[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]
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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 DaTscanTM
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Interim final rule with request for comment.
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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.
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\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.
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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\.
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\3\ Persons that handle other controlled substances in addition
to DaTscan\TM\ must be registered with the DEA to handle those other
controlled substances.
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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