance after the date of publication of the notice of a request for 
a hearing in the Federal Register.
    (c) The Certificate of Registration (DEA Form 223) shall contain 
the name, address, and registration number of the registrant, the 
activity authorized by the registration, the schedules and/or 
Administration Controlled Substances Code Number (as set forth in part 
1308 of this chapter) of the controlled substances which the registrant 
is authorized to handle, the amount of fee paid (or exemption), and the 
expiration date of the registration. The registrant shall maintain the 
certificate of registration at the registered location in a readily 
retrievable manner and shall permit inspection of the certificate by 
any official, agent or employee of the Administration or of any 
Federal, State, or local agency engaged in enforcement of laws relating 
to controlled substances.

[[Page 13955]]

Sec. 1301.36  Suspension or revocation of registration; suspension of 
registration pending final order; extension of registration pending 
final order.

    (a) For any registration issued under section 303 of the Act (21 
U.S.C. 823), the Administrator may:
    (1) Suspend the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)) for any period of time.
    (2) Revoke the registration pursuant to section 304(a) of the Act 
(21 U.S.C. 824(a)).
    (b) For any registration issued under section 1008 of the Act (21 
U.S.C. 958), the Administrator may:
    (1) Suspend the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) for any period of time.
    (2) Revoke the registration pursuant to section 1008(d) of the Act 
(21 U.S.C. 958(d)) if he/she determines that such registration is 
inconsistent with the public interest as defined in section 1008 or 
with the United States obligations under international treaties, 
conventions, or protocols in effect on October 12, 1984.
    (c) The Administrator may limit the revocation or suspension of a 
registration to the particular controlled substance, or substances, 
with respect to which grounds for revocation or suspension exist.
    (d) Before revoking or suspending any registration, the 
Administrator shall issue an order to show cause pursuant to 
Sec. 1301.37 and, if requested by the registrant, shall hold a hearing 
pursuant to Sec. 1301.41.
    (e) The Administrator may suspend any registration simultaneously 
with or at any time subsequent to the service upon the registrant of an 
order to show cause why such registration should not be revoked or 
suspended, in any case where he/she finds that there is an imminent 
danger to the public health or safety. If the Administrator so 
suspends, he/she shall serve with the order to show cause pursuant to 
Sec. 1301.37 an order of immediate suspension which shall contain a 
statement of his findings regarding the danger to public health or 
safety.
    (f) Upon service of the order of the Administrator suspending or 
revoking registration, the registrant shall immediately deliver his/her 
Certificate of Registration, any order forms, and any import or export 
permits in his/her possession to the nearest office of the 
Administration. The suspension or revocation of a registration shall 
suspend or revoke any individual manufacturing or procurement quota 
fixed for the registrant pursuant to part 1303 of this chapter and any 
import or export permits issued to the registrant pursuant to part 1312 
of this chapter. Also, upon service of the order of the Administrator 
revoking or suspending registration, the registrant shall, as 
instructed by the Administrator:
    (1) Deliver all controlled substances in his/her possession to the 
nearest office of the Administration or to authorized agents of the 
Administration; or
    (2) Place all controlled substances in his/her possession under 
seal as described in sections 304(f) or 1008(d)(6) of the Act (21 
U.S.C. 824(f) or 958(d)(6)).
    (g) In the event that revocation or suspension is limited to a 
particular controlled substance or substances, the registrant shall be 
given a new Certificate of Registration for all substances not affected 
by such revocation or suspension; no fee shall be required to be paid 
for the new Certificate of Registration. The registrant shall deliver 
the old Certificate of Registration and, if appropriate, any order 
forms in his/her possession to the nearest office of the 
Administration. The suspension or revocation of a registration, when 
limited to a particular basic class or classes of controlled 
substances, shall suspend or revoke any individual manufacturing or 
procurement quota fixed for the registrant for such class or classes 
pursuant to part 1303 of this chapter and any import or export permits 
issued to the registrant for such class or classes pursuant to part 
1312 of this chapter. Also, upon service of the order of the 
Administrator revoking or suspending registration, the registrant 
shall, as instructed by the Administrator:
    (1) Deliver to the nearest office of the Administration or to 
authorized agents of the Administration all of the particular 
controlled substance or substances affected by the revocation or 
suspension which are in his/her possession; or
    (2) Place all of such substances under seal as described in 
sections 304(f) or 958(d)(6) of the Act (21 U.S.C. 824(f) or 
958(d)(6)).
    (h) Any suspension shall continue in effect until the conclusion of 
all proceedings upon the revocation or suspension, including any 
judicial review thereof, unless sooner withdrawn by the Administrator 
or dissolved by a court of competent jurisdiction. Any registrant whose 
registration is suspended under paragraph (e) of this section may 
request a hearing on the revocation or suspension of his/her 
registration at a time earlier than specified in the order to show 
cause pursuant to Sec. 1301.37. This request shall be granted by the 
Administrator, who shall fix a date for such hearing as early as 
reasonably possible.
    (i) In the event that an applicant for reregistration (who is doing 
business under a registration previously granted and not revoked or 
suspended) has applied for reregistration at least 45 days before the 
date on which the existing registration is due to expire, and the 
Administrator has issued no order on the application on the date on 
which the existing registration is due to expire, the existing 
registration of the applicant shall automatically be extended and 
continue in effect until the date on which the Administrator so issues 
his/her order. The Administrator may extend any other existing 
registration under the circumstances contemplated in this section even 
though the registrant failed to apply for reregistration at least 45 
days before expiration of the existing registration, with or without 
request by the registrant, if the Administrator finds that such 
extension is not inconsistent with the public health and safety.


Sec. 1301.37  Order to show cause.

    (a) If, upon examination of the application for registration from 
any applicant and other information gathered by the Administration 
regarding the applicant, the Administrator is unable to make the 
determinations required by the applicable provisions of section 303 
and/or section 1008 of the Act (21 U.S.C. 823 and 958) to register the 
applicant, the Administrator shall serve upon the applicant an order to 
show cause why the registration should not be denied.
    (b) If, upon information gathered by the Administration regarding 
any registrant, the Administrator determines that the registration of 
such registrant is subject to suspension or revocation pursuant to 
section 304 or section 1008 of the Act (21 U.S.C. 824 and 958), the 
Administrator shall serve upon the registrant an order to show cause 
why the registration should not be revoked or suspended.
    (c) The order to show cause shall call upon the applicant or 
registrant to appear before the Administrator at a time and place 
stated in the order, which shall not be less than 30 days after the 
date of receipt of the order. The order to show cause shall also 
contain a statement of the legal basis for such hearing and for the 
denial, revocation, or suspension of registration and a summary of the 
matters of fact and law asserted.
    (d) Upon receipt of an order to show cause, the applicant or 
registrant must,

[[Page 13956]]

if he/she desires a hearing, file a request for a hearing pursuant to 
Sec. 1301.43. If a hearing is requested, the Administrator shall hold a 
hearing at the time and place stated in the order, pursuant to 
Sec. 1301.41.
    (e) When authorized by the Administrator, any agent of the 
Administration may serve the order to show cause.

Hearings


Sec. 1301.41  Hearings generally.

    (a) In any case where the Administrator shall hold a hearing on any 
registration or application therefor, the procedures for such hearing 
shall be governed generally by the adjudication procedures set forth in 
the Administrative Procedure Act (5 U.S.C. 551-559) and specifically by 
sections 303, 304, and 1008 of the Act (21 U.S.C. 823-824 and 958), by 
Secs. 1301.42-1301.46 of this part, and by the procedures for 
administrative hearings under the Act set forth in Secs. 1316.41-
1316.67 of this chapter.
    (b) Any hearing under this part shall be independent of, and not in 
lieu of, criminal prosecutions or other proceedings under the Act or 
any other law of the United States.


Sec. 1301.42  Purpose of hearing.

    If requested by a person entitled to a hearing, the Administrator 
shall hold a hearing for the purpose of receiving factual evidence 
regarding the issues involved in the denial, revocation, or suspension 
of any registration, and the granting of any application for 
registration to import or to manufacture in bulk a basic class of 
controlled substance listed in Schedule I or II. Extensive argument 
should not be offered into evidence but rather presented in opening or 
closing statements of counsel or in memoranda or proposed findings of 
fact and conclusions of law.


Sec. 1301.43  Request for hearing or appearance; waiver.

    (a) Any person entitled to a hearing pursuant to Sec. 1301.32 or 
Secs. 1301.34-1301.36 and desiring a hearing shall, within 30 days 
after the date of receipt of the order to show cause (or the date of 
publication of notice of the application for registration in the 
Federal Register in the case of Sec. 1301.34), file with the 
Administrator a written request for a hearing in the form prescribed in 
Sec. 1316.47 of this chapter.
    (b) Any person entitled to participate in a hearing pursuant to 
Sec. 1301.34 or Sec. 1301.35(b) and desiring to do so shall, within 30 
days of the date of publication of notice of the request for a hearing 
in the Federal Register, file with the Administrator a written notice 
of intent to participate in such hearing in the form prescribed in 
Sec. 1316.48 of this chapter. Any person filing a request for a hearing 
need not also file a notice of appearance.
    (c) Any person entitled to a hearing or to participate in a hearing 
pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 may, within the 
period permitted for filing a request for a hearing or a notice of 
appearance, file with the Administrator a waiver of an opportunity for 
a hearing or to participate in a hearing, together with a written 
statement regarding such person's position on the matters of fact and 
law involved in such hearing. Such statement, if admissible, shall be 
made a part of the record and shall be considered in light of the lack 
of opportunity for cross-examination in determining the weight to be 
attached to matters of fact asserted therein.
    (d) If any person entitled to a hearing or to participate in a 
hearing pursuant to Sec. 1301.32 or Secs. 1301.34-1301.36 fails to file 
a request for a hearing or a notice of appearance, or if such person so 
files and fails to appear at the hearing, such person shall be deemed 
to have waived the opportunity for a hearing or to participate in the 
hearing, unless such person shows good cause for such failure.
    (e) If all persons entitled to a hearing or to participate in a 
hearing waive or are deemed to waive their opportunity for the hearing 
or to participate in the hearing, the Administrator may cancel the 
hearing, if scheduled, and issue his/her final order pursuant to 
Sec. 1301.46 without a hearing.


Sec. 1301.44  Burden of proof.

    (a) At any hearing on an application to manufacture any controlled 
substance listed in Schedule I or II, the applicant shall have the 
burden of proving that the requirements for such registration pursuant 
to section 303(a) of the Act (21 U.S.C. 823(a)) are satisfied. Any 
other person participating in the hearing pursuant to Sec. 1301.35(b) 
shall have the burden of proving any propositions of fact or law 
asserted by such person in the hearing.
    (b) At any hearing on the granting or denial of an applicant to be 
registered to conduct a narcotic treatment program or as a compounder, 
the applicant shall have the burden of proving that the requirements 
for each registration pursuant to section 303(g) of the Act (21 U.S.C. 
823(g)) are satisfied.
    (c) At any hearing on the granting or denial of an application to 
be registered to import or export any controlled substance listed in 
Schedule I or II, the applicant shall have the burden of proving that 
the requirements for such registration pursuant to sections 1008(a) and 
(d) of the Act (21 U.S.C. 958 (a) and (d)) are satisfied. Any other 
person participating in the hearing pursuant to Sec. 1301.34 shall have 
the burden of proving any propositions of fact or law asserted by him/
her in the hearings.
    (d) At any other hearing for the denial of a registration, the 
Administration shall have the burden of proving that the requirements 
for such registration pursuant to section 303 or section 1008(c) and 
(d) of the Act (21 U.S.C. 823 or 958(c) and (d)) are not satisfied.
    (e) At any hearing for the revocation or suspension of a 
registration, the Administration shall have the burden of proving that 
the requirements for such revocation or suspension pursuant to section 
304(a) or section 1008(d) of the Act (21 U.S.C. 824(a) or 958(d)) are 
satisfied.


Sec. 1301.45  Time and place of hearing.

    The hearing will commence at the place and time designated in the 
order to show cause or notice of hearing published in the Federal 
Register (unless expedited pursuant to Sec. 1301.36(h)) but thereafter 
it may be moved to a different place and may be continued from day to 
day or recessed to a later day without notice other than announcement 
thereof by the presiding officer at the hearing.


Sec. 1301.46  Final order.

    As soon as practicable after the presiding officer has certified 
the record to the Administrator, the Administrator shall issue his/her 
order on the granting, denial, revocation, or suspension of 
registration. In the event that an application for registration to 
import or to manufacture in bulk a basic class of any controlled 
substance listed in Schedule I or II is granted, or any application for 
registration is denied, or any registration is revoked or suspended, 
the order shall include the findings of fact and conclusions of law 
upon which the order is based. The order shall specify the date on 
which it shall take effect. The Administrator shall serve one copy of 
his/her order upon each party in the hearing.

Modification, Transfer and Termination of Registration


Sec. 1301.51  Modification in registration.

    Any registrant may apply to modify his/her registration to 
authorize the handling of additional controlled substances or to change 
his/her name or address, by submitting a letter of request to the 
Registration Unit, Drug Enforcement Administration,

[[Page 13957]]

Department of Justice, Post Office Box 28083, Central Station, 
Washington, DC 20005. The letter shall contain the registrant's name, 
address, and registration number as printed on the certificate of 
registration, and the substances and/or schedules to be added to his/
her registration or the new name or address and shall be signed in 
accordance with Sec. 1301.13(j). If the registrant is seeking to handle 
additional controlled substances listed in Schedule I for the purpose 
of research or instructional activities, he/she shall attach three 
copies of a research protocol describing each research project 
involving the additional substances, or two copies of a statement 
describing the nature, extent, and duration of such instructional 
activities, as appropriate. No fee shall be required to be paid for the 
modification. The request for modification shall be handled in the same 
manner as an application for registration. If the modification in 
registration is approved, the Administrator shall issue a new 
certificate of registration (DEA Form 223) to the registrant, who shall 
maintain it with the old certificate of registration until expiration.


Sec. 1301.52  Termination of registration; transfer of registration; 
distribution upon discontinuance of business.

    (a) Except as provided in paragraph (b) of this section, the 
registration of any person shall terminate if and when such person 
dies, ceases legal existence, or discontinues business or professional 
practice. Any registrant who ceases legal existence or discontinues 
business or professional practice shall notify the Administrator 
promptly of such fact.
    (b) No registration or any authority conferred thereby shall be 
assigned or otherwise transferred except upon such conditions as the 
Administration may specifically designate and then only pursuant to 
written consent. Any person seeking authority to transfer a 
registration shall submit a written request, providing full details 
regarding the proposed transfer of registration, to the Deputy 
Assistant Administrator, Office of Diversion Control, Drug Enforcement 
Administration, Department of Justice, Washington, DC 20537.
    (c) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substances (without 
transferring such business activities to another person) shall return 
for cancellation his/her certificate of registration, and any 
unexecuted order forms in his/her possession, to the Registration Unit, 
Drug Enforcement Administration, Department of Justice, Post Office Box 
28083, Central Station, Washington, DC 20005. Any controlled substances 
in his/her possession may be disposed of in accordance with 
Sec. 1307.21 of this chapter.
    (d) Any registrant desiring to discontinue business activities 
altogether or with respect to controlled substance (by transferring 
such business activities to another person) shall submit in person or 
by registered or certified mail, return receipt requested, to the 
Special Agent in Charge in his/her area, at least 14 days in advance of 
the date of the proposed transfer (unless the Special Agent in Charge 
waives this time limitation in individual instances), the following 
information:
    (1) The name, address, registration number, and authorized business 
activity of the registrant discontinuing the business (registrant-
transferor);
    (2) The name, address, registration number, and authorized business 
activity of the person acquiring the business (registrant-transferee);
    (3) Whether the business activities will be continued at the 
location registered by the person discontinuing business, or moved to 
another location (if the latter, the address of the new location should 
be listed);
    (4) Whether the registrant-transferor has a quota to manufacture or 
procure any controlled substance listed in Schedule I or II (if so, the 
basic class or class of the substance should be indicated); and
    (5) The date on which the transfer of controlled substances will 
occur.
    (e) Unless the registrant-transferor is informed by the Special 
Agent in Charge, before the date on which the transfer was stated to 
occur, that the transfer may not occur, the registrant-transferor may 
distribute (without being registered to distribute) controlled 
substances in his/her possession to the registrant-transferee in 
accordance with the following:
    (1) On the date of transfer of the controlled substances, a 
complete inventory of all controlled substances being transferred shall 
be taken in accordance with Sec. 1304.11 of this chapter. This 
inventory shall serve as the final inventory of the registrant-
transferor and the initial inventory of the registrant-transferee, and 
a copy of the inventory shall be included in the records of each 
person. It shall not be necessary to file a copy of the inventory with 
the Administration unless requested by the Special Agent in Charge. 
Transfers of any substances listed in Schedule I or II shall require 
the use of order forms in accordance with part 1305 of this chapter.
    (2) On the date of transfer of the controlled substances, all 
records required to be kept by the registrant-transferor with reference 
to the controlled substances being transferred, under part 1304 of this 
chapter, shall be transferred to the registrant-transferee. 
Responsibility for the accuracy of records prior to the date of 
transfer remains with the transferor, but responsibility for custody 
and maintenance shall be upon the transferee.
    (3) In the case of registrants required to make reports pursuant to 
part 1304 of this chapter, a report marked ``Final'' will be prepared 
and submitted by the registrant-transferor showing the disposition of 
all the controlled substances for which a report is required; no 
additional report will be required from him, if no further transactions 
involving controlled substances are consummated by him. The initial 
report of the registrant-transferee shall account for transactions 
beginning with the day next succeeding the date of discontinuance or 
transfer of business by the transferor-registrant and the substances 
transferred to him shall be reported as receipts in his/her initial 
report.
    5. Section 1301.75 is amended by revising paragraph (b) to read as 
follows:


Sec. 1301.75  Physical security controls for practitioners.

* * * * *
    (b) Controlled substances listed in Schedules II, III, IV, and V 
shall be stored in a securely locked, substantially constructed 
cabinet. However, pharmacies and institutional practitioners may 
disperse such substances throughout the stock of noncontrolled 
substances in such a manner as to obstruct the theft or diversion of 
the controlled substances.
* * * * *
    6. Section 1301.76 is amended by revising paragraph (c) to read as 
follows:


Sec. 1301.76  Other security controls for practitioners.

* * * * *
    (c) Whenever the registrant distributes a controlled substance 
(without being registered as a distributor, as permitted in 
Sec. 1301.13(e)(1) and/or Secs. 1307.11-1307.12) he/she shall comply 
with the requirements imposed on nonpractitioners in Sec. 1301.74(a), 
(b), and (e).


Sec. 1301.72  [Amended]

    7. In 21 CFR 1301.72(b)(4)(i)(b) remove the word ``lay'' and add, 
in its place, the word ``lag'.

[[Page 13958]]

PART 1302--[AMENDED]

    1. The authority citation for part 1302 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 825, 871(b), 958 (e).

    2. Section 1302.02 is revised to read as follows:


Sec. 1302.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    3. Section 1302.04 is revised to read as follows:


Sec. 1302.04  Location and size of symbol on label and labeling.

    The symbol shall be prominently located on the label or the 
labeling of the commercial container and/or the panel of the commercial 
container normally displayed to dispensers of any controlled substance. 
The symbol on labels shall be clear and large enough to afford easy 
identification of the schedule of the controlled substance upon 
inspection without removal from the dispenser's shelf. The symbol on 
all other labeling shall be clear and large enough to afford prompt 
identification of the controlled substance upon inspection of the 
labeling.


Sec. 1302.05  [Removed]

    4. Section 1302.05 is removed.
    5. Section 1302.06 is redesignated as Sec. 1302.05 and revised to 
read as follows:


Sec. 1302.05  Effective dates of labeling requirements.

    All labels on commercial containers of, and all labeling of, a 
controlled substance which either is transferred to another schedule or 
is added to any schedule shall comply with the requirements of 
Sec. 1302.03, on or before the effective date established in the final 
order for the transfer or addition.
    6. Section 1302.07 is redesignated as Sec. 1302.06 and revised to 
read as follows:


Sec. 1302.06  Sealing of controlled substances.

    On each bottle, multiple dose vial, or other commercial container 
of any controlled substance, there shall be securely affixed to the 
stopper, cap, lid, covering, or wrapper or such container a seal to 
disclose upon inspection any tampering or opening of the container.
    7. Section 1302.08 is redesignated as Sec. 1302.07 and revised to 
read as follows:


Sec. 1302.07  Labeling and packaging requirements for imported and 
exported substances.

    (a) The symbol requirements of Secs. 1302.03-1302.05 apply to every 
commercial container containing, and to all labeling of, controlled 
substances imported into the jurisdiction of and/or the customs 
territory of the United States.
    (b) The symbol requirements of Secs. 1302.03-1302.05 do not apply 
to any commercial containers containing, or any labeling of, a 
controlled substance intended for export from the jurisdiction of the 
United States.
    (c) The sealing requirements of Sec. 1302.06 apply to every bottle, 
multiple dose vial, or other commercial container of any controlled 
substance listed in schedule I or II, or any narcotic controlled 
substance listed in schedule III or IV, imported into, exported from, 
or intended for export from, the jurisdiction of and/or the customs 
territory of the United States.

PART 1303--[AMENDED]

    1. The authority citation for part 1303 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 826, 871(b).

    2. Section 1303.02 is revised to read as follows:


Sec. 1303.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    3. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
                Section                                Remove                                Add                
----------------------------------------------------------------------------------------------------------------
1303.12(b)............................  (or BND) each place it appears.....                                     
1303.12(b)............................  Drug Control Section...............  Drug & Chemical Evaluation Section.
1303.12(d)............................  Drug Control Section...............  Drug & Chemical Evaluation Section.
1303.12(e)(1).........................  subsance...........................  substance.                         
1303.12(e)(3).........................  1301.22(b).........................  1301.13.                           
1303.21(a)............................  1301.45 and 1301.46................  1301.36.                           
1303.22, introductory text............  (or BND) each place it appears.....                                     
1303.22, introductory text............  Drug Control Section...............  Drug & Chemical Evaluation Section.
1303.26...............................  1301.45 or 1301.46.................  1301.36.                           
1303.27...............................  Drug Control Section...............  Drug & Chemical Evaluation Section.
1303.32(b)............................  1301.45 or 1301.46.................  1301.36.                           
1303.35(a)............................  aggregrate.........................  aggregate.                         
----------------------------------------------------------------------------------------------------------------

PART 1304--[AMENDED]

    1. The authority citation for part 1304 is revised to read as 
follows:

    Authority: 21 U.S.C. 821, 827, 871(b), 958(e), 965, unless 
otherwise noted.

    2. Section 1304.02 is revised to read as follows:


Sec. 1304.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    3. Section 1304.03 is amended by removing paragraphs (g) and (h), 
and revising paragraph (f) to read as follows:


Sec. 1304.03  Persons required to keep records and file reports.

* * * * *
    (f) Registered persons using any controlled substances while 
conducting preclinical research, in teaching at a registered 
establishment which maintains records with respect to such substances 
or conducting research in conformity with an exemption granted under 
section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 355(i) or 360b(j)) at a registered establishment which 
maintains records in accordance with either of those sections, are not 
required to keep records if he/she notifies the Administration of the 
name, address, and registration number of the establishment maintaining 
such records. This notification shall be given at the time the person 
applies for registration or reregistration and shall be made in the 
form of an attachment to the application, which shall be filed with the 
application.
    4. Section 1304.04 is amended by removing ``excuted'' in paragraph 
(a),

[[Page 13959]]

introductory text, and by adding ``executed'' in its place and by 
revising paragraphs (e) and (h) to read as follows:


Sec. 1304.04  Maintenance of records and inventories.

* * * * *
    (e) All central recordkeeping permits previously issued by the 
Administration expired September 30, 1980.
* * * * *
    (h) Each registered pharmacy shall maintain the inventories and 
records of controlled substances as follows:
    (1) Inventories and records of all controlled substances listed in 
Schedules I and II shall be maintained separately from all other 
records of the pharmacy, and prescriptions for such substances shall be 
maintained in a separate prescription file; and
    (2) Inventories and records of controlled substances listed in 
Schedules III, IV, and V shall be maintained either separately from all 
other records of the pharmacy or in such form that the information 
required is readily retrievable from ordinary business records of the 
pharmacy, and prescriptions for such substances shall be maintained 
either in a separate prescription file for controlled substances listed 
in Schedules III, IV, and V only or in such form that they are readily 
retrievable from the other prescription records of the pharmacy. 
Prescriptions will be deemed readily retrievable if, at the time they 
are initially filed, the face of the prescription is stamped in red ink 
in the lower right corner with the letter ``C'' no less than 1 inch 
high and filed either in the prescription file for controlled 
substances listed in Schedules I and II or in the usual consecutively 
numbered prescription file for non-controlled substances. However, if a 
pharmacy employs an ADP system or other electronic recordkeeping system 
for prescriptions which permits identification by prescription number 
and retrieval of original documents by prescriber's name, patient's 
name, drug dispensed, and date filled, then the requirement to mark the 
hard copy prescription with a red ``C'' is waived.
    5. Section 1304.11 is revised to read as follows:


Sec. 1304.11  Inventory requirements.

    (a) General requirements. Each inventory shall contain a complete 
and accurate record of all controlled substances on hand on the date 
the inventory is taken, and shall be maintained in written, 
typewritten, or printed form at the registered location. An inventory 
taken by use of an oral recording device must be promptly transcribed. 
Controlled substances shall be deemed to be ``on hand'' if they are in 
the possession of or under the control of the registrant, including 
substances returned by a customer, ordered by a customer but not yet 
invoiced, stored in a warehouse on behalf of the registrant, and 
substances in the possession of employees of the registrant and 
intended for distribution as complimentary samples. A separate 
inventory shall be made for each registered location and each 
independent activity registered, except as provided in paragraph (e)(4) 
of this section. In the event controlled substances in the possession 
or under the control of the registrant are stored at a location for 
which he/she is not registered, the substances shall be included in the 
inventory of the registered location to which they are subject to 
control or to which the person possessing the substance is responsible. 
The inventory may be taken either as of opening of business or as of 
the close of business on the inventory date and it shall be indicated 
on the inventory.
    (b) Initial inventory date. Every person required to keep records 
shall take an inventory of all stocks of controlled substances on hand 
on the date he/she first engages in the manufacture, distribution, or 
dispensing of controlled substances, in accordance with paragraph (e) 
of this section as applicable. In the event a person commences business 
with no controlled substances on hand, he/she shall record this fact as 
the initial inventory.
    (c) Biennial inventory date. After the initial inventory is taken, 
the registrant shall take a new inventory of all stocks of controlled 
substances on hand at least every two years. The biennial inventory may 
be taken on any date which is within two years of the previous biennial 
inventory date.
    (d) Inventory date for newly controlled substances. On the 
effective date of a rule by the Administrator pursuant to 
Secs. 1308.45, 1308.46, or 1308.47 of this chapter adding a substance 
to any schedule of controlled substances, which substance was, 
immediately prior to that date, not listed on any such schedule, every 
registrant required to keep records who possesses that substance shall 
take an inventory of all stocks of the substance on hand. Thereafter, 
such substance shall be included in each inventory made by the 
registrant pursuant to paragraph (c) of this section.
    (e) Inventories of manufacturers, distributors, dispensers, 
researchers, importers, exporters and chemical analysts. Each person 
registered or authorized (by Sec. 1301.13 or Secs. 1307.11-1307.13 of 
this chapter) to manufacture, distribute, dispense, import, export, 
conduct research or chemical analysis with controlled substances and 
required to keep records pursuant to Sec. 1304.03 shall include in the 
inventory the information listed below.
    (1) Inventories of manufacturers. Each person registered or 
authorized to manufacture controlled substances shall include the 
following information in the inventory:
    (i) For each controlled substance in bulk form to be used in (or 
capable of use in) the manufacture of the same or other controlled or 
non-controlled substances in finished form, the inventory shall 
include:
    (A) The name of the substance and
    (B) The total quantity of the substance to the nearest metric unit 
weight consistent with unit size.
    (ii) For each controlled substance in the process of manufacture on 
the inventory date, the inventory shall include:
    (A) The name of the substance;
    (B) The quantity of the substance in each batch and/or stage of 
manufacture, identified by the batch number or other appropriate 
identifying number; and
    (C) The physical form which the substance is to take upon 
completion of the manufacturing process (e.g., granulations, tablets, 
capsules, or solutions), identified by the batch number or other 
appropriate identifying number, and if possible the finished form of 
the substance (e.g., 10-milligram tablet or 10-milligram concentration 
per fluid ounce or milliliter) and the number or volume thereof.
    (iii) For each controlled substance in finished form the inventory 
shall include:
    (A) The name of the substance;
    (B) Each finished form of the substance (e.g., 10-milligram tablet 
or 10-milligram concentration per fluid ounce or milliliter);
    (C) The number of units or volume of each finished form in each 
commercial container (e.g., 100-tablet bottle or 3-milliliter vial); 
and
    (D) The number of commercial containers of each such finished form 
(e.g. four 100-tablet bottles or six 3-milliliter vials).
    (iv) For each controlled substance not included in paragraphs 
(e)(1) (i), (ii) or (iii) of this section (e.g., damaged, defective or 
impure substances awaiting disposal, substances held for quality 
control purposes, or substances maintained for extemporaneous 
compoundings) the inventories shall include:
    (A) The name of the substance;
    (B) The total quantity of the substance to the nearest metric unit 
weight or the

[[Page 13960]]

total number of units of finished form; and
    (C) The reason for the substance being maintained by the registrant 
and whether such substance is capable of use in the manufacture of any 
controlled substance in finished form.
    (2) Inventories of distributors. Each person registered or 
authorized to distribute controlled substances shall include in the 
inventory the same information required of manufacturers pursuant to 
paragraphs (e)(1) (iii) and (iv) of this section.
    (3) Inventories of dispensers and researchers. Each person 
registered or authorized to dispense or conduct research with 
controlled substances shall include in the inventory the same 
information required of manufacturers pursuant to paragraphs (e)(1) 
(iii) and (iv) of this section. In determining the number of units of 
each finished form of a controlled substance in a commercial container 
which has been opened, the dispenser shall do as follows:
    (i) If the substance is listed in Schedule I or II, make an exact 
count or measure of the contents, or
    (ii) If the substance is listed in Schedule III, IV or V, make an 
estimated count or measure of the contents, unless the container holds 
more than 1,000 tablets or capsules in which case he/she must make an 
exact count of the contents.
    (4) Inventories of importers and exporters. Each person registered 
or authorized to import or export controlled substances shall include 
in the inventory the same information required of manufacturers 
pursuant to paragraphs (e)(1) (iii) and (iv) of this section. Each such 
person who is also registered as a manufacturer or as a distributor 
shall include in his/her inventory as an importer or exporter only 
those stocks of controlled substances that are actually separated from 
his stocks as a manufacturer or as a distributor (e.g., in transit or 
in storage for shipment).
    (5) Inventories of chemical analysts. Each person registered or 
authorized to conduct chemical analysis with controlled substances 
shall include in his inventory the same information required of 
manufacturers pursuant to paragraphs (e)(1) (iii) and (iv) of this 
section as to substances which have been manufactured, imported, or 
received by such person. If less than 1 kilogram of any controlled 
substance (other than a hallucinogenic controlled substance listed in 
Schedule I), or less than 20 grams of a hallucinogenic substance listed 
in Schedule I (other than lysergic acid diethylamide), or less than 0.5 
gram of lysergic acid diethylamide, is on hand at the time of 
inventory, that substance need not be included in the inventory. 
Laboratories of the Administration may possess up to 150 grams of any 
hallucinogenic substance in Schedule I without regard to a need for an 
inventory of those substances. No inventory is required of known or 
suspected controlled substances received as evidentiary materials for 
analysis.


Secs. 1304.12-1304.19  [Removed]

    6. Sections 1304.12, 1304.13, 1304.14, 1304.15, 1304.16, 1304.17, 
1304.18 and 1304.19 are removed.
    7. Section 1304.21 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec. 1304.21  General requirements for continuing records.

    (a) Every registrant required to keep records pursuant to 
Sec. 1304.03 shall maintain on a current basis a complete and accurate 
record of each such substance manufactured, imported, received, sold, 
delivered, exported, or otherwise disposed of by him/her, except that 
no registrant shall be required to maintain a perpetual inventory.
    (b) * * *
    (c) Separate records shall be maintained by a registrant for each 
independent activity for which he/she is registered, except as provided 
in Sec. 1304.22(d).
* * * * *
    8. Section 1304.22 is revised to read as follows:


Sec. 1304.22  Records for manufacturers, distributors, dispensers, 
researchers, importers and exporters.

    Each person registered or authorized (by Sec. 1301.13(e) or 
Secs. 1307.11-1307.13 of this chapter) to manufacture, distribute, 
dispense, import, export or conduct research with controlled substances 
shall maintain records with the information listed below.
    (a) Records for manufacturers. Each person registered or authorized 
to manufacture controlled substances shall maintain records with the 
following information:
    (1) For each controlled substance in bulk form to be used in, or 
capable of use in, or being used in, the manufacture of the same or 
other controlled or noncontrolled substances in finished form,
    (i) The name of the substance;
    (ii) The quantity manufactured in bulk form by the registrant, 
including the date, quantity and batch or other identifying number of 
each batch manufactured;
    (iii) The quantity received from other persons, including the date 
and quantity of each receipt and the name, address, and registration 
number of the other person from whom the substance was received;
    (iv) The quantity imported directly by the registrant (under a 
registration as an importer) for use in manufacture by him/her, 
including the date, quantity, and import permit or declaration number 
for each importation;
    (v) The quantity used to manufacture the same substance in finished 
form, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The quantity used in the manufacture;
    (C) The finished form (e.g., 10-milligram tablets or 10-milligram 
concentration per fluid ounce or milliliter);
    (D) The number of units of finished form manufactured;
    (E) The quantity used in quality control;
    (F) The quantity lost during manufacturing and the causes 
therefore, if known;
    (G) The total quantity of the substance contained in the finished 
form;
    (H) The theoretical and actual yields; and
    (I) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vi) The quantity used to manufacture other controlled and 
noncontrolled substances, including the name of each substance 
manufactured and the information required in paragraph (a)(1)(v) of 
this section;
    (vii) The quantity distributed in bulk form to other persons, 
including the date and quantity of each distribution and the name, 
address, and registration number of each person to whom a distribution 
was made;
    (viii) The quantity exported directly by the registrant (under a 
registration as an exporter), including the date, quantity, and export 
permit or declaration number of each exportation;
    (ix) The quantity distributed or disposed of in any other manner by 
the registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or 
disposal, the name, address, and registration number of the person to 
whom distributed, and the quantity distributed or disposed; and
    (x) The originals of all written certifications of available 
procurement quotas submitted by other persons (as

[[Page 13961]]

required by Sec. 1303.12(f) of this chapter) relating to each order 
requiring the distribution of a basic class of controlled substance 
listed in Schedule I or II.
    (2) For each controlled substance in finished form,
    (i) The name of the substance;
    (ii) Each finished form (e.g., 10-milligram tablet or 10-milligram 
concentration per fluid ounce or milliliter) and the number of units or 
volume of finished form in each commercial container (e.g., 100-tablet 
bottle or 3-milliliter vial);
    (iii) The number of containers of each such commercial finished 
form manufactured from bulk form by the registrant, including the 
information required pursuant to paragraph (a)(1)(v) of this section;
    (iv) The number of units of finished forms and/or commercial 
containers acquired from other persons, including the date of and 
number of units and/or commercial containers in each acquisition to 
inventory and the name, address, and registration number of the person 
from whom the units were acquired;
    (v) The number of units of finished forms and/or commercial 
containers imported directly by the person (under a registration or 
authorization to import), including the date of, the number of units 
and/or commercial containers in, and the import permit or declaration 
number for, each importation;
    (vi) The number of units and/or commercial containers manufactured 
by the registrant from units in finished form received from others or 
imported, including:
    (A) The date and batch or other identifying number of each 
manufacture;
    (B) The operation performed (e.g., repackaging or relabeling);
    (C) The number of units of finished form used in the manufacture, 
the number manufactured and the number lost during manufacture, with 
the causes for such losses, if known; and
    (D) Such other information as is necessary to account for all 
controlled substances used in the manufacturing process;
    (vii) The number of commercial containers distributed to other 
persons, including the date of and number of containers in each 
reduction from inventory, and the name, address, and registration 
number of the person to whom the containers were distributed; (viii) 
The number of commercial containers exported directly by the registrant 
(under a registration as an exporter), including the date, number of 
containers and export permit or declaration number for each 
exportation; and
    (ix) The number of units of finished forms and/or commercial 
containers distributed or disposed of in any other manner by the 
registrant (e.g., by distribution of complimentary samples or by 
destruction), including the date and manner of distribution or 
disposal, the name, address, and registration number of the person to 
whom distributed, and the quantity in finished form distributed or 
disposed.
    (b) Records for distributors. Each person registered or authorized 
to distribute controlled substances shall maintain records with the 
same information required of manufacturers pursuant to paragraphs 
(a)(2) (i), (ii), (iv), (v), (vii), (viii) and (ix) of this section.
    (c) Records for dispensers and researchers. Each person registered 
or authorized to dispense or conduct research with controlled 
substances shall maintain records with the same information required of 
manufacturers pursuant to paragraph (a)(2) (i), (ii), (iv), (vii), and 
(ix) of this section. In addition, records shall be maintained of the 
number of units or volume of such finished form dispensed, including 
the name and address of the person to whom it was dispensed, the date 
of dispensing, the number of units or volume dispensed, and the written 
or typewritten name or initials of the individual who dispensed or 
administered the substance on behalf of the dispenser.
    (d) Records for importers and exporters. Each person registered or 
authorized to import or export controlled substances shall maintain 
records with the same information required of manufacturers pursuant to 
paragraphs (a)(2) (i), (iv), (v) and (vii) of this section. In 
addition, the quantity disposed of in any other manner by the 
registrant (except quantities used in manufacturing by an importer 
under a registration as a manufacturer), which quantities are to be 
recorded pursuant to paragraphs (a)(1) (iv) and (v) of this section; 
and the quantity (or number of units or volume in finished form) 
exported, including the date, quantity (or number of units or volume), 
and the export permit or declaration number for each exportation, but 
excluding all quantities (and number of units and volumes) manufactured 
by an exporter under a registration as a manufacturer, which quantities 
(and numbers of units and volumes) are to be recorded pursuant to 
paragraphs (a)(1)(xiii) or (a)(2)(xiii) of this section.


Sec. 1304.23-1304.26  [Removed]

    9. Sections 1304.23 through 1304.26 are removed.


Sec. 1304.27  [Redesignated as Sec. 1304.23]

    10. Section 1304.27 is redesignated as Sec. 1304.23.


Sec. 1304.28  [Redesignated as Sec. 1304.24 and amended]

    11. Section 1304.28 is redesignated as Sec. 1304.24 and reference 
in Sec. 1304.28(b) to ``Sec. 1304.24'' is revised to read 
``Sec. 1304.22'', and in paragraph (d), the words ``part 1401 of this 
title'' are revised to read ``42 CFR Part 2.''


Sec. 1304.29  [Redesignated as Sec. 1304.25]

    12. Section 1304.29 is redesignated as Sec. 1304.25.
    13. Section 1304.31 is revised to read as follows:


Sec. 1304.31  Reports from manufacturers importing narcotic raw 
material.

    (a) Every manufacturer which imports or manufactures from narcotic 
raw material (opium, poppy straw, and concentrate of poppy straw) shall 
submit information which accounts for the importation and for all 
manufacturing operations performed between importation and the 
production in bulk or finished marketable products, standardized in 
accordance with the U.S. Pharmacopeia, National Formulary or other 
recognized medical standards. Reports shall be signed by the authorized 
official and submitted quarterly on company letterhead to the Drug 
Enforcement Administration, Drug and Chemical Evaluation Section, 
Washington, D.C. 20537, on or before the 15th day of the month 
immediately following the period for which it is submitted.
    (b) The following information shall be submitted for each type of 
narcotic raw material (quantities are expressed as grams of anhydrous 
morphine alkaloid):
    (1) Beginning inventory;
    (2) Gains on reweighing;
    (3) Imports;
    (4) Other receipts;
    (5) Quantity put into process;
    (6) Losses on reweighing;
    (7) Other dispositions and
    (8) Ending inventory.
    (c) The following information shall be submitted for each narcotic 
raw material derivative including morphine, codeine, thebaine, 
oxycodone, hydrocodone, medicinal opium, manufacturing opium, crude 
alkaloids and other derivatives (quantities are expressed as grams of 
anhydrous base or anhydrous morphine alkaloid for manufacturing opium 
and medicinal opium):
    (1) Beginning inventory;
    (2) Gains on reweighing;

[[Page 13962]]

    (3) Quantity extracted from narcotic raw material;
    (4) Quantity produced/manufactured/synthesized;
    (5) Quantity sold;
    (6) Quantity returned to conversion processes for reworking;
    (7) Quantity used for conversion;
    (8) Quantity placed in process;
    (9) Other dispositions;
    (10) Losses on reweighing and
    (11) Ending inventory.
    (d) The following information shall be submitted for importation of 
each narcotic raw material:
    (1) Import permit number;
    (2) Date shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of morphine, codeine and thebaine and
    (5) Quantity shipped, expressed as anhydrous morphine alkaloid.
    (e) Upon importation of crude opium, samples will be selected and 
assays made by the importing manufacturer in the manner and according 
to the method specified in the U.S. Pharmacopoeia. Where final assay 
data is not determined at the time of rendering report, the report 
shall be made on the basis of the best data available, subject to 
adjustment, and the necessary adjusting entries shall be made on the 
next report.
    (f) Where factory procedure is such that partial withdrawals of 
opium are made from individual containers, there shall be attached to 
each container a stock record card on which shall be kept a complete 
record of all withdrawals therefrom.
    (g) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed 
or placed into process for the manufacture of a specified end-product, 
it must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.
    14. Section 1304.32 is revised to read as follows:


Sec. 1304.32  Reports of manufacturers importing coca leaves.

    (a) Every manufacturer importing or manufacturing from raw coca 
leaves shall submit information accounting for the importation and for 
all manufacturing operations performed between the importation and the 
manufacture of bulk or finished products standardized in accordance 
with U.S. Pharmacopoeia, National Formulary, or other recognized 
standards. The reports shall be submitted quarterly on company 
letterhead to the Drug Enforcement Administration, Drug and Chemical 
Evaluation Section, Washington, DC 20537, on or before the 15th day of 
the month immediately following the period for which it is submitted.
    (b) The following information shall be submitted for raw coca leaf, 
ecgonine, ecgonine for conversion or further manufacture, 
benzoylecgonine, manufacturing coca extracts (list for tinctures and 
extracts; and others separately), other crude alkaloids and other 
derivatives (quantities should be reported as grams of actual quantity 
involved and the cocaine alkaloid content or equivalency):
    (1) Beginning inventory;
    (2) Imports;
    (3) Gains on reweighing;
    (4) Quantity purchased;
    (5) Quantity produced;
    (6) Other receipts;
    (7) Quantity returned to processes for reworking;
    (8) Material used in purification for sale;
    (9) Material used for manufacture or production;
    (10) Losses on reweighing;
    (11) Material used for conversion;
    (12) Other dispositions and
    (13) Ending inventory.
    (c) The following information shall be submitted for importation of 
coca leaves:
    (1) Import permit number;
    (2) Date the shipment arrived at the United States port of entry;
    (3) Actual quantity shipped;
    (4) Assay (percent) of cocaine alkaloid and
    (5) Total cocaine alkaloid content.
    (d) Upon importation of coca leaves, samples will be selected and 
assays made by the importing manufacturer in accordance with recognized 
chemical procedures. These assays shall form the basis of accounting 
for such coca leaves, which shall be accounted for in terms of their 
cocaine alkaloid content or equivalency or their total anhydrous coca 
alkaloid content. Where final assay data is not determined at the time 
of submission, the report shall be made on the basis of the best data 
available, subject to adjustment, and the necessary adjusting entries 
shall be made on the next report.
    (e) Where factory procedure is such that partial withdrawals of 
medicinal coca leaves are made from individual containers, there shall 
be attached to the container a stock record card on which shall be kept 
a complete record of withdrawals therefrom.
    (f) All in-process inventories should be expressed in terms of end-
products and not precursors. Once precursor material has been changed 
or placed into process for the manufacture of a specified end-product, 
it must no longer be accounted for as precursor stocks available for 
conversion or use, but rather as end-product in-process inventories.


Sec. 1304.33  [Removed]

    15. Section 1304.33 is removed.


Sec. 1304.34  [Redesignated as Sec. 1304.33 and reviewes]

    16. Section 1304.34 is redesignated as Sec. 1304.33 and revised to 
read as follows:


Sec. 1304.33  Reports to ARCOS.

    (a) Reports generally. All reports required by this section shall 
be filed with the ARCOS Unit, PO 28293, Central Station, Washington, DC 
20005 on DEA Form 333, or on media which contains the data required by 
DEA Form 333 and which is acceptable to the ARCOS Unit.
    (b) Frequency of reports. Acquisition/Distribution transaction 
reports shall be filed every quarter not later than the 15th day of the 
month succeeding the quarter for which it is submitted; except that a 
registrant may be given permission to file more frequently (but not 
more frequently than monthly), depending on the number of transactions 
being reported each time by that registrant. Inventories shall provide 
data on the stocks of each reported controlled substance on hand as of 
the close of business on December 31 of each year, indicating whether 
the substance is in storage or in process of manufacturing. These 
reports shall be filed not later than January 15 of the following year. 
Manufacturing transaction reports shall be filed annually for each 
calendar year not later than January 15 of the following year, except 
that a registrant may be given permission to file more frequently (but 
not more frequently than quarterly).
    (c) Persons reporting. For controlled substances in Schedules I, II 
or narcotic controlled substances in Schedule III, each person who is 
registered to manufacture in bulk or dosage form, or to package, 
repackage, label or relabel, and each person who is registered to 
distribute shall report acquisition/distribution transactions. In 
addition to reporting acquisition/distribution transactions, each 
person who is registered to manufacture controlled substances in bulk 
or dosage form shall report manufacturing transactions on controlled 
substances in Schedules I and II, each narcotic controlled substance 
listed in Schedules III, IV, and V, and on each psychotropic controlled 
substance listed in Schedules

[[Page 13963]]

III and IV as identified in paragraph (d) of this section.
    (d) Substances covered.  (1) Manufacturing and acquisition/
distribution transaction reports shall include data on each controlled 
substance listed in Schedules I and II and on each narcotic controlled 
substance listed in Schedule III (but not on any material, compound, 
mixture or preparation containing a quantity of a substance having a 
stimulant effect on the central nervous system, which material, 
compound, mixture or preparation is listed in Schedule III or on any 
narcotic controlled substance listed in Schedule V). Additionally, 
reports on manufacturing transactions shall include the following 
psychotropic controlled substances listed in Schedules III and IV:
    (i) Schedule III
    (A) Benzphetamine;
    (B) Cyclobarbital;
    (C) Methyprylon; and
    (D) Phendimetrazine.
    (ii) Schedule IV
    (A) Barbital;
    (B) Diethylpropion (Amfepramone);
    (C) Ethchlorvynol;
    (D) Ethinamate;
    (E) Lefetamine (SPA);
    (F) Mazindol;
    (G) Meprobamate;
    (H) Methylphenobarbital;
    (I) Phenobarbital;
    (J) Phentermine; and
    (K) Pipradrol.
    (2) Data shall be presented in such a manner as to identify the 
particular form, strength, and trade name, if any, of the product 
containing the controlled substance for which the report is being made. 
For this purpose, persons filing reports shall utilize the National 
Drug Code Number assigned to the product under the National Drug Code 
System of the Food and Drug Administration.
    (e) Transactions reported. Acquisition/distribution transaction 
reports shall provide data on each acquisition to inventory 
(identifying whether it is, e.g., by purchase or transfer, return from 
a customer, or supply by the Federal Government) and each reduction 
from inventory (identifying whether it is, e.g., by sale or transfer, 
theft, destruction or seizure by Government agencies). Manufacturing 
reports shall provide data on material manufactured, manufacture from 
other material, use in manufacturing other material and use in 
producing dosage forms.
    (f) Exceptions. A registered institutional practitioner who 
repackages or relabels exclusively for distribution or who distributes 
exclusively to (for dispensing by) agents, employees, or affiliated 
institutional practitioners of the registrant may be exempted from 
filing reports under this section by applying to the ARCOS Unit of the 
Administration.

(Approved by the Office of Management and Budget under control 
number 1117-0003)


Secs. 1304.35-1304.38  [Removed]

    17. Sections 1304.35 through 1304.38 are removed.

PART 1305--[AMENDED]

    1. The authority citation for part 1305 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 828, 871(b) unless otherwise noted.

    2. Section 1305.02 is revised to read as follows:


Sec. 1305.02   Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    3. Section 1305.03 is revised to read as follows:


Sec. 1305.03  Distributions requiring order forms.

    An order form (DEA Form 222) is required for each distribution of a 
Schedule I or II controlled substance except to persons exempted from 
registration under part 1301 of this chapter; which are exported from 
the United States in conformity with the Act; or for delivery to a 
registered analytical laboratory, or its agent approved by DEA.
    4. Section 1305.06 is revised to read as follows:


Sec. 1305.06  Procedure for executing order forms.

    (a) Order forms shall be prepared and executed by the purchaser 
simultaneously in triplicate by means of interleaved carbon sheets 
which are part of the DEA Form 222. Order forms shall be prepared by 
use of a typewriter, pen, or indelible pencil.
    (b) Only one item shall be entered on each numbered line. An item 
shall consist of one or more commercial or bulk containers of the same 
finished or bulk form and quantity of the same substance. The number of 
lines completed shall be noted on that form at the bottom of the form, 
in the space provided. Order forms for carfentanil, etorphine 
hydrochloride, and diprenorphine shall contain only these substances.
    (c) The name and address of the supplier from whom the controlled 
substances are being ordered shall be entered on the form. Only one 
supplier may be listed on any form.
    (d) Each order form shall be signed and dated by a person 
authorized to sign an application for registration. The name of the 
purchaser, if different from the individual signing the order form, 
shall also be inserted in the signature space. Unexecuted order forms 
may be kept and may be executed at a location other than the registered 
location printed on the form, provided that all unexecuted forms are 
delivered promptly to the registered location upon an inspection of 
such location by any officer authorized to make inspections, or to 
enforce, any Federal, State, or local law regarding controlled 
substances.
    5. Section 1305.07 is revised to read as follows:


Sec. 1305.07  Power of attorney.

    Any purchaser may authorize one or more individuals, whether or not 
located at the registered location of the purchaser, to obtain and 
execute order forms on his/her behalf by executing a power of attorney 
for each such individual. The power of attorney shall be signed by the 
same person who signed the most recent application for registration or 
reregistration and by the individual being authorized to obtain and 
execute order forms. The power of attorney shall be filed with the 
executed order forms of the purchaser, and shall be retained for the 
same period as any order form bearing the signature of the attorney. 
The power of attorney shall be available for inspection together with 
other order form records. Any power of attorney may be revoked at any 
time by executing a notice of revocation, signed by the person who 
signed (or was authorized to sign) the power of attorney or by a 
successor, whoever signed the most recent application for registration 
or reregistration, and filing it with the power of attorney being 
revoked. The form for the power of attorney and notice of revocation 
shall be similar to the following:

Power of Attorney for DEA Order Forms

__________ (Name of registrant)
__________ (Address of registrant)
__________ (DEA registration number)

    I, __________ (name of person granting power), the undersigned, 
who is authorized to sign the current application for registration 
of the above-named registrant under the Controlled Substances Act or 
Controlled Substances Import and Export Act, have made, constituted, 
and appointed, and by these presents, do make, constitute, and 
appoint __________ (name of attorney-in-fact), my true and lawful 
attorney for me in my name, place, and stead, to execute 
applications for books of official order forms and to sign such 
order forms in requisition for Schedule I and II controlled 
substances, in accordance with section 308 of the Controlled 
Substances Act (21 U.S.C. 828)

[[Page 13964]]

and part 1305 of Title 21 of the Code of Federal Regulations. I 
hereby ratify and confirm all that said attorney shall lawfully do 
or cause to be done by virtue hereof.

----------------------------------------------------------------------
(Signature of person granting power)

    I, __________ (name of attorney-in-fact), hereby affirm that I 
am the person named herein as attorney-in-fact and that the 
signature affixed hereto is my signature.

----------------------------------------------------------------------
(Signature of attorney-in-fact)

    Witnesses:
    1. __________.
    2. __________.
    Signed and dated on the ______ day of __________, (year), at 
__________.

Notice of Revocation

    The foregoing power of attorney is hereby revoked by the 
undersigned, who is authorized to sign the current application for 
registration of the above-named registrant under the Controlled 
Substances Act of the Controlled Substances Import and Export Act. 
Written notice of this revocation has been given to the attorney-in-
fact __________ this same day.

----------------------------------------------------------------------
(Signature of person revoking power)
    Witnesses:
    1. __________.
    2. __________.
    Signed and dated on the ______ day of __________, (year), at 
__________.

    6. Section 1305.12 is amended by revising paragraph (b) to read as 
follows:


Sec. 1305.12  Lost or stolen order forms.

* * * * *
    (b) Whenever any used or unused order forms are stolen or lost 
(otherwise than in the course of transmission) by any purchaser or 
supplier, he/she shall immediately upon discovery of such theft or 
loss, report the same to the Special Agent in Charge of the Drug 
Enforcement Administration in the Divisional Office responsible for the 
area in which the registrant is located, stating the serial number of 
each form stolen or lost. If the theft or loss includes any original 
order forms received from purchasers and the supplier is unable to 
state the serial numbers of such order forms, he/she shall report the 
date or approximate date of receipt thereof and the names and addresses 
of the purchasers. If an entire book of order forms is lost or stolen, 
and the purchaser is unable to state the serial numbers of the order 
forms contained therein, he/she shall report, in lieu of the numbers of 
the forms contained in such book, the date or approximate date of 
issuance thereof. If any unused order form reported stolen or lost is 
subsequently recovered or found, the Special Agent in Charge of the 
Drug Enforcement Administration in the Divisional Office responsible 
for the area in which the registrant is located shall immediately be 
notified.
    7. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
                 Section                                  Remove                               Add              
----------------------------------------------------------------------------------------------------------------
1305.04(b)..............................  his..................................  his/her                        
1305.05(b)..............................  him (twice)..........................  him/her                        
1305.08(a)..............................  he...................................  he/she                         
1305.08(a)..............................  his (twice)..........................  his/her                        
1305.09(b)..............................  he...................................  he/she                         
1305.09(d)..............................  his ovn..............................  his/her own                    
1305.10(a)..............................  hall.................................  shall                          
1305.10(a)..............................  he...................................  he/she                         
1305.13(a)..............................  He...................................  He/She                         
1305.13(b)..............................  he...................................  he/she                         
1305.13(c)..............................  he...................................  he/she                         
1305.13(c)..............................  1305.06(e)...........................  1305.06(d)                     
1305.14.................................  he (twice)...........................  he/she                         
1305.14.................................  1301.45 or 1301.46...................  1301.36                        
1305.16(b)..............................  he...................................  he/she                         
----------------------------------------------------------------------------------------------------------------

PART 1306--[AMENDED]

    1. The authority citation for part 1306 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 829, 871(b).

    2. Section 1306.02 is revised to read as follows:


Sec. 1306.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.
    3. Section 1306.11 is amended by revising paragraphs (a),(d)(4), 
and (e), and adding a new paragraph (g) to read as follows:


Sec. 1306.11  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance 
listed in Schedule II, which is a prescription drug as determined under 
the Federal Food, Drug, and Cosmetic Act, only pursuant to a written 
prescription signed by the practitioner, except as provided in 
paragraph (d) of this section. A prescription for a Schedule II 
controlled substance may be transmitted by the practitioner or the 
practitioner's agent to a pharmacy via facsimile equipment, provided 
that the original written, signed prescription is presented to the 
pharmacist for review prior to the actual dispensing of the controlled 
substance, except as noted in paragraph (e), (f), or (g) of this 
section. The original prescription shall be maintained in accordance 
with Sec. 1304.04(h) of this chapter.
* * * * *
    (d) * * *
    (4) Within 7 days after authorizing an emergency oral prescription, 
the prescribing individual practitioner shall cause a written 
prescription for the emergency quantity prescribed to be delivered to 
the dispensing pharmacist. In addition to conforming to the 
requirements of Sec. 1306.05, the prescription shall have written on 
its face ``Authorization for Emergency Dispensing,'' and the date of 
the oral order. The written prescription may be delivered to the 
pharmacist in person or by mail, but if delivered by mail it must be 
postmarked within the 7 day period. Upon receipt, the dispensing 
pharmacist shall attach this prescription to the oral emergency 
prescription which had earlier been reduced to writing. The pharmacist 
shall notify the nearest office of the Administration if the 
prescribing individual practitioner fails to deliver a written 
prescription to him; failure of the pharmacist to do so shall void the 
authority conferred by this paragraph to dispense without a written 
prescription of a prescribing individual practitioner.
    (e) A prescription prepared in accordance with Sec. 1306.05 written 
for a

[[Page 13965]]

Schedule II narcotic substance to be compounded for the direct 
administration to a patient by parenteral, intravenous, intramuscular, 
subcutaneous or intraspinal infusion may be transmitted by the 
practitioner or the practitioner's agent to the pharmacy by facsimile. 
The facsimile serves as the original written prescription for purposes 
of this paragraph (e) and it shall be maintained in accordance with 
Sec. 1304.04(h) of this chapter.
* * * * *
    (g) A prescription prepared in accordance with Sec. 1306.05 written 
for a Schedule II narcotic substance for a patient residing in a 
hospice certified by Medicare under Title XVIII or licensed by the 
state may be transmitted by the practitioner or the practitioner's 
agent to the dispensing pharmacy by facsimile. The practitioner or the 
practitioner's agent will note on the prescription that the patient is 
a hospice patient. The facsimile serves as the original written 
prescription for purposes of this paragraph (g) and it shall be 
maintained in accordance with Sec. 1304.04(h) of this chapter.
    4. Section 1306.13 is amended by revising paragraph (b) to read as 
follows:


Sec. 1306.13  Partial filling of prescriptions.

* * * * *
    (b) A prescription for a Schedule II controlled substance written 
for a patient in a Long Term Care Facility (LTCF) or for a patient with 
a medical diagnosis documenting a terminal illness may be filled in 
partial quantities to include individual dosage units. If there is any 
question whether a patient may be classified as having a terminal 
illness, the pharmacist must contact the practitioner prior to 
partially filling the prescription. Both the pharmacist and the 
prescribing practitioner have a corresponding responsibility to assure 
that the controlled substance is for a terminally ill patient. The 
pharmacist must record on the prescription whether the patient is 
``terminally ill'' or an ``LTCF patient.'' A prescription that is 
partially filled and does not contain the notation ``terminally ill'' 
or ``LTCF patient'' shall be deemed to have been filled in violation of 
the Act. For each partial filling, the dispensing pharmacist shall 
record on the back of the prescription (or on another appropriate 
record, uniformly maintained, and readily retrievable) the date of the 
partial filling, quantity dispensed, remaining quantity authorized to 
be dispensed, and the identification of the dispensing pharmacist. The 
total quantity of Schedule II controlled substances dispensed in all 
partial fillings must not exceed the total quantity prescribed. 
Schedule II prescriptions for patients in a LTCF or patients with a 
medical diagnosis documenting a terminal illness shall be valid for a 
period not to exceed 60 days from the issue date unless sooner 
terminated by the discontinuance of medication.
* * * * *
    5. Section 1306.14 is amended by revising the heading and adding a 
new paragraph (c) to read as follows:


Sec. 1306.14  Labeling of substances and filing of prescriptions.

* * * * *
    (c) All written prescriptions and written records of emergency oral 
prescriptions shall be kept in accordance with requirements of 
Sec. 1304.04(h) of this chapter.


Sec. 1306.15  [Removed]

    6. Section 1306.15 is removed.
    7. The center undesignated heading preceding Sec. 1306.21 and 
Sec. 1306.21 are revised to read as follows:

Controlled Substances Listed in Sechedules III, IV, and V


Sec. 1306.21  Requirement of prescription.

    (a) A pharmacist may dispense directly a controlled substance 
listed in Schedule III, IV, or V which is a prescription drug as 
determined under the Federal Food, Drug, and Cosmetic Act, only 
pursuant to either a written prescription signed by a practitioner or a 
facsimile of a written, signed prescription transmitted by the 
practitioner or the practitioner's agent to the pharmacy or pursuant to 
an oral prescription made by an individual practitioner and promptly 
reduced to writing by the pharmacist containing all information 
required in Sec. 1306.05, except for the signature of the practitioner.
    (b) An individual practitioner may administer or dispense directly 
a controlled substance listed in Schedule III, IV, or V in the course 
of his/her professional practice without a prescription, subject to 
Sec. 1306.07.
    (c) An institutional practitioner may administer or dispense 
directly (but not prescribe) a controlled substance listed in Schedule 
III, IV, or V only pursuant to a written prescription signed by an 
individual practitioner, or pursuant to a facsimile of a written 
prescription or order for medication transmitted by the practitioner or 
the practitioner's agent to the institutional practitioner-pharmacist, 
or pursuant to an oral prescription made by an individual practitioner 
and promptly reduced to writing by the pharmacist (containing all 
information required in Section 1306.05 except for the signature of the 
individual practitioner), or pursuant to an order for medication made 
by an individual practitioner which is dispensed for immediate 
administration to the ultimate user, subject to Sec. 1306.07.
    8. Section 1306.23 is amended by revising the introductory text to 
read as follows:


Sec. 1306.23  Partial filling of prescriptions.

    The partial filling of a prescription for a controlled substance 
listed in Schedule III, IV, or V is permissible, provided that:
* * * * *
    9. Section 1306.24 is revised to read as follows:


Sec. 1306.24  Labeling of substances and filing of prescriptions.

    (a) The pharmacist filling a prescription for a controlled 
substance listed in Schedule III, IV, or V shall affix to the package a 
label showing the pharmacy name and address, the serial number and date 
of initial filling, the name of the patient, the name of the 
practitioner issuing the prescription, and directions for use and 
cautionary statements, if any, contained in such prescription as 
required by law.
    (b) The requirements of paragraph (a) of this section do not apply 
when a controlled substance listed in Schedule III, IV, or V is 
prescribed for administration to an ultimate user who is 
institutionalized: Provided, That:
    (1) Not more than a 34-day supply or 100 dosage units, whichever is 
less, of the controlled substance listed in Schedule III, IV, or V is 
dispensed at one time;
    (2) The controlled substance listed in Schedule III, IV, or V is 
not in the possession of the ultimate user prior to administration;
    (3) The institution maintains appropriate safeguards and records 
the proper administration, control, dispensing, and storage of the 
controlled substance listed in Schedule III, IV, or V; and
    (4) The system employed by the pharmacist in filling a prescription 
is adequate to identify the supplier, the product and the patient, and 
to set forth the directions for use and cautionary statements, if any, 
contained in the prescription or required by law.
    (c) All prescriptions for controlled substances listed in Schedules 
III, IV, and V shall be kept in accordance with Sec. 1304.04(h) of this 
chapter.


Sec. 1306.25  [Removed]

    10. Section 1306.25 is removed.

[[Page 13966]]

Sec. 1306.26  [Redesignated as Sec. 1306.25 and amended]

    11. Section 1306.26 is redesignated as Sec. 1306.25 and amended by 
revising paragraphs (a) and (b) to read as follows:


Sec. 1306.25  Transfer between pharmacies of prescription information 
for Schedules III, IV, and V controlled substances for refill purposes.

    (a) The transfer of original prescription information for a 
controlled substance listed in Schedules III, IV or V for the purpose 
of refill dispensing is permissible between pharmacies on a one time 
basis only. However, pharmacies electronically sharing a real-time, on-
line database may transfer up to the maximum refills permitted by law 
and the prescriber's authorization. Transfers are subject to the 
following requirements:
    (1) The transfer is communicated directly between two licensed 
pharmacists and the transferring pharmacist records the following 
information:
    (i) Write the word ``VOID'' on the face of the invalidated 
prescription.
    (ii) Record on the reverse of the invalidated prescription the 
name, address and DEA registration number of the pharmacy to which it 
was transferred and the name of the pharmacist receiving the 
prescription information.
    (iii) Record the date of the transfer and the name of the 
pharmacist transferring the information.
    (b) The pharmacist receiving the transferred prescription 
information shall reduce to writing the following:
    (1) Write the word ``transfer'' on the face of the transferred 
prescription.
    (2) Provide all information required to be on a prescription 
pursuant to 21 CFR 1306.05 and include:
    (i) Date of issuance of original prescription;
    (ii) Original number of refills authorized on original 
prescription;
    (iii) Date of original dispensing;
    (iv) Number of valid refills remaining and date(s) and locations of 
previous refill(s);
    (v) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription information was 
transferred;
    (vi) Name of pharmacist who transferred the prescription.
    (vii) Pharmacy's name, address, DEA registration number and 
prescription number from which the prescription was originally filled;
    (3) The original and transferred prescription(s) must be maintained 
for a period of two years from the date of last refill.
* * * * *


Sec. Undesignated center heading and Sec. 1306.31  [Removed]

    12. The undesignated heading preceding Sec. 1306.31 and 
Sec. 1306.31 are removed.


Sec. 1306.32  [Redesignated as Sec. 1306.26 and amended]

    13. Sec. 1306.32 is redesignated as Sec. 1306.26 and the 
introductory text and paragraph (a) revised to read as follows:


Sec. 1306.26  Dispensing without prescription.

    A controlled substance listed in Schedules II, III, IV, or V which 
is not a prescription drug as determined under the Federal Food, Drug, 
and Cosmetic Act, may be dispensed by a pharmacist without a 
prescription to a purchaser at retail, provided that:
    (a) Such dispensing is made only by a pharmacist (as defined in 
part 1300 of this chapter), and not by a nonpharmacist employee even if 
under the supervision of a pharmacist (although after the pharmacist 
has fulfilled his professional and legal responsibilities set forth in 
this section, the actual cash, credit transaction, or delivery, may be 
completed by a nonpharmacist);
* * * * *
    14. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
                 Section                                  Remove                               Add              
----------------------------------------------------------------------------------------------------------------
1306.03(a)(2)...........................  1301.24(c)...........................  1301.22(c)                     
1306.03(a)(2)...........................  1301.25..............................  1301.23                        
1306.05(b)..............................  1301.24(c)...........................  1301.22(c)                     
1306.05(c)..............................  1301.25..............................  1301.22(c)                     
1306.22(a)(2)...........................  practioner...........................  practitioner                   
1306.22(b), introductory text...........  retrival.............................  retrieval                      
1306.22(b)(2)...........................  duing................................  during                         
1306.22(b)(4)...........................  Compliance...........................  Diversion                      
----------------------------------------------------------------------------------------------------------------

PART 1307--[AMENDED]

    1. The authority citation for part 1307 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822(d), 871(b).

    2. Section 1307.01 is revised to read as follows:


Sec. 1307.01  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.
    3. Section 1307.02 is revised to read as follows:


Sec. 1307.02  Application of State law and other Federal law.

    Nothing in this chapter shall be construed as authorizing or 
permitting any person to do any act which such person is not authorized 
or permitted to do under other Federal laws or obligations under 
international treaties, conventions or protocols, or under the law of 
the State in which he/she desires to do such act nor shall compliance 
with such parts be construed as compliance with other Federal or State 
laws unless expressly provided in such other laws.
    4. Section 1307.03 is revised to read as follows:


Sec. 1307.03  Exceptions to regulations.

    Any person may apply for an exception to the application of any 
provision of this chapter by filing a written request stating the 
reasons for such exception. Requests shall be filed with the 
Administrator, Drug Enforcement Administration, Department of Justice, 
Washington, DC 20537. The Administrator may grant an exception in his 
discretion, but in no case shall he/she be required to grant an 
exception to any person which is otherwise required by law or the 
regulations cited in this section.


Sec. 1307.12  [Removed]

    5. Section 1307.12 is removed.

[[Page 13967]]

Sec. 1307.13  [Redesignated as Sec. 1307.12]

    6. Section 1307.13 is redesignated as Sec. 1307.12.


Sec. 1307.14  [Removed]

    7. Section 1307.14 is removed.


Sec. 1307.15  [Redesignated as Sec. 1307.13]

    8. Section 1307.15 is redesignated as Sec. 1307.13.
    9. Section 1307.21 is amended by revising paragraph (a) to read as 
follows:


Sec. 1307.21  Procedure for disposing of controlled substances.

    (a) Any person in possession of any controlled substance and 
desiring or required to dispose of such substance may request 
assistance from the Special Agent in Charge of the Administration in 
the area in which the person is located for authority and instructions 
to dispose of such substance. The request should be made as follows:
    (1) If the person is a registrant, he/she shall list the controlled 
substance or substances which he/she desires to dispose of on DEA Form 
41, and submit three copies of that form to the Special Agent in Charge 
in his/her area; or
    (2) If the person is not a registrant, he/she shall submit to the 
Special Agent in Charge a letter stating:
    (i) The name and address of the person;
    (ii) The name and quantity of each controlled substance to be 
disposed of;
    (iii) How the applicant obtained the substance, if known; and
    (iv) The name, address, and registration number, if known, of the 
person who possessed the controlled substances prior to the applicant, 
if known.
* * * * *
    10. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
                 Section                                  Remove                               Add              
----------------------------------------------------------------------------------------------------------------
1307.11(a)(2)...........................  1304.24(e)...........................  1304.22(c)                     
1307.11(a)(2)...........................  1304.24(c)...........................  1304.22(c)                     
1307.11(a)(4)...........................  1301.28..............................  1301.25                        
1307.11(b)..............................  1301.28..............................  1301.25                        
1307.22.................................  28083................................  20537                          
----------------------------------------------------------------------------------------------------------------

PART 1308--[AMENDED]

    1. The authority citation for part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b).

    2. Section 1308.02 is revised to read as follows:


Sec. 1308.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.


Sec. 1308.04  [Removed]

    3. Section 1308.04 is removed.
    4. Section 1308.24 is amended by removing the Exempt Chemical 
Preparations Table and revising paragraphs (a) and (i) to read as 
follows:


Sec. 1308.24  Exempt chemical preparations.

    (a) The chemical preparations and mixtures approved pursuant to 
Sec. 1308.23 are exempt from application of sections 302, 303, 305, 
306, 307, 308, 309, 1002, 1003 and 1004 of the Act (21 U.S.C. 822-823, 
825-829, 952-954) and Sec. 1301.74 of this chapter, to the extent 
described in paragraphs (b) to (h) of this section. Substances set 
forth in paragraph (j) of this section shall be exempt from the 
application of sections 305, 306, 307, 308, 309, 1002, 1003 and 1004 of 
the Act (21 U.S.C. 825-829, 952-954) and Secs. 1301.71--1301.73 and 
1301.74 (a), (b), (d), (e) and (f) of this chapter to the extent as 
hereinafter may be provided.
* * * * *
    (i) A listing of exempt chemical preparations may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Washington, DC 20537.
* * * * *
    5. In Sec. 1308.26(a) the Table of Excluded Veterinary Anabolic 
Steroid Implant Products is removed. As revised, Sec. 1308.26(a) reads 
as follows:


Sec. 1308.26  Excluded veterinary anabolic steroid implant products.

    (a) Products containing an anabolic steroid, that are expressly 
intended for administration through implants to cattle or other 
nonhuman species and which have been approved by the Secretary of 
Health and Human Services for such administration are excluded from all 
schedules pursuant to section 102(41)(B)(I) of the Act (21 U.S.C. 
802(41)(B)(I)). A listing of the excluded products may be obtained by 
submitting a written request to the Drug and Chemical Evaluation 
Section, Drug Enforcement Administration, Washington DC 20537.
* * * * *
    6. In Sec. 1308.32 the Table of Exempted Prescription Products is 
removed. As revised, Section 1308.32 reads as follows:


Sec. 1308.32  Exempted prescription products.

    The compounds, mixtures, or preparations that contain a nonnarcotic 
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13 (b) 
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of 
Exempted Prescription Products have been exempted by the Administrator 
from the application of sections 302 through 305, 307 through 309, 1002 
through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954) and 
Secs. 1301.13, 1301.22, and Secs. 1301.71 through 1301.76 of this 
chapter for administrative purposes only. An exception to the above is 
that those products containing butalbital shall not be exempt from the 
requirement of 21 U.S.C. 952-954 concerning importation, exportation, 
transshipment and in-transit shipment of controlled substances. Any 
deviation from the quantitative composition of any of the listed drugs 
shall require a petition of exemption in order for the product to be 
exempted. A listing of the Exempted Prescription Products may be 
obtained by submitting a written request to the Drug and Chemical 
Evaluation Section, Drug Enforcement Administration, Washington, DC 
20537.
    7. In Sec. 1308.34 the Table of Exempt Anabolic Steroid Products is 
removed. As revised, Sec. 1308.34 reads as follows:


Sec. 1308.34  Exempt anabolic steroid products.

    The list of compounds, mixtures, or preparations that contain an 
anabolic steroid that have been exempted by the Administrator from 
application of sections 302 through 309 and 1002 through 1004 of the 
Act (21 U.S.C. 822-829 and 952-954) and Secs. 1301.13, 1301.22, and 
1301.71 through 1301.76 of this chapter for administrative purposes 
only may be obtained by submitting a written request to the Drug and 
Chemical Evaluation Section, Drug Enforcement Administration, 
Washington, DC 20537.

[[Page 13968]]

    8. Sec. 1308.42 is revised to read as follows:


Sec. 1308.42  Purpose of hearing.

    If requested by any interested person after proceedings are 
initiated pursuant to Sec. 1308.43, the Administrator shall hold a 
hearing for the purpose of receiving factual evidence and expert 
opinion regarding the issues involved in the issuance, amendment or 
repeal of a rule issuable pursuant to section 201(a) of the Act (21 
U.S.C. 811(a)). Extensive argument should not be offered into evidence 
but rather presented in opening or closing statements of counsel or in 
memoranda or proposed findings of fact and conclusions of law. 
Additional information relating to hearings to include waivers or 
modification of rules, request for hearing, burden of proof, time and 
place, and final order are set forth in Part 1316 of this chapter.


Section 1308.43  [Removed]

    9. Section 1308.43 is removed.


Sec. 1308.44  [Redesignated as Sec. 1308.43 and amended]

    10. Section 1308.44 is redesignated as Sec. 1308.43 and the 
citation ``1308.45'' in paragraph (f) is revised to read ``1308.44'':


Sec. 1308.45  [Redesignated as Sec. 1308.44 and amended]

    11. Section 1308.45 is redesignated as Sec. 1308.44 and the 
citation in paragraph (e) ``1308.48'' is revised to read ``1308.45''.


Secs. 1308.46 and 1308.47  [Removed]

    12. Sections 1308.46 and 1308.47 are removed.


Secs. 1308.48-1308.50  [Redesignated as Secs. 1308.45-1308.47]

    13. Sections 1308.48 through 1308.50 are redesignated as 
Secs. Sections 1308.45 through 1308.47.


Section 1308.51  [Removed]

    14. Section 1308.51 is removed.


Sec. 1308.52  [Redesignated as Sec. 1308.49 and corrected]

    15. Section 1308.52 is redesignated as Sec. 1308.49 and the 
typographical error ``withott'' in the introductory text is corrected 
to read ``without''.
    16. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
             Section                           Remove                                   Add                     
----------------------------------------------------------------------------------------------------------------
Table of Contents for Part 1308..  1308.52 sheduling.............  1308.52 scheduling                           
1308.03(a).......................  1301.44 and 1311.43...........  1301.35                                      
1308.12(g).......................  prectrsors....................  precursors                                   
1308.13(b)(1)....................  quantitive....................  quantitative                                 
1308.13(b)(1)....................  lirted........................  listed                                       
1308.13(b)(1)....................  308.32........................  1308.32                                      
1308.22, title of table..........  nonarcotic....................  nonnarcotic                                  
1308.23(c)(7)....................  1302.01.......................  Part 1300 of this chapter                    
1308.23(f).......................  revoje........................  revoke                                       
1308.24(d).......................  Drug Control..................  Drug and Chemical Evaluation                 
1308.33(a).......................  1308.02.......................  Part 1300 of this chapter                    
1308.33(b).......................  1308.02.......................  Part 1300 of this chapter                    
----------------------------------------------------------------------------------------------------------------

PART 1309--[AMENDED]

    1. The authority citation for part 1309 continues to read as 
follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877, 
958.

    2. Section 1309.02 is revised to read as follows:


Sec. 1309.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.


Secs. 1309.53 and 1309.57  [Removed] and


Secs. 1309.54-1309.56  [Redesignated as Secs. 1309.53-1309.55]

    3. Sections 1309.53 and 1309.57 are removed and Secs. 1309.54 
through 1309.56 are redesignated as Secs. 1309.53 through 1309.55.
    4. In addition to the amendments set forth above, DEA is removing 
the words ``Sec. 1310.01(f)(1)(iv) and adding in their place the words 
``Sec. 1300.01(b)(28)(i)(D)'' in the following places:
    (a) Section 1309.02(g)
    (b) Section 1309.21 (a) and (b)
    (c) Section 1309.25 (a) and (b); and
    (d) Section 1309.71(a)(2).

PART 1310--[AMENDED]

    1. The authority citation for part 1310 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b).

    2. Section 1310.01 is revised to read as follows:


Sec. 1310.01  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


Sec. 1310.05  [Amended]

    3. Section 1310.05(c) is amended by removing the words ``as defined 
in Sec. 1310.01(i)'' and ``as defined in Sec. 1310.01(j)''


Sec. 1310.08  [Amended]

    4. Section 1310.08 introductory text is amended by removing the 
words ``contained in 21 CFR 1310.01(f) and 1313.02(d)''


Sec. 1310.09  [Removed]

    5. Section 1310.09 is removed.
    6. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
             Section                           Remove                                   Add                     
----------------------------------------------------------------------------------------------------------------
1310.10(a).......................  1310.01(f)(1)(iv).............  1300.01(b)(28)(i)(D)                         
1310.14(a).......................  1310.01(f)(1)(iv)(A)..........  1300.01(b)(28)(i)(D)(1)                      
1310.15(d).......................  1310.01(f)(1)(iv)(A)..........  1300.01(b)(28)(i)(D)(1)                      
----------------------------------------------------------------------------------------------------------------


[[Page 13969]]

PART 1311--[REMOVED AND RESERVED]

    Part 1311 is removed and reserved.

PART 1312--[AMENDED]

    1. The authority citation for part 1312 continues to read as 
follows:

    Authority: 21 U.S.C. 952, 953, 954, 957, 958.

    2. Section 1312.02 is revised to read as follows:


Sec. 1312.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or Part 1300 of this chapter.
    3. Part 1312 is amended to remove the words, ``1405 I Street, NW'' 
and ``1405 Eye Street, NW.'', in the following sections:
    (a) 1312.12(a);
    (b) 1312.16(b);
    (c) 1312.18(b);
    (d) 1312.19(b);
    (e) 1312.22(a);
    (f) 1312.24(a);
    (g) 1312.27(a);
    (h) 1312.27(b)(5)(iv);
    (i) 1312.28(d);
    (j) 1312.31(b); and
    (k) 1312.32(a).
    4. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

----------------------------------------------------------------------------------------------------------------
             Section                           Remove                                   Add                     
----------------------------------------------------------------------------------------------------------------
1312.12(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.14(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.16(b).......................  Drug Control Section..........  Drug Operations Section                      
1312.17..........................  304...........................  1304                                         
1312.18(b).......................  Drug Control Section..........  Drug Operations Section                      
1312.18(c).......................  (or BND)......................                                               
1312.19(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.19(b).......................  Drug Control Section..........  Drug Operations Section                      
1312.22(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.24(a).......................  Bureau........................  Administration                               
1312.24(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.25..........................  Drug Control Section..........  Drug Operations Section                      
1312.27(a).......................  regirtered....................  registered                                   
1312.27(a).......................  Drug Control Section..........  Drug Operations Section                      
1312.27(b)(5)(iii)...............  inital........................  initial                                      
1312.27(b)(5)(iv)................  Drug Control Section..........  Drug Operations Section                      
1312.28(d).......................  Drug Control Section..........  Drug Operations Section                      
1312.28(d).......................  1327.27(b)(4).................  1312.27(b)(4)                                
1312.31(b).......................  Drug Control Section..........  Drug Operations Section                      
1312.32(a).......................  Drug Control Section..........  Drug Operations Section                      
----------------------------------------------------------------------------------------------------------------

PART 1313--[AMENDED]

    1. The authority citation for part 1313 continues to read as 
follows:

    Authority: 21 U.S.C. 802, 830, 871(b), 971.

    2. Section 1313.02 is revised to read as follows:


Sec. 1313.02  Definitions.

    Any term used in this part shall have the definition set forth in 
section 102 of the Act (21 U.S.C. 802) or part 1300 of this chapter.


Sec. 1313.15  [Amended]

    3. Section 1313.15(a) is amended by removing the words 
``Sec. 1313.02(i)'' and replacing them with the words 
``Sec. 1300.02(b)(13)''


Sec. 1313.21  [Amended]

    4. Section 1313.21(c)(1) is amended by removing the words 
``Sec. 1313.02(j)'' and replacing them with the words 
``Sec. 1300.02(b)(12)''


Sec. 1313.24  [Amended]

    5. Section 1313.24(a) is amended by removing the words 
``Sec. 1313.02(j)'' and replacing them with the words 
``Sec. 1300.02(b)(12)''

PART 1316--[AMENDED]

    1. The authority citation for part 1316 continues to read as 
follows:

    Authority: 21 U.S.C. 822(f), 830(a), 871(b), 880, 958(f), 965.

    2. Section 1316.02 is amended by revising paragraph (g) to read as 
follows:


Sec. 1316.02  Definitions.

* * * * *
    (g) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.
    3. Section 1316.13 is amended by revising the text to read as 
follows:


Sec. 1316.13  Frequency of administrative inspections.

    Except where circumstances otherwise dictate, it is the intent of 
the Administration to inspect all manufacturers of controlled 
substances listed in Schedules I and II and distributors of controlled 
substances listed in Schedule I once each year. Distributors of 
controlled substances listed in Schedules II through V and 
manufacturers of controlled substances listed in Schedules III through 
V shall be inspected as circumstances may require, based in part on the 
registrant's history of compliance with the requirements of this 
chapter and maintenance of effective controls and procedures to guard 
against the diversion of controlled substances.
    4. Section 1316.42 is amended by revising paragraph (h) to read as 
follows:


Sec. 1316.42  Definitions.

* * * * *
    (h) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.
    5. Section 1316.71 is amended by revising paragraph (f) to read as 
follows:


Sec. 1316.71  Definitions.

* * * * *
    (f) Any term not defined in this part shall have the definition set 
forth in section 102 of the Act (21 U.S.C. 802) or part 1300 of this 
chapter.
    6. In addition to the amendments set forth above, DEA is amending 
each section indicated in the left column by removing the words 
indicated in the middle column and adding the words in the right 
column:

[[Page 13970]]



----------------------------------------------------------------------------------------------------------------
               Section                               Remove                                 Add                 
----------------------------------------------------------------------------------------------------------------
1316.05..............................  1314.06..........................  1316.06                               
1316.05..............................  1316.09-1316.14..................  1316.09-1316.13                       
1316.12..............................  21 U.S.C. (a)(6).................  21 U.S.C. 842(a)(6)                   
1316.23(b)...........................  1405 I Street....................                                        
1316.24(c)...........................  1316.21(b).......................  1316.23(b)                            
1316.24(c)...........................  1316.22(b).......................  1316.24(b)                            
1316.41..............................  1303.41-1303.47..................  1303.31-1303.37                       
                                                                          1313.51-1313.57                       
1316.46(b)(1)........................  1301.32(a)(3)....................  1301.32(a)(6)                         
1316.52(a)...........................  1301.60..........................  1301.56                               
1316.77(a)...........................  fovard...........................  forward                               
1316.81..............................  proceeeding......................  proceeding                            
----------------------------------------------------------------------------------------------------------------


    Dated: February 26, 1997.
James Milford,
Acting Deputy Administrator, Drug Enforcement Administration.
[FR Doc. 97-7036 Filed 3-21-97; 8:45 am]
BILLING CODE 4410-09-P