[Federal Register Volume 79, Number 227 (Tuesday, November 25, 2014)]
[Rules and Regulations]
[Pages 70085-70090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27917]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-394]
RIN 1117-AB38


Exemption From Registration for Persons Authorized Under U.S. 
Nuclear Regulatory Commission or Agreement State Medical Use Licenses 
or Permits and Administering the Drug Product DaTscan<SUP>TM</SUP>

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Interim final rule with request for comment.

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

SUMMARY: The Drug Enforcement Administration (DEA) is amending its 
regulations to waive the requirement of registration for persons who 
are authorized under United States Nuclear Regulatory Commission or 
Agreement State medical use licenses or permits and administer the drug 
product DaTscan\TM\.

DATES: Effective November 25, 2014. Interested persons may file written 
comments on this interim final rule pursuant to 5 U.S.C. 553. 
Electronic comments must be submitted, and written comments must be 
postmarked, on or before January 26, 2015. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-394'' on all electronic and written correspondence. 
The DEA encourages that all comments be submitted electronically 
through the Federal eRulemaking Portal which provides the ability to 
type short comments directly into the comment field on the Web page or 
attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for 
submitting comments. Paper comments that duplicate electronic 
submissions are not necessary. Should you, however, wish to submit 
written comments in lieu of electronic comments, they must be sent via 
regular or express mail to: Drug Enforcement Administration, Attention: 
DEA Federal Register Representative/ODXL, 8701 Morrissette Drive, 
Springfield, Virginia 22152.

FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record and will be made available for 
public inspection online at http://www.regulations.gov. Such 
information includes personal identifying information (such as your 
name, address, etc.) voluntarily submitted by the commenter.
    The Freedom of Information Act (FOIA) applies to all comments 
received. If you want to submit personal identifying information (such 
as your name, address, etc.) as part of your comment, but do not want 
it to be made publicly available, you must include the phrase 
``PERSONAL IDENTIFYING INFORMATION'' in the first paragraph of your 
comment. You must also place all of the personal identifying 
information you do not want made publicly available in the first 
paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify the 
confidential business information to be redacted within the comment. If 
a comment has so much confidential business information that it cannot 
be effectively redacted, all or part of that comment may not be made 
publicly available. Comments containing personal identifying 
information or confidential business information identified as directed 
above will be made publicly available in redacted form.
    An electronic copy of this document and supplemental information to 
this interim final rule with request for comment are available at 
http://www.regulations.gov for easy reference. If you wish to 
personally inspect the comments and materials received or the 
supporting documentation the DEA used in preparing the interim final 
rule with request for comment, these materials will be available for 
public inspection by appointment. To arrange a viewing, please see the 
For Further Information Contact paragraph above.

Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. Titles II and III are referred to as the ``Controlled 
Substances Act'' and the ``Controlled

[[Page 70086]]

Substances Import and Export Act,'' respectively, and are collectively 
referred to as the ``Controlled Substances Act'' or the ``CSA'' for the 
purpose of this action. 21 U.S.C. 801-971. The DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (CFR), parts 1300 to 1321. The CSA and its 
implementing regulations are designed to prevent, detect, and eliminate 
the diversion of controlled substances and listed chemicals into the 
illicit market while providing for the legitimate medical, scientific, 
research, and industrial needs of the United States. Controlled 
substances have the potential for abuse and dependence and are 
controlled to protect the public health and safety.
    Under the CSA, every controlled substance is classified into one of 
five schedules based upon its potential for abuse, currently accepted 
medical use, and the degree of dependence the drug or other substance 
may cause. 21 U.S.C. 812. The initial schedules of controlled 
substances established by Congress are found at 21 U.S.C. 812(c), and 
the current list of all scheduled substances is published at 21 CFR 
part 1308. Pursuant to 21 U.S.C. 822(a)(1), ``every person who 
manufactures or distributes any controlled substance or list I 
chemical, or who proposes to engage in the manufacture or distribution 
of any controlled substance or list I chemical, shall obtain annually a 
registration issued by the Attorney General in accordance with the 
rules and regulations promulgated by him.'' Further, pursuant to 21 
U.S.C. 822(a)(2), ``every person who dispenses, or who proposes to 
dispense, any controlled substance, shall obtain from the Attorney 
General a registration issued by the Attorney General in accordance 
with the rules and regulations promulgated by him.''
    The Attorney General however may, by regulation, waive the 
requirement for registration of certain manufacturers, distributors, or 
dispensers if he finds it consistent with the public health and safety 
pursuant to 21 U.S.C. 822(d). The Attorney General delegated this 
authority to the Administrator of the DEA, 28 CFR 0.100(b), who in turn 
redelegated that authority to the Deputy Assistant Administrator of the 
DEA Office of Diversion Control (``Deputy Assistant Administrator''). 
Section 7 of 28 CFR part 0, subpart R, App.

Purpose and Background of the Regulatory Action

    On May 10, 1994, the United States Patent and Trademark Office 
issued a patent to GE Healthcare, the sole manufacturer of the 
radioactive drug DaTscan\TM\, for 20 years for the development of 
DaTscan\TM\. On January 14, 2011, the U.S. Food and Drug Administration 
(FDA) approved DaTscan\TM\ as a diagnostic tool containing a 
radioisotopic form of ioflupane, [\123\I]ioflupane. This product is 
approved for medical use and was simultaneously granted exclusive 
marketing rights to GE Healthcare for five years in accordance with 21 
CFR 314.108. Ioflupane is a schedule II controlled substance under the 
CSA.
    The FDA approved labeling of DaTscan\TM\ states that DaTscan\TM\ is 
a radiopharmaceutical indicated for striatal dopamine transporter 
visualization using single photon emission computed tomography (SPECT) 
brain imaging to assist in the evaluation of adult patients with 
suspected Parkinsonian syndromes (PS). DaTscan\TM\ is an adjunct to 
other diagnostic evaluations, and it may be used to help differentiate 
essential tremors from tremors due to PS, (idiopathic Parkinson's 
disease (PD), multiple system atrophy (MSA), and progressive 
supranuclear palsy (PSP)). According to GE Healthcare, DaTscan\TM\ was 
not designed to distinguish among PD, MSA, and PSP. However, the 
results created by the contrast that occurs after the administration of 
DaTscan\TM\ may also be used to help rule out other diseases that may 
have similar symptoms, like essential tremor, for individuals early in 
the course of their disease.
    Because DaTscan\TM\ contains [\123\I]ioflupane, a schedule II 
controlled substance, it may only be handled by entities registered 
with the DEA to handle schedule II controlled substances.\1\ However, 
due to its I-123 radioactive component, the handling of DaTscan\TM\ in 
the United States is also strictly controlled by Federal and State laws 
limiting distribution to licensed radiopharmacies and certain licensed 
medical facilities. It is regulated by the United States Nuclear 
Regulatory Commission (NRC) under 10 CFR part 35 or by an Agreement 
State \2\ under equivalent Agreement State requirements. NRC also 
authorizes certain Federal Agencies (i.e., Master Materials licensees 
(MML)) to issue their medical facilities medical use permits that are 
equivalent to NRC medical use licenses. The NRC and Agreement States 
require those medical facilities administering radioactive medical 
byproduct material to obtain a medical use license or permit and comply 
with specific regulations pertaining to security, recordkeeping, and 
reporting. Id. In accordance with 10 CFR parts 20 and 35 and equivalent 
Agreement State requirements, applicants for NRC and Agreement State 
licensure must comply with and demonstrate radiation safety precautions 
and instructions, methodologies for measurement of dosages to be 
administered, physical security of medical byproduct material, and 
recordkeeping requirements.
---------------------------------------------------------------------------

    \1\ The DEA continues to review the control status of [\123\I] 
Ioflupane pursuant to 21 U.S.C. 811. While this interim final rule 
with request for comment is separate and apart from the control 
process, and does not resolve the control status of [\123\I] 
Ioflupane, this waiver of registration is designed to encourage use 
of this drug product as a diagnostic tool until the control status 
of [\123\I] Ioflupane is resolved.
    \2\ An Agreement State is defined as any State with which the 
Nuclear Regulatory Commission or the Atomic Energy Commission has 
entered into an effective agreement under subsection 274b of the 
Atomic Energy Act of 1954, as amended (the Act). Further, Section 
274 of the Act provides a statutory basis under which the NRC 
discontinues its regulatory authority to regulate byproduct 
materials; source materials; and small quantities of special nuclear 
materials. The Agreement State assumes authority from the NRC with 
its own compatible legislation and regulations, including compatible 
requirements to 10 CFR part 35, once the Agreement is signed in 
accordance with Section 274b of the Act. Agreement States implement 
regulatory programs to regulate byproduct, source and certain 
special nuclear materials that are compatible with NRC requirements 
and adequate to protect public health and safety.
---------------------------------------------------------------------------

    As a result of these overlapping registration/licensing 
requirements, DaTscan\TM\ is available only by authorization from a 
DEA-registered practitioner. Therefore, it may only be administered to 
a patient by physicians authorized under an NRC or an Agreement State 
license or NRC MML permit to perform imaging and localization studies 
under 10 CFR 35.200 or equivalent Agreement State requirements who are 
also registered with the DEA to administer schedule II controlled 
substances. Accordingly, only NRC- or Agreement State-licensed or NRC 
MML permitted radiology imaging centers that are also registered with 
the DEA to handle schedule II controlled substances, such as hospitals 
and private practice imaging centers, may conduct diagnostic analysis 
using DaTscan\TM\.
    Currently, GE Healthcare manufactures DaTscan\TM\ and provides it 
directly to its DEA-registered radiopharmacies, who then transfer it to 
DEA-registered imaging centers for administration and scanning 
procedures. This process occurs in a closed system of distribution that 
is currently regulated by both the DEA and the NRC/Agreement State.

[[Page 70087]]

    In addition to qualifying for registration with the DEA pursuant to 
21 U.S.C. 823(f), practitioners must adhere to controls pertaining to 
physical security, reporting, and recordkeeping, in order to detect and 
prevent diversion of controlled substances. See, e.g., 21 CFR 1301.75-
1301.76, 1304.21-1304.22. For example, DEA-registered pharmacies and 
institutional practitioners may disperse controlled substances 
throughout the stock of non-controlled substances in such a manner as 
to obstruct the theft or diversion of the controlled substances; they 
must also report thefts or significant losses of controlled substances 
to the DEA within one business day of discovery; dispositions of 
schedule II controlled substances must be authorized by a DEA Form 222; 
and they must maintain specified records of each transaction involving 
a controlled substance for a period of two years.
    The NRC and Agreement States require that any person who 
manufactures, produces, acquires, receives, possesses, prepares, uses, 
or transfers radioactive byproduct material for medical use do so only 
in accordance with a specific medical use license issued by the NRC or 
an Agreement State or permit issued by an NRC MML. See 10 CFR 35.11-12. 
Radioisotope I-123 meets the definition of byproduct material in 
paragraph 3B of Section 11e. of the Atomic Energy Act (AEA), as revised 
in 1978 and in 2005 by the Energy Policy Act (EPAct) (i.e., any 
material that has been made radioactive by use of a particle 
accelerator; and is produced, extracted, or converted after extraction, 
before, on, or after August 8, 2005, for use for a commercial, medical, 
or research activity).
    The NRC and Agreement States regulate licensed materials (i.e., 
byproduct material) which must be tracked from initial production to 
final disposal in order to ensure accountability; to identify when 
licensed material could be lost, stolen, or misplaced; and to ensure 
that possession limits listed on the license are not exceeded.
    In accordance with 10 CFR 20.1101, licensees are required to 
implement a radiation protection program that requires licensees to 
develop, document, and implement procedures to ensure the security and 
safe use of all the licensed material from the time it arrives at their 
facilities until it is used, transferred, or disposed of. The DEA 
regulations require practitioners to ``provide effective controls and 
procedures to guard against theft and diversion of controlled 
substances.'' 21 CFR 1301.71(a). In addition, in accordance with 21 CFR 
1301.75(b), practitioners must store schedule II controlled substances 
in a securely locked, substantially constructed cabinet. However, 
pharmacies and institutional practitioners (e.g., hospitals) 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.'' Id.
    The NRC and Agreement States also require distributor-licensees to 
verify the licensure status of each recipient prior to transferring 
radioactive byproduct material each time it is transferred. See 10 CFR 
30.41. In contrast to the NRC/Agreement State regulations and licensure 
requirements, the DEA in accordance with 21 CFR 1301.74(a) has mandated 
that ``before distributing a controlled substance to any person who the 
registrant does not know to be registered to possess the controlled 
substance, the registrant shall make a good faith inquiry either with 
the Administration or with the appropriate State controlled substances 
registration agency, if any, to determine that the person is registered 
to possess the controlled substance.''
    The NRC and Agreement States also require licensees to comply with 
recordkeeping requirements for three years from the date of receipt and 
to provide the NRC with accurate records for the receipt, transfer, and 
disposal of the byproduct material in accordance with 10 CFR 30.51. 
This is more stringent than the DEA regulations, which require 
registrants to maintain records for a period of two years for 
inspection and copying by the DEA. See 21 CFR 1304.04(a).
    With this interim final rule, the DEA is only waiving registration 
requirements specifically for persons administering DaTscan\TM\ 
directly to patients for diagnostic purposes.\3\ Persons administering 
the specific drug product DaTscan\TM\ are exempt from requirements 
pertaining to registration, security, recordkeeping, and reporting. In 
addition, the drug product DaTscan\TM\ is exempt from the labeling and 
packaging requirements of the CSA. Exempt persons must follow the 
applicable NRC or Agreement State regulations and requirements when 
handling DaTscan\TM\.
---------------------------------------------------------------------------

    \3\ Persons that handle other controlled substances in addition 
to DaTscan\TM\ must be registered with the DEA to handle those other 
controlled substances.
---------------------------------------------------------------------------

    Because persons who administer DaTscan are subject to strict NRC/
Agreement State requirements, the DEA has determined that the waiver 
from registration of persons who administer DaTscan\TM\ is consistent 
with the public health and safety. These exempt persons must be 
authorized by a valid NRC or Agreement State medical use license or NRC 
MML medical use permit for imaging or localization studies under 35.200 
or equivalent Agreement State requirements and be subject to security, 
oversight, and monitoring that is as stringent as that provided by the 
CSA and its implementing regulations. Compliance with NRC or Agreement 
State requirements significantly reduces the risk of diversion, thereby 
ensuring that the public health and safety will not be compromised by 
this waiver.
    Finally, in accordance with the AEA disposal requirements in 10 CFR 
20.2002 through 20.2005, the licensee is required to dispose of the 
radioactive medical waste while complying with environmental and health 
protection regulations. Since DaTscan\TM\ has a radiologic shelf life 
of less than 36 hours, it cannot be stored for any significant amount 
of time between the time it is manufactured and the time it is 
administered to a patient, thereby minimizing the risk of diversion 
during the transfer process and decreasing the time to detect theft or 
loss. Accordingly, those persons waived from registration and other 
requirements by this interim final rule (i.e., those persons 
administering DaTscan\TM\ directly to patients for diagnostic purposes) 
will be also exempted from the disposal requirements of 21 CFR part 
1317, and the manufacturers and distributors of DaTscan\TM\ will be 
required to comply with the DEA disposal regulations (21 CFR part 1317) 
in order to ensure that any drug product that is not administered or 
that remain after administration is not diverted to illicit use.
    Under this interim final rule, a DEA-registered practitioner must 
prepare a record containing the practitioner's name and signature, DEA 
registration number, drug product name, date the record was signed, and 
patient name, and provide this record to the patient. The record must 
be transferred by the patient to the imaging center. The imaging center 
will then request the drug product DaTscan\TM\ from the DEA-registered 
distributor by providing the written record as authorization to 
transfer the drug product. The DEA-registered distributor shall 
maintain this document as the record of the transaction. The DEA-
registered distributor will verify that the imaging center has a 
current, valid NRC or Agreement State medical use license or

[[Page 70088]]

NRC MML medical use permit that authorizes imaging and localization and 
if it does, the distributor will then request the drug product 
DaTscan\TM\ from the manufacturer. After receipt of the drug product 
DaTscan\TM\ from the manufacturer, the distributor will transfer the 
ordered amount of the drug product DaTscan\TM\ to the imaging center 
for the test. The DaTscan\TM\ will be administered to the patient, and 
the test will be performed. Any DaTscan\TM\ that is not administered or 
that remains after the administration will then be returned to the 
distributor by the licensee and subsequently disposed of in accordance 
with the DEA disposal regulations. Both the DEA-registered distributor 
and the DEA-registered manufacturer must comply with all DEA 
regulations pertaining to schedule II controlled substances including 
security, registration, and recordkeeping.

Regulatory Analyses

Executive Orders 12866 and 13563

    This interim final rule, which waives registration for persons 
authorized under United States Nuclear Regulatory Commission or 
Agreement State medical use licenses or NRC MML medical use permits, 
who administer the drug product DaTscan\TM\ directly to patients for 
diagnostic purposes, has been drafted and reviewed in accordance with 
Executive Order 12866, ``Regulatory Planning and Review'' section 1(b), 
Principles of Regulation, and in accordance with Executive Order 13563 
``Improving Regulation and Regulatory Review'' section 1(b) General 
Principles of Regulation.
    The Department of Justice has determined that this rule is not a 
``significant regulatory action'' under Executive Order 12866, section 
3(f), Regulatory Planning and Review, and accordingly this rule has not 
been reviewed by the Office of Management and Budget.
    Further, both Executive Orders 12866 and 13563 direct agencies to 
assess all costs and benefits of available regulatory alternatives and, 
if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health and safety effects, distributive impacts, and equity). 
Executive Order 13563 emphasizes the importance of quantifying both 
costs and benefits, of reducing costs, of harmonizing rules, and of 
promoting flexibility. The DEA assessed the costs and benefits of this 
regulation and believes that the regulatory approach selected maximizes 
net benefits.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform 
to eliminate drafting errors and ambiguity, minimize litigation, 
provide a clear legal standard for affected conduct, and promote 
simplification and burden reduction.

Executive Order 13132

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The proposed rule does not 
have substantial direct effects on the States, on the relationship 
between the national government and the States, or the distribution of 
power and responsibilities among the various levels of government.

Executive Order 13175

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Regulatory Flexibility Act

    The Deputy Assistant Administrator, in accordance with the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), has reviewed this 
regulation and by approving it certifies that this regulation will not 
have a significant economic impact on a substantial number of small 
entities. The RFA applies ``[w]henever an agency is required by section 
553 of [the APA], or any other law, to publish a general notice of 
proposed rulemaking for any proposed rule.'' 5 U.S.C. 603. Here, the 
DEA for good cause finds that notice and comment procedures are 
unnecessary and contrary to the public interest because without prompt 
waiver of registration, some members of the healthcare community may 
not be able to utilize the diagnostic tool. Accordingly, these rules 
are being adopted on an interim final basis. Additionally, this interim 
final rule is alleviating regulatory restrictions on those affected by 
its implementation.
    Although, the DEA does not have a basis to estimate the number of 
affected entities and quantify the economic impact of this interim 
final rule, a qualitative analysis indicates that this interim final 
rule is likely to result in some cost savings for the healthcare 
industry. The affected entities will continue to meet NRC or Agreement 
State requirements for licensure, security, recordkeeping, and 
reporting, which in many cases are more stringent than the DEA's 
requirements. The DEA estimates cost savings will be realized from the 
removal of DEA requirements for those administering the drug product 
DaTscan\TM\ that are duplicative of NRC or Agreement State 
requirements, such as: Registration fees, recordkeeping, and periodic 
reports. While the DEA does estimate that this interim final rule will 
provide some cost savings, it does not believe the savings will be 
significant since the affected entities are required to continue to 
meet NRC requirements for handling DaTscan\TM\.

Paperwork Reduction Act of 1995

    This rule does not involve a collection of information within the 
meaning of the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3521.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995 
(2 U.S.C. 1501 et seq.), the DEA has determined and certifies pursuant 
to UMRA that this action would not result in any Federal mandate that 
may result ``in the expenditure by State, local, and tribal 
governments, in the aggregate, or by the private sector, of $100 
million or more (adjusted for inflation) in any one year * * *.'' 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under the provisions of UMRA of 1995.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act (CRA) (5 U.S.C. 804). This rule will not result in an annual 
effect on the economy of $100,000,000 or more, a major increase in 
costs or prices, or have significant adverse effects on competition, 
employment, investment, productivity, innovation, or the ability of 
United States-based companies to compete with foreign-based companies 
in domestic and export markets. However, pursuant to the CRA, the DEA 
has submitted a copy of this interim final rule with request for 
comment to both Houses of Congress and to the Comptroller General.

Administrative Procedure Act

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (APA), including notice 
of proposed rulemaking and the pre-promulgation opportunity for public 
comment, if it is determined to be unnecessary,

[[Page 70089]]

impracticable, or contrary to the public interest (5 U.S.C. 553 
(b)(B)). The DEA for good cause finds that it is unnecessary and 
contrary to the public interest to seek public comment prior to 
promulgating this interim final rule because, without prompt waiver of 
registration, some members of the healthcare community may not be able 
to utilize this diagnostic tool and patients in need may not receive 
it. DaTscan\TM\ is an important tool in differentiating essential 
tremors from tremors due to Parkinsonian Syndrome (PS) and can help 
healthcare professionals provide more accurate diagnoses. These rules 
are therefore, being adopted on an interim final basis. Additionally, 
the DEA is alleviating the regulatory burdens on those administering 
the drug product DaTscan\TM\. Furthermore, this alleviation will mean 
that patients have a greater chance of receiving important diagnostic 
testing.
    In addition, the APA permits an agency to make effective upon date 
of publication ``a substantive rule which grants or recognizes an 
exemption or relieves a restriction.'' 5 U.S.C. 553 (d)(1). The DEA 
finds that this interim final rule with request for comments meets the 
criterion set forth in 5 U.S.C. 553 (d)(1) for an exception to the APA 
effective date requirement.

List of Subjects in 21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Controlled substances, Drug abuse, Reporting and recordkeeping 
requirements.

    For the reasons set out above, 21 CFR part 1301 is amended as 
follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1301 continues to read as 
follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958, unless otherwise noted.


0
2. Add a new Sec.  1301.29 to read as follows:


Sec.  1301.29  Registration waivers; exemption from practitioner 
registration for persons authorized by a United States Nuclear 
Regulatory Commission or agreement state medical use license or permit 
and administering the drug product DaTscan\TM\

    (a) The requirement of registration is waived for persons 
administering the drug product DaTscan\TM\ to a patient for diagnostic 
purposes if the person is authorized by a valid medical use license or 
permit issued by the United States Nuclear Regulatory Commission (NRC) 
or NRC master materials licensee or an agreement state authorizing the 
person to receive, possess, use, or transfer byproduct material in 
accordance with NRC or agreement state rules and regulations.
    (1) As used in this section, ``agreement state'' is any state with 
which the NRC or the Atomic Energy Commission has entered into an 
effective agreement under Section 274(b) of the Atomic Energy Act of 
1954, as amended. As of October 2014, those states considered ``non-
agreement states'' include: Alaska, Connecticut, Delaware, Hawaii, 
Idaho, Indiana, Michigan, Missouri, Montana, South Dakota, Vermont, 
Washington, DC, West Virginia, and Wyoming. All other states have 
entered into agreements with the NRC.
    (2) This section does not exempt persons identified in this 
paragraph (a) from any statutory or regulatory requirements pertaining 
to any controlled substance other than the drug product DaTscan\TM\.
    (3) This section does not exempt from the requirement of 
registration persons who prescribe, or order the administration of, the 
drug product DaTscan\TM\.
    (b) Persons identified in paragraph (a) of this section are exempt 
from application of 21 U.S.C. 822(a)(2), 827, and 828 (registration, 
records, reports, and order forms) and sections 1301.71, 1301.75, and 
1301.76 of this chapter (practitioner security), to the extent 
described in paragraphs (e) and (f) of this section, only with respect 
to administering the drug product DaTscan\TM\.
    (c) The drug product DaTscan\TM\ is exempt from application of 21 
U.S.C. 825 and Sec.  1302.03 of this chapter to the extent described in 
paragraph (d) of this section.
    (d) Labeling and packaging. In lieu of the requirements set forth 
in part 1302 of this chapter, the label and the packaging of the drug 
product DaTscan\TM\ must be prominently marked with its full trade name 
or other description and the name of the manufacturer in such a way 
that the product can be readily identified as the drug product 
DaTscan\TM\. The symbol designating the schedule of the drug product 
DaTscan\TM\ is not required on either the label or the packaging of the 
drug product DaTscan\TM\.
    (e) Registration and security. Any person who manufactures or 
distributes the drug product DaTscan\TM\ must be registered under the 
Act and comply with all relevant security requirements regarding the 
schedule II controlled substances being distributed or used in the 
manufacturing process. Any person identified in paragraph (a) of this 
section is not required to be registered under the Act to handle the 
drug product DaTscan\TM\, and these persons are not required to store 
the drug product DaTscan\TM\ in accordance with security requirements 
regarding controlled substances.
    (f) Records and reports. Any person who manufactures or distributes 
the drug product DaTscan\TM\ must keep complete and accurate records 
and file all reports required under part 1304 of this chapter regarding 
all controlled substances distributed or used in the manufacturing 
process for the drug product DaTscan\TM\. In reports required by 21 CFR 
1304.33 due to transactions with persons identified in paragraph (a) of 
this section, the DEA registration number of the person identified in 
paragraph (a) is not required to be reported. Any person identified in 
paragraph (a) who handles the drug product DaTscan\TM\ is not required 
to maintain records or file reports required by the Act or its 
implementing regulations. The authorizing practitioner shall prepare a 
record containing the practitioner's name, signature, date of 
authorization, DEA registration number, drug product name, and patient 
name, and provide this record to the patient. This record prepared by 
the DEA registered practitioner shall be used as the distributor's 
record of the distribution.
    (g) Criminal penalties No exemption granted pursuant to this 
section affects the criminal liability for illegal manufacture, 
distribution, or possession of controlled substances contained in the 
drug product DaTscan\TM\. Use of the drug product DaTscan\TM\ is lawful 
for registrants and nonregistrants only as long as such activity is 
intended for administration for diagnostic purposes.
    (h) The persons identified in paragraph (a) of this section shall 
return all unused drug product DaTscan\TM\ to the DEA-registered 
distributor from whom the person received it, for disposal in 
accordance with 10 CFR 20.2001-20.2008.
    (i) Once the drug product DaTscan\TM\ is returned to the 
appropriate DEA-registered distributor, it shall be disposed of in 
accordance with the following procedures:
    (1) The DEA-registered distributor shall keep a record of the 
return;
    (2) After receipt of the drug product DaTscan\TM\, the DEA-
registered distributor shall hold the drug product DaTscan\TM\ until it 
is no longer considered low-level radioactive waste

[[Page 70090]]

in accordance with 10 CFR 20.2001(a)(2); and
    (3) After the drug product DaTscan\TM\ is no longer considered low-
level radioactive waste, the DEA-registered distributor shall dispose 
of all unused DaTscan\TM\ in accordance with 21 CFR part 1317.
    (j) The exemptions specified in this section are not applicable to 
the drug product DaTscan\TM\ if there are any changes in the 
quantitative or qualitative composition of the preparation or mixture 
after the date of this regulation, or change in the trade name or other 
designation of the drug product DaTscan\TM\.

    Dated: November 18, 2014.
Joseph T. Rannazzisi,
Deputy Assistant Administrator.
[FR Doc. 2014-27917 Filed 11-24-14; 8:45 am]
BILLING CODE 4410-09-P