[Federal Register: January 4, 2005 (Volume 70, Number 2)]
[Rules and Regulations]
[Page 291-294]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja05-7]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1304, 1306, and 1310
[Docket No. DEA-234F]
RIN 1117-AA71
Recordkeeping and Reporting Requirements for Drug Products
Containing Gamma-Hydroxybutyric Acid (GHB)
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule.
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SUMMARY: DEA is amending its regulations to require additional
recordkeeping and reporting requirements for drug products containing
gamma-hydroxybutyric acid (GHB) for which an application has been
approved under the Federal Food, Drug, and Cosmetic Act. DEA makes
these changes under section 4 of the ``Hillory J. Farias and Samantha
Reid Date-Rape Drug Prohibition Act of 2000.'' These additional
requirements are necessary to protect against the diversion of GHB for
illicit purposes.
EFFECTIVE DATE: February 3, 2005.
FOR FURTHER INFORMATION CONTACT: Patricia M. Good, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537. Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
Controlled Substances and Listed Chemicals
Controlled substances are drugs that have a potential for abuse and
addiction; these include opiates, stimulants, depressants,
hallucinogens, anabolic steroids, and substances that are immediate
precursors to these controlled substances. Controlled substances are
listed in 21 CFR part 1308. The substances are divided into five
schedules. Schedule I substances are drugs for which there is a high
potential for abuse, no currently accepted medical treatment in use in
the United States, and lack accepted safety for use under medical
supervision. Schedule II-V substances have accepted medical uses, but
have a potential for abuse and may lead to physical and psychological
dependence. Such drugs are subject to varying levels of control.
Chemicals that can be used to manufacture controlled substances are
regulated as either List I chemicals (important to the manufacture) or
List II chemicals (used in the manufacture) of controlled substances.
Background
Gamma-Hydroxybutyric acid (GHB) is a central nervous system
depressant drug. In recent years, the abuse of GHB has increased
substantially. GHB is abused for its euphoric and purported
hallucinogenic effects, as well as for its alleged role as an agent to
stimulate muscle growth. GHB can produce drowsiness, dizziness, nausea,
visual disturbances, unconsciousness, seizures, severe respiratory
depression, coma, and death.
GHB can be produced in clandestine laboratories using a relatively
simple synthesis with readily available and inexpensive source
materials. Gamma-Butyrolactone (GBL), a List I chemical, is an
industrial chemical that is used in the illicit manufacture of GHB. GBL
and 1,4-butanediol, another industrial chemical, are also abused for
their GHB-like effects. Due to their structural and pharmacological
similarities to GHB, GBL and 1,4-butanediol are considered controlled
substance analogues as defined by 21 U.S.C. 802(32). Manufactured GHB
usually results in a clear solution that can be disguised by adding
food coloring, flavorings, or storing it in different kinds of bottles
and containers.
The listed chemical GBL has many industrial applications, and has
not been scheduled at this time to prevent an undue regulatory burden
to legitimate commerce in this substance. Because GBL is a controlled
substance analogue, individuals who manufacture or distribute or
possess with intent to manufacture or distribute this chemical
intending it for human consumption may be prosecuted under provisions
of the Controlled Substances Act. This is
[[Page 292]]
because a controlled substance analogue which is intended for human
consumption is treated as a Schedule I controlled substance. When
handled for industrial purposes, with no intent for human consumption,
it is not treated as a Schedule I controlled substance and those
handling it are not subject to any Schedule I controlled substances
penalties under the Controlled Substances Act.
Regulatory History
On February 18, 2000, the ``Hillory J. Farias and Samantha Reid
Date-Rape Drug Prohibition Act of 2000'' was enacted (Pub. L. 106-172,
114 Stat. 7). Public Law 106-172 declared GHB an imminent hazard to
public safety that required immediate regulatory action under the
Controlled Substances Act. Public Law 106-172 required the Attorney
General to list GHB as a Schedule I controlled substance and designated
GBL as a List I chemical. As a result of the Hillory J. Farias and
Samantha Reid Date-Rape Drug Prohibition Act, DEA issued two final
rules: Schedules of Controlled Substances: Addition of Gamma-
Hydroxybutyric Acid to Schedule I (65 FR 13235, March 13, 2000)
(corrected at 65 FR 17440, April 3, 2000) and Placement of Gamma-
Butyrolactone in List I of the Controlled Substances Act (21 U.S.C.
802(34)) (65 FR 21645, April 24, 2000).
Under the March 13, 2000 final rule, GHB and its salts, isomers,
and salts of isomers were placed in Schedule I, and GHB became subject
to the regulatory controls and administrative, civil, and criminal
sanctions applicable to the manufacture, distribution, dispensing,
importing, and exporting of a Schedule I controlled substance. As
required by the Hillory J. Farias and Samantha Reid Date-Rape Drug
Prohibition Act, the March 13, 2000 final rule created an exception for
drug products containing GHB, including its salts, isomers, and salts
of isomers, for which an application is approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 355). The
exception placed any such drug products--there were none approved at
the time the legislation was passed--in Schedule III. Therefore,
registered manufacturers and distributors of FDA-approved drug products
containing GHB are subject to Schedule III regulatory requirements.
However, criminal penalties for unlawful distributions of these drug
products are those for Schedule I controlled substances.
On July 17, 2002, the Food and Drug Administration (FDA) approved
Xyrem, a drug product containing gamma-hydroxybutyric acid, as a drug
for the treatment of cataplexy associated with narcolepsy.
Notice of Proposed Rulemaking
The March 13, 2000 final rule did not address the recordkeeping and
reporting requirements recommended by the Hillory J. Farias and
Samantha Reid Date-Rape Drug Prohibition Act for drug products
containing GHB for which an application is approved under section 505
of the FDCA. On November 25, 2003 DEA issued a notice of proposed
rulemaking (68 FR 66048) to establish requirements to prevent the
diversion of Schedule III GHB drug products for illicit purposes as was
intended by Congress as part of the regulatory scheme for these
products. DEA received no comments in response to the November 25, 2003
notice of proposed rulemaking and is adopting the rule language as
proposed.
In response to section 4 of the Hillory J. Farias and Samantha Reid
Date-Rape Drug Prohibition Act, this rule establishes recordkeeping
requirements for practitioners dispensing Schedule III GHB drug
products and reporting requirements for manufacturers and distributors
of Schedule III GHB drug products. Under existing 21 CFR 1304.22(c),
dispensers of any controlled substance, including GHB, are required to
maintain the name and address of the person to whom the controlled
substance 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. This final rule adds 21 CFR 1304.26, which requires
pharmacies and practitioners dispensing GHB to maintain and make
available for inspection the name of the prescribing practitioner, the
prescribing practitioner's Federal and State registration numbers with
expiration dates, verification that the prescribing practitioner
possesses appropriate registration, and the patient's insurance
provider, if available. Section 4 of the Hillory J. Farias and Samantha
Reid Date-Rape Drug Prohibition Act also recommended that DEA establish
a recordkeeping requirement for ``documentation by a medical
practitioner licensed and registered to prescribe the drug of the
patient's medical need for the drug.'' Part of this recommendation is
satisfied by existing DEA requirements in 21 CFR 1306.04 which state
that prescriptions ``must be issued for a legitimate medical purpose.''
To further satisfy this statutory requirement, DEA has amended 21 CFR
1306.05 to require that the medical need be written on the
prescription.
This final rule also amends 21 CFR 1304.33 to include Schedule III
GHB drug products as controlled substances that must be reported under
the Automation of Reports and Consolidated Orders System (ARCOS). ARCOS
is an automated, comprehensive drug reporting system that monitors the
flow of DEA controlled substances from their point of manufacture
through commercial distribution channels to point of sale or
distribution at the dispensing/retail level, e.g., hospitals, retail
pharmacies, practitioners, mid-level practitioners, and teaching
institutions. Included in the list of controlled substance transactions
tracked by ARCOS are the following: All Schedules I and II materials
(manufacturers and distributors); Schedule III narcotic materials
(manufacturers and distributors); and selected Schedules III and IV
psychotropic controlled substances (manufacturers only). This final
rule adds Schedule III GHB drug products to this list for both
manufacturers and distributors.
In addition, section 4 of the Hillory J. Farias and Samantha Reid
Date-Rape Drug Prohibition Act recommended that DEA apply the mail
order reporting requirements of 21 U.S.C. 830(b)(3) to ``gamma
hydroxybutyric acid to the same extent and in the same manner as such
section applies with respect to the chemicals and drug products
specified in subparagraph (B)(i) of such section.'' DEA has complied
with these recommendations in this final rule by amending 21 CFR
1310.03(c), which makes GHB subject to mail order requirements
established under the Methamphetamine Anti-Proliferation Act of 2000
(MAPA) (Title XXXVI of the ``Children's Health Act of 2000'' (Pub. L.
106-310, 114 Stat. 1101)). The Methamphetamine Anti-Proliferation Act
of 2000 imposed mail order reporting requirements for export
transactions involving ephedrine, pseudoephedrine, or
phenylpropanolamine. These reporting requirements do not apply to
distributions of drug products, including GHB, under a valid
prescription, which were excluded under MAPA (21 U.S.C. 830(b)(3)(D)).
Regulations implementing MAPA were published October 7, 2003 (68 FR
57799). The net effect is that all export transactions involving GHB
must be reported to DEA. Transactions involving prescriptions of GHB
are not required to be reported to DEA.
[[Page 293]]
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator certifies that this rulemaking
has been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 605(b)). The Deputy Assistant Administrator has reviewed this
regulation, and by approving it certifies that it will not have a
significant economic impact upon a substantial number of small
entities. This rulemaking creates new recordkeeping and reporting
requirements which will have an extremely limited impact on a small
number of registrants due to the restricted use of GHB for legitimate
medical purposes. As a condition of Xyrem's (the FDA-approved product
containing GHB) approval, a risk management program was designed to
limit its distribution. Under this program, Xyrem will only be
available to physicians and patients through a single centralized
pharmacy. As a result of this program, at this time, controlled
substance distributors and retail pharmacies will not be handling Xyrem
and, thus, will not be affected by these requirements. For those few
persons affected by these regulations, the information requested by
these added records is readily and commonly available, and due to the
limited distribution of GHB, the impact on reporting requirements
should be minimal.
Executive Order 12866
The Deputy Assistant Administrator further certifies that this
regulation has been drafted in accordance with the principles of
Executive Order 12866, Section 1(b). This action has been determined to
be a ``significant regulatory action'' under Executive Order 12866, and
accordingly this rule has been reviewed by the Office of Management and
Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988.
Executive Order 13132
This rulemaking does not preempt or modify any provision of State
law; nor does it impose enforcement responsibilities on any State; nor
does it diminish the power of any State to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rulemaking will not result in the expenditure by State, local,
and tribal governments in the aggregate, or by the private sector, of
$114.5 million or more in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Paperwork Reduction Act
While, technically, this rule requires new, minimal recordkeeping
and reporting requirements for drug products containing GHB, DEA does
not believe that these recordkeeping and reporting requirements create
any greater hour or cost burden for respondents than what already
exists. Records required to be maintained by dispensing practitioners
under 21 CFR 1304.26, including the prescribing practitioner's name,
address, state license and federal registration numbers, and the
patient's insurance provider (if available) are all records which are
maintained as a usual course of professional practice by a dispensing
practitioner. The reporting requirements in 21 CFR 1304.33 are part of
an already-approved collection of information (OMB 1117-0003: ARCOS
Transaction Reporting--DEA Form 333). DEA believes that the additional
reporting requirements will have no impact on the hour or cost burden
for respondents as reports are generated and submitted electronically.
As has been stated previously, due to the risk management plan
established for Xyrem (the FDA-approved drug product containing GHB)
this product has an extremely limited distribution potential. Because
of the nature of this product's distribution, DEA anticipates that
fewer than five persons will be impacted by the requirement to report
handling Schedule III GHB products to ARCOS, and those persons are
already filing reports with DEA for other controlled substances
handled. The system modifications necessary to generate this report
will occur as a normal part of a registrant's handling of this product.
Therefore, DEA is not submitting any changes or amendments to its
active information collections under the Paperwork Reduction Act of
1995.
Small Business Regulatory Enforcement Fairness Act of 1996
This rulemaking is not a major rule as defined by section 804 of
the Small Business Regulatory Enforcement Fairness Act of 1996. This
rule will not result in an annual effect on the economy of $100 million
or more; a major increase in costs or prices; or significant adverse
effects on competition, employment, investment, productivity,
innovation or on the ability of U.S.-based companies to compete with
foreign-based companies in domestic and export markets.
List of Subjects
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1306
Drug traffic control, Prescription drugs.
21 CFR Part 1310
Drug traffic control, List I and List II chemicals, Reporting and
recordkeeping requirements.
0
For the reasons set out above, 21 CFR parts 1304, 1306, and 1310 are
amended as follows:
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
1. The authority citation for 21 CFR part 1304 continues to read as
follows:
Authority: 21 U.S.C. 821, 827, 871(b), 958, 965, unless
otherwise noted.
0
2. Section 1304.22 is amended by revising paragraph (c) to read as
follows:
Sec. 1304.22 Records for manufacturers, distributors, dispensers,
researchers, importers and exporters.
* * * * *
(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. In addition to
the requirements of this paragraph, practitioners dispensing gamma-
hydroxybutyric acid under a prescription must also comply with Sec.
1304.26.
* * * * *
0
3. Section 1304.26 is added to read as follows:
[[Page 294]]
Sec. 1304.26 Additional recordkeeping requirements applicable to drug
products containing gamma-hydroxybutyric acid.
In addition to the recordkeeping requirements for dispensers and
researchers provided in Sec. 1304.22, practitioners dispensing gamma-
hydroxybutyric acid that is manufactured or distributed in accordance
with an application under section 505 of the Federal Food, Drug, and
Cosmetic Act must maintain and make available for inspection and
copying by the Attorney General, all of the following information for
each prescription:
(a) Name of the prescribing practitioner.
(b) Prescribing practitioner's Federal and State registration
numbers, with the expiration dates of these registrations.
(c) Verification that the prescribing practitioner possesses the
appropriate registration to prescribe this controlled substance.
(d) Patient's name and address.
(e) Patient's insurance provider, if available.
0
4. Section 1304.33 is amended by revising paragraph (c) and the
introductory text of paragraph (d)(1) to read as follows:
Sec. 1304.33 Reports to ARCOS.
* * * * *
(c) Persons reporting. For controlled substances in Schedules I,
II, narcotic controlled substances in Schedule III, and gamma-
hydroxybutyric acid drug product 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, including each person who is registered to
reverse 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, gamma-hydroxybutyric acid drug
product controlled substances in Schedule III, and on each psychotropic
controlled substance listed in Schedules 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, 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), and on gamma-
hydroxybutyric acid drug products listed in Schedule III. Additionally,
reports on manufacturing transactions shall include the following
psychotropic controlled substances listed in Schedules III and IV:
* * * * *
PART 1306--PRESCRIPTIONS
0
5. The authority citation for part 1306 continues to read as follows:
Authority: 21 U.S.C. 821, 829, 871(b) unless otherwise noted.
0
6. Section 1306.05 is amended by revising paragraph (a) to read as
follows:
Sec. 1306.05 Manner of issuance of prescriptions.
(a) All prescriptions for controlled substances shall be dated as
of, and signed on, the day when issued and shall bear the full name and
address of the patient, the drug name, strength, dosage form, quantity
prescribed, directions for use and the name, address and registration
number of the practitioner. Where a prescription is for gamma-
hydroxybutyric acid, the practitioner shall note on the face of the
prescription the medical need of the patient for the prescription. A
practitioner may sign a prescription in the same manner as he would
sign a check or legal document (e.g., J.H. Smith or John H. Smith).
Where an oral order is not permitted, prescriptions shall be written
with ink or indelible pencil or typewriter and shall be manually signed
by the practitioner. The prescriptions may be prepared by the secretary
or agent for the signature of a practitioner, but the prescribing
practitioner is responsible in case the prescription does not conform
in all essential respects to the law and regulations. A corresponding
liability rests upon the pharmacist, including a pharmacist employed by
a central fill pharmacy, who fills a prescription not prepared in the
form prescribed by DEA regulations.
* * * * *
PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN
MACHINES
0
7. The authority citation for part 1310 is revised to read as follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b) 890.
0
8. Section 1310.03 is amended by revising paragraph (c) to read as
follows:
Sec. 1310.03 Persons required to keep records and file reports.
* * * * *
(c) Each regulated person who engages in a transaction with a
nonregulated person or who engages in an export transaction that
involves ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid, including drug products containing these
chemicals, and uses or attempts to use the Postal Service or any
private or commercial carrier must file monthly reports of each such
transaction as specified in Sec. 1310.05 of this part.
Dated: December 22, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 05-56 Filed 1-3-05; 8:45 am]
BILLING CODE 4410-09-P