[Federal Register Volume 68, Number 227 (Tuesday, November 25, 2003)]
[Proposed Rules]
[Pages 66048-66052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29336]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1304, 1306, and 1310
[Docket No. DEA-234P]
RIN 1117-AA71
Recordkeeping and Reporting Requirements for Drug Products
Containing Gamma-Hydroxybutyric Acid (GHB)
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: DEA proposes to amend 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 proposes
[[Page 66049]]
these changes pursuant to 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.
DATES: Comments must be postmarked by January 26, 2004.
ADDRESSES: Comments should be submitted to the Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration, Washington, DC 20537, Attention: DEA Federal Register
Representative/CCR.
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:
What Is Gamma-Hydroxybutyric Acid?
Gamma-hydroxybutyric acid (GHB) is a central nervous system
depressant drug. In recent years, the abuse of GHB has increased
substantially. GHB is abused to produce euphoric and hallucinogenic
states, and for its alleged role as an agent to stimulate muscle
growth. GHB can produce drowsiness, dizziness, nausea, visual
disturbances, unconsciousness, seizures, severe respiratory depression,
and coma.
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 solvent that is used in the illicit manufacture of GHB. GBL
and 1,4-butanediol are also abused for their GHB-like effects. Due to
their structural and pharmacological similarities to GHB, GBL and 1,4-
butanediol may be considered controlled substance analogs and treated
as Schedule I substances if they are intended for human consumption.
GHB is usually manufactured in a clear solution that can be disguised
by adding food coloring, flavorings, and/or storing it in different
kinds of bottles and containers.
Regulatory History
On February 18, 2000, Public Law 106-172 (114 Stat. 7) the
``Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of
2000'' was enacted. Pub. L. 106-172 declared GHB an imminent hazard to
public safety that requires immediate regulatory action under the
Controlled Substances Act. Pub. L. 106-172 requires the Attorney
General to list GHB as a Schedule I controlled substance and designates
GBL as a List I chemical. As a result of Pub. L. 106-172, 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 Pub. L. 106-172, 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 (FFDCA).
The exception placed these substances in Schedule III. Therefore,
registered manufacturers and distributors of FDA-approved Drugs
containing GHB are subject to Schedule III requirements.
On July 17, 2002, the Food and Drug Administration (FDA) approved
Xyrem'', a drug containing gamma-hydroxybutyric acid, as a Schedule III
controlled substance for the treatment of cataplexy associated with
narcolepsy.
Additional Recordkeeping and Reporting Requirements Proposed for
Schedule III GHB Drug Products
The March 13, 2000 final rule did not address the recordkeeping and
reporting requirements recommended by Public Law 106-172 for drug
products containing GHB, for which an application is approved under
section 505 of the FFDCA. The additional requirements are necessary to
prevent the diversion of Schedule III GHB drug products for illicit
purposes and were intended by Congress to be part of the regulatory
scheme for these products. Representative Thomas Bliley explained
Congress' intent in legislating these requirements as follows:
Also, under H.R. 2130, as amended, if a drug product that
contains GHB receives FDA approval, the approved GHB drug product
will be placed in Schedule III of the CSA. However, given the
dangers involving this drug, H.R. 2130 adds additional reporting and
accountability requirements to conform with the requirements for
schedule I substances, schedule II drugs, and schedule III
narcotics, and, significantly would maintain the strict schedule I
criminal penalties for the unlawful abuse of the approved drug
product. Simply put, these additional requirements and penalties in
my opinion are needed to provide greater protection to our nation's
youth, and to give our law enforcement agencies the ability to
penalize those who abuse this product to the fullest extent under
the law.(Mr. Bliley, Cong. Record Jan. 31, 2000, H61)
In response to Public Law 106-172, Section 4, this rule proposes
recordkeeping requirements for practitioners dispensing Schedule III
GHB drug products and reporting requirements for manufacturers and
distributors of Schedule III GHB drug products. Under current 21 CFR
1304.22(c) dispensers of GHB, including pharmacies, are required to
maintain 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 these requirements, proposed 21 CFR 1304.26 would require
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. Pub. L. 106-172, Section 4 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 currently 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 requirement, DEA is
proposing the amendment of 21 CFR 1306.05 to require that the medical
need be written on the prescription.
This rule also proposes to amend 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, which
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
[[Page 66050]]
(manufacturers and distributors); Schedule III narcotic materials
(manufacturers and distributors); and selected Schedules III and IV
psychotropic controlled substances (manufacturers only). This proposal
would add Schedule III GHB drug products to this list.
In addition, Public Law 106-172, Section 4 (amending 21 U.S.C.
827(h)(6)) 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
(A)(i) of such section.'' While DEA is proposing the amendment of its
regulations to include these provisions, Congress also passed Pub. L.
106-310, the ``Children's Health Act of 2000'', Title XXXVI of which is
the Methamphetamine Anti-Proliferation Act of 2000 (MAPA). One of the
consequences of MAPA was to redesignate 21 U.S.C. 830(b)(3)(A)(i) as 21
U.S.C. 830(b)(3)(B)(i). Further, MAPA required mail order reporting
requirements for export transactions involving ephedrine,
pseudoephedrine, or phenylpropanolamine. These reporting requirements
would not apply to distributions of drug products, including GHB,
pursuant to a valid prescription, which were excluded under MAPA (21
U.S.C. 830(b)(3)(D)). Regulations implementing the Methamphetamine
Anti-Proliferation Act of 2000 were published October 7, 2003 (68 FR
57799). Thus, the net effect is that all export transactions involving
GHB be reported to DEA. Transactions involving prescriptions of GHB are
not required to be reported to DEA.
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Assistant Administrator hereby certifies that this
rulemaking has been drafted in accordance with the Regulatory
Flexibility Act (5 U.S.C. 605(b)), 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[reg] (the FDA-approved product containing GHB) approval, a
risk management program was designed to limit its distribution. Under
this program, Xyrem[reg] will only be available to physicians and
patients through a single centralized pharmacy. As a result of this
program, at this time, controlled substances distributors and retail
pharmacies will not be handling Xyrem[reg] and, thus, will not be
affected by these requirements. For those few persons affected by these
proposed 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 proposed 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
$100 million or more in any one year, and would 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 practitioners under
proposed 21 CFR 1304.26, including the 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 practitioner. The
reporting requirements proposed under 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 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.
For the reasons set out above, 21 CFR Parts 1304, 1306 and 1310 are
proposed to be amended as follows:
[[Page 66051]]
PART 1304--RECORDS AND REPORTS OF REGISTRANTS [AMENDED]
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.
2. Section 1304.22 is proposed to be 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 pursuant to a prescription must also comply with
Sec. 1304.26.
* * * * *
3. Section 1304.26 is proposed to be added to read as follows:
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 records 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.
4. Section 1304.33 is proposed to be 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 [AMENDED]
1. The authority citation for Part 1306 continues to read as
follows:
Authority: 21 U.S.C. 821, 829, 871(b).
2. Section 1306.05 is proposed to be 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 [AMENDED]
1. The authority citation for part 1310 is revised to read as
follows:
Authority: 21 U.S.C. 802, 827(h), 830, 871(b).
2. Section 1310.03 is proposed to be 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, or 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.
[[Page 66052]]
Dated: November 14, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-29336 Filed 11-24-03; 8:45 am]
BILLING CODE 4410-09-P