13938 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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 §§ 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 § 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 § 1300.01 and the words ‘‘home

infusion pharmacy’’ in § 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 §§ 1300.01 and 1300.02

be removed from one of the sections;

and that the references to ‘‘this section’’

in § 1300.02(b)(12) and to ‘‘this part’’ in

§ 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, § 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

§ 1300.02(b)(12) will be replaced with

the phrase ‘‘for purposes of this

definition’’ and the reference to ‘‘this

part’’ in § 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 § 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 § 1301.13. One

commentor stated that references to the
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13939

‘‘Secretary’’ in § 1301.32 are unclear; the

reference to ‘‘these substances’’ in

§ 1301.34(b)(3) should be clarified; the

reference to ‘‘hearing’’ in § 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; § 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

§ 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

§ 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 § 1301.35(b);

and the phrase ‘‘to import or’’ will be

added to §§ 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 § 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 § 1304.04(e). This

sentence was in fact removed in the

proposed rule.

Two commentors supported the

change to § 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 § 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

§§ 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 § 1304.33

which puts ARCOS reporting on a

quarterly rather than a monthly

schedule. One commentor

recommended that § 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 offsite 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 § 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 § 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

§ 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 § 1305.11(a)(1) be

modified to explain when an Order

Form is not ‘‘complete.’’ DEA believes

that the term ‘‘complete’’ is selfexplanatory, 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 § 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
13940 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

to ease the recordkeeping burden for

physicians and pharmacies for noninstitutionalized 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 § 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

§§ 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 § 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

§ 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

§ 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 § 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
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13941

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)

§ 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

§ 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 § 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

§ 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

§ 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

§ 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
13942 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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

§ 1308.11(d) and § 1308.12(b)(4) of this

chapter. As used in § 1308.11(d) of this

chapter, the term isomer means the

optical, positional, or geometric isomer.

As used in § 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 midlevel practitioners include, but are not

limited to, health care providers such as

nurse practitioners, nurse midwives,
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 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 § 1305.08 of this

chapter.

§ 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
13944 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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 § 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 § 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 § 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 § 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

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

§ 1300.02(b)(28)(i)(D), directly to walkin 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 semisolid 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:

§ 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:

§ 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

§§ 1301.11 through 1301.52 and the

undesignated center headings and by

removing §§ 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

§ 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

§§ 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.)

§ 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
13946 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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.

§ 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)

Business activity Controlled substances

DEA application

forms

Application

fee

(dollars)

Registration

period

(years)

Coincident activities allowed

(i) Manufacturing .............................. Schedules I

through V.

New—225 ...........

Renewal—225a ..

875

875

1 Schedules I through 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

through V.

New—225 ...........

Renewal—225a ..

438

438

1
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13947

Business activity Controlled substances

DEA application

forms

Application

fee

(dollars)

Registration

period

(years)

Coincident activities allowed

(iii) Dispensing or Instructing (Includes Practitioner Hospital/Clinic,

Retail Pharmacy, Teaching Institution).

Schedules II

through V.

New—224 ...........

Renewal—224a ..

210

210

3 May conduct research and instructional activities with those substances 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 ...........

Renewal—225a ..

70

70

1 A researcher may 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

through V.

New—225 ...........

Renewal—225a ..

70

70

1 May conduct chemical 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 Program (including compounder).Narcotic Drugs in

Schedules II

through V.

New—363 ...........

Renewal—363a ..

70

70

1

(vii) Importing ................................... Schedules I

through V.

New—225 ...........

Renewal—225a ..

438

438

1 May distribute that substance or

class for which registration was

issued; may not distribute any

substance or class for which not

registered.

(viii) Exporting .................................. Schedules I

through V.

New—225 ...........

Renewal—225a ..

438

438

1
13948 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

Business activity Controlled substances

DEA application

forms

Application

fee

(dollars)

Registration

period

(years)

Coincident activities allowed

(ix) Chemical Analysis ..................... Schedules I

through V.

New—225 ...........

Renewal—225a ..

70

70

1 May manufacture and 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.

§ 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 § 1301.15 and has no

bearing on whether the application will

be granted.

§ 1301.15 Additional information.

The Administrator may require an

applicant to submit such documents or
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 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.

§ 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

§ 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.

§ 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, llllllllll, the

llllllllll (Title of officer,

official, partner, or other position) of

llllllllll (Corporation,

partnership, or sole proprietor), doing

business as llllllllll (Store

name) at llllllllll (Number and

Street), llllllllll (City)

llllll (State) llllll (Zip code),

hereby certify that said store was issued a

pharmacy permit No. llll by the

llllllll (Board of Pharmacy or

Licensing Agency) of the State of

llllll on llllll (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.

lllllllllllllllllllll

Signature (Person who signs Application for

Registration)

State of lllllllllllllllll

County of llllllllllllllll

Subscribed to and sworn before me this

llll day of llll, 19lll.

lllllllllllllllllllll

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, llllllllll, the

llllllllll (Title of officer,

official, partner or other position) of

llllllllll (Corporation,

partnership, or sole proprietor), doing

business as llllllllll (Store

name) hereby certify:

(1) That said company was issued a

pharmacy permit No.llllllby the

llllllllll (Board of Pharmacy of

Licensing Agency) of the State of

llllll and a DEA Registration Number

llllllllll for a pharmacy located

at llllllllll (Number and Street)

llllll (City) llllll (State)

llllll (Zip Code); and

(2) That said company is acquiring the

pharmacy business of llllllllll

(Name of Seller) doing business

asllllllllllwith DEA

Registration Number llllll on or

about llllll (Date of Transfer) and

that said company has applied (or will apply

on llllll (Date) for a pharmacy permit

from the board of pharmacy (or licensing

agency) of the State of llllll to do

business as llllllllll (Store

name) at llllllllll (Number and

Street) llllllllll (City)

llllll (State) llllll (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.

lllllllllllllllllllll

Signature (Person who signs Application for

Registration)

State of lllllllllllllllll

County of llllllllllllllll

Subscribed to and sworn before me

thisllday ofllllll, 19ll.

lllllllllllllllllllll

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.

§ 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.
13950 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

(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

§ 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 § 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

llllllllll (Date), pursuant to 21

U.S.C. 355(i) and 21 CFR 130.3, I,

llllllllll (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:

lllllllllllllllllllll

(Name of Investigational Drug).

lllllllllllllllllllll

(Date)

lllllllllllllllllllll

(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

§ 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.

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

§ 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.

§ 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

§ 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

§ 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.

§ 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
13952 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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) lllllllllll

(Address of registrant) llllllllll

(DEA registration number) llllllll

Line No. Number of packages ordered Size of packages Name of product Packages

distributed Date distributed

1 .............................................................. .............................. .............................. .............................. .............................. ..............................

2 .............................................................. .............................. .............................. .............................. .............................. ..............................

3 .............................................................. .............................. .............................. .............................. .............................. ..............................

Footnote: Line numbers may be continued according to needs of the vendor.

Number of lines completed llllllll

Name of vessel lllllllllllll

Vessel’s official number lllllllll

Vessel’s country of registry llllllll

Owner or operator of the vessel llllll

Name and title of vessel’s officer who

presented the requisition llll

Signature of vessel’s officer who presented

the requisition llll

(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 § 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 § 1307.21 of

this chapter.

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

§ 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.

§ 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 § 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.

§ 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 § 1301.13(e)(1).

§ 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

§ 1301.43. If a hearing is requested, the

Administrator shall hold a hearing on

the application in accordance with

§ 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 § 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 § 1301.35 or

§ 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
13954 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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 §§ 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.

§ 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 § 1301.37 and, if requested by the

applicant, shall hold a hearing on the

application pursuant to § 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 § 1301.33(a)

may participate in the hearing by filing

notice of appearance in accordance with

§ 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.
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13955

§ 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 § 1301.37 and, if requested by the

registrant, shall hold a hearing pursuant

to § 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 § 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 § 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.

§ 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,
13956 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

if he/she desires a hearing, file a request

for a hearing pursuant to § 1301.43. If a

hearing is requested, the Administrator

shall hold a hearing at the time and

place stated in the order, pursuant to

§ 1301.41.

(e) When authorized by the

Administrator, any agent of the

Administration may serve the order to

show cause.

Hearings

§ 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 §§ 1301.42–

1301.46 of this part, and by the

procedures for administrative hearings

under the Act set forth in §§ 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.

§ 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.

§ 1301.43 Request for hearing or

appearance; waiver.

(a) Any person entitled to a hearing

pursuant to § 1301.32 or §§ 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

§ 1301.34), file with the Administrator a

written request for a hearing in the form

prescribed in § 1316.47 of this chapter.

(b) Any person entitled to participate

in a hearing pursuant to § 1301.34 or

§ 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 § 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

§ 1301.32 or §§ 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 § 1301.32 or §§ 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 § 1301.46

without a hearing.

§ 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 § 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

§ 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.

§ 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

§ 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.

§ 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

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

§ 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 § 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 registranttransferor 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 § 1304.11 of this

chapter. This inventory shall serve as

the final inventory of the registranttransferor 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 registranttransferor 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 registranttransferee 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:

§ 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:

§ 1301.76 Other security controls for

practitioners.

* * * * *

(c) Whenever the registrant distributes

a controlled substance (without being

registered as a distributor, as permitted

in § 1301.13(e)(1) and/or §§ 1307.11–

1307.12) he/she shall comply with the

requirements imposed on

nonpractitioners in § 1301.74(a), (b), and

(e).

§ 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’.
13958 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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:

§ 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:

§ 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.

§ 1302.05 [Removed]

4. Section 1302.05 is removed.

5. Section 1302.06 is redesignated as

§ 1302.05 and revised to read as follows:

§ 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 § 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

§ 1302.06 and revised to read as follows:

§ 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

§ 1302.07 and revised to read as follows:

§ 1302.07 Labeling and packaging

requirements for imported and exported

substances.

(a) The symbol requirements of

§§ 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

§§ 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

§ 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:

§ 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:

§ 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:

§ 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),
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13959

introductory text, and by adding

‘‘executed’’ in its place and by revising

paragraphs (e) and (h) to read as follows:

§ 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:

§ 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 §§ 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 § 1301.13 or §§ 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 § 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
13960 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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.

§§ 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:

§ 1304.21 General requirements for

continuing records.

(a) Every registrant required to keep

records pursuant to § 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

§ 1304.22(d).

* * * * *

8. Section 1304.22 is revised to read

as follows:

§ 1304.22 Records for manufacturers,

distributors, dispensers, researchers,

importers and exporters.

Each person registered or authorized

(by § 1301.13(e) or §§ 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
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13961

required by § 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.

§ 1304.23–1304.26 [Removed]

9. Sections 1304.23 through 1304.26

are removed.

§ 1304.27 [Redesignated as § 1304.23]

10. Section 1304.27 is redesignated as

§ 1304.23.

§ 1304.28 [Redesignated as § 1304.24 and

amended]

11. Section 1304.28 is redesignated as

§ 1304.24 and reference in § 1304.28(b)

to ‘‘§ 1304.24’’ is revised to read

‘‘§ 1304.22’’, and in paragraph (d), the

words ‘‘part 1401 of this title’’ are

revised to read ‘‘42 CFR Part 2.’’

§ 1304.29 [Redesignated as § 1304.25]

12. Section 1304.29 is redesignated as

§ 1304.25.

13. Section 1304.31 is revised to read

as follows:

§ 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;
13962 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

(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:

§ 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.

§ 1304.33 [Removed]

15. Section 1304.33 is removed.

§ 1304.34 [Redesignated as § 1304.33 and

reviewes]

16. Section 1304.34 is redesignated as

§ 1304.33 and revised to read as follows:

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

§§ 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:

§ 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:

§ 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:

§ 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:

§ 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

lllll (Name of registrant)

lllll (Address of registrant)

lllll (DEA registration number)

I, lllll (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 lllll (name of attorney-infact), 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)
13964 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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.

lllllllllllllllllllll

(Signature of person granting power)

I, lllll (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.

lllllllllllllllllllll

(Signature of attorney-in-fact)

Witnesses:

1. lllll.

2. lllll.

Signed and dated on the lll day of

lllll, (year), at lllll.

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 lllll

this same day.

lllllllllllllllllllll

(Signature of person revoking power)

Witnesses:

1. lllll.

2. lllll.

Signed and dated on the lll day of

lllll, (year), at lllll.

6. Section 1305.12 is amended by

revising paragraph (b) to read as follows:

§ 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:

§ 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:

§ 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 § 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 § 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 § 1306.05 written for a
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 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 § 1304.04(h) of this

chapter.

* * * * *

(g) A prescription prepared in

accordance with § 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 § 1304.04(h) of this

chapter.

4. Section 1306.13 is amended by

revising paragraph (b) to read as follows:

§ 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:

§ 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

§ 1304.04(h) of this chapter.

§ 1306.15 [Removed]

6. Section 1306.15 is removed.

7. The center undesignated heading

preceding § 1306.21 and § 1306.21 are

revised to read as follows:

Controlled Substances Listed in

Sechedules III, IV, and V

§ 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 § 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 § 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 practitionerpharmacist, 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

§ 1306.07.

8. Section 1306.23 is amended by

revising the introductory text to read as

follows:

§ 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:

§ 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

§ 1304.04(h) of this chapter.

§ 1306.25 [Removed]

10. Section 1306.25 is removed.
13966 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

§ 1306.26 [Redesignated as § 1306.25 and

amended]

11. Section 1306.26 is redesignated as

§ 1306.25 and amended by revising

paragraphs (a) and (b) to read as follows:

§ 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 realtime, 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.

* * * * *

§ Undesignated center heading and

§ 1306.31 [Removed]

12. The undesignated heading

preceding § 1306.31 and § 1306.31 are

removed.

§ 1306.32 [Redesignated as § 1306.26 and

amended]

13. § 1306.32 is redesignated as

§ 1306.26 and the introductory text and

paragraph (a) revised to read as follows:

§ 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:

§ 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:

§ 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:

§ 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.

§ 1307.12 [Removed]

5. Section 1307.12 is removed.
Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations 13967

§ 1307.13 [Redesignated as § 1307.12]

6. Section 1307.13 is redesignated as

§ 1307.12.

§ 1307.14 [Removed]

7. Section 1307.14 is removed.

§ 1307.15 [Redesignated as § 1307.13]

8. Section 1307.15 is redesignated as

§ 1307.13.

9. Section 1307.21 is amended by

revising paragraph (a) to read as follows:

§ 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:

§ 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.

§ 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:

§ 1308.24 Exempt chemical preparations.

(a) The chemical preparations and

mixtures approved pursuant to

§ 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

§ 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 §§ 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 § 1308.26(a) the Table of

Excluded Veterinary Anabolic Steroid

Implant Products is removed. As

revised, § 1308.26(a) reads as follows:

§ 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 § 1308.32 the Table of Exempted

Prescription Products is removed. As

revised, Section 1308.32 reads as

follows:

§ 1308.32 Exempted prescription products.

The compounds, mixtures, or

preparations that contain a nonnarcotic

controlled substance listed in

§ 1308.12(e) or in § 1308.13 (b) or (c) or

in § 1308.14 or in § 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 §§ 1301.13, 1301.22, and §§ 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 intransit 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 § 1308.34 the Table of Exempt

Anabolic Steroid Products is removed.

As revised, § 1308.34 reads as follows:

§ 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 §§ 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.
13968 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

8. § 1308.42 is revised to read as

follows:

§ 1308.42 Purpose of hearing.

If requested by any interested person

after proceedings are initiated pursuant

to § 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.

§ 1308.44 [Redesignated as § 1308.43 and

amended]

10. Section 1308.44 is redesignated as

§ 1308.43 and the citation ‘‘1308.45’’ in

paragraph (f) is revised to read

‘‘1308.44’’:

§ 1308.45 [Redesignated as § 1308.44 and

amended]

11. Section 1308.45 is redesignated as

§ 1308.44 and the citation in paragraph

(e) ‘‘1308.48’’ is revised to read

‘‘1308.45’’.

§§ 1308.46 and 1308.47 [Removed]

12. Sections 1308.46 and 1308.47 are

removed.

§§ 1308.48–1308.50 [Redesignated as

§§ 1308.45–1308.47]

13. Sections 1308.48 through 1308.50

are redesignated as §§ Sections 1308.45

through 1308.47.

Section 1308.51 [Removed]

14. Section 1308.51 is removed.

§ 1308.52 [Redesignated as § 1308.49 and

corrected]

15. Section 1308.52 is redesignated as

§ 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:

§ 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.

§§ 1309.53 and 1309.57 [Removed] and

§§ 1309.54–1309.56 [Redesignated as

§§ 1309.53–1309.55]

3. Sections 1309.53 and 1309.57 are

removed and §§ 1309.54 through

1309.56 are redesignated as §§ 1309.53

through 1309.55.

4. In addition to the amendments set

forth above, DEA is removing the words

‘‘§ 1310.01(f)(1)(iv) and adding in their

place the words ‘‘§ 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:

§ 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.

§ 1310.05 [Amended]

3. Section 1310.05(c) is amended by

removing the words ‘‘as defined in

§ 1310.01(i)’’ and ‘‘as defined in

§ 1310.01(j)’’

§ 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)’’

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

§ 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:

§ 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.

§ 1313.15 [Amended]

3. Section 1313.15(a) is amended by

removing the words ‘‘§ 1313.02(i)’’ and

replacing them with the words

‘‘§ 1300.02(b)(13)’’

§ 1313.21 [Amended]

4. Section 1313.21(c)(1) is amended

by removing the words ‘‘§ 1313.02(j)’’

and replacing them with the words

‘‘§ 1300.02(b)(12)’’

§ 1313.24 [Amended]

5. Section 1313.24(a) is amended by

removing the words ‘‘§ 1313.02(j)’’ and

replacing them with the words

‘‘§ 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:

§ 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:

§ 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:

§ 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:

§ 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:
13970 Federal Register / Vol. 62, No. 56 / Monday, March 24, 1997 / Rules and Regulations

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