[Federal Register Volume 60, Number 210 (Tuesday, October 31, 1995)]
[Proposed Rules]
[Pages 55348-55353]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26890]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1309, 1310, and 1313
[DEA-138P]
RIN 1117-AA32
Removal of Exemption for Certain Pseudoephedrine Products
Marketed Under the Food, Drug, and Cosmetic Act (FD&C Act)
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Proposed rule.
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SUMMARY: This proposed rule is issued by the Deputy Administrator of
the Drug Enforcement Administration (DEA) to remove the exemption for
certain products containing pseudoephedrine (which are lawfully
marketed under the Federal Food, Drug, and Cosmetic Act) from the
chemical control provisions of the Controlled Substances Act (CSA) and
the Controlled Substances Import and Export Act. Due to the large scale
utilization of over-the-counter (OTC) pseudoephedrine products for the
clandestine manufacture of controlled substances, the DEA has
determined that certain products should be subject to recordkeeping,
reporting, registration and notification requirements of the CSA to
prevent their diversion. Such products include OTC tablets, capsules
and powder packets containing pseudoephedrine alone or in combination
with antihistamines, quaifenesin or dextromethorphan. This action also
proposes that the threshold for pseudoephedrine be reduced to 24.0
grams pseudoephedrine base. Such a threshold is sufficient to permit
the purchase of up to a 120 day supply of pseudoephedrine without the
application of regulatory requirements.
To further ensure the availability of pseudoephedrine products to
legitimate consumers at the retail level, this action also proposes to
waive the registration requirement for retail distributors of regulated
pseudoephedrine products.
DATES: Written comments and objections must be received by January 2,
1996.
FOR FURTHER INFORMATION CONTACT:
Howard McClain Jr., Chief, Drug and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement Administration, Washington, D.C.
20537. Telephone (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Background
The Chemical Diversion and Trafficking Act (PL 100-690) (CDTA)
[[Page 55349]]
amended the Controlled Substances Act and the Controlled Substances
Import and Export Act, and was passed by Congress to control the
diversion of certain chemicals (herein referred to as listed chemicals)
that are necessary for the illicit production of controlled substances.
The CDTA and its implementing regulations as set forth in Title 21,
Code of Federal Regulations (21 CFR), parts 1310 and 1313, established
a system of recordkeeping and reporting requirements through which DEA
and the chemical industry could identify persons seeking to divert
listed chemicals for the manufacture of illicit drugs. While bulk
ephedrine and pseudoephedrine were regulated under the CDTA, ephedrine
and pseudoephedrine products which are lawfully marketed or distributed
under the Federal Food, Drug, and Cosmetic Act (FD&C Act), were
originally exempt from CDTA regulations.
Since 1989, ephedrine has been the primary precursor used in the
clandestine synthesis of methamphetamine in the United States.
Clandestine laboratory operators have exploited the lack of controls on
OTC ephedrine products (such as tablets/capsules) to purchase millions
of dosage units for the synthesis of methamphetamine and methcathinone.
The Domestic Chemical Diversion Control Act (DCDCA) of 1993 (Public
Law 103-200) became effective on April 16, 1994. This Act further
amended the Controlled Substances Act and the Controlled Substances
Import and Export Act and removed the exemption for those transactions
involving products which are marketed or distributed lawfully in the
U.S. under the Federal Food, Drug, and Cosmetic Act, if these products
contain ephedrine (or its salts, optical isomers, or salts of optical
isomers) as the only active medicinal ingredient or contain ephedrine
in combination with therapeutically insignificant quantities of another
active medicinal ingredient. Thus single entity ephedrine products
became subject to reporting, recordkeeping and notification
requirements of the CSA. The DCDCA, however, did not remove the
exemption provided for pseudoephedrine OTC products, since the known
illicit use of pseudoephedrine was relatively infrequent when the DCDCA
was enacted.
The DCDCA also provided the Attorney General with the authority to
remove the exemption for any drug product containing a listed chemical
upon a determination that the drug product is being diverted for use in
the illicit production of a controlled substance. In addition, the
DCDCA imposed registration requirements for List I chemical handlers.
The CDTA established a system of thresholds for each listed
chemical to determine which transactions would be subject to regulatory
controls. Reporting, recordkeeping and notification requirements apply
to all regulated transactions which meet or exceed these threshold
amounts of a listed chemical. The threshold for ephedrine was
originally established as 1.0 kilogram for domestic, import and export
transactions. The threshold of 1.0 kilogram of ephedrine base is
equivalent to greater than 48,800 ephedrine 25 mg dosage units. Even
though the dosage form exemption was eliminated by the DCDCA, a 1.0
kilogram threshold was not adequate to prevent the significant
diversion of ephedrine to clandestine laboratories in the United
States.
Given evidence of the large-scale diversion of ephedrine from
various types of outlets and the public health threat imposed by the
diversion of these products, the DEA determined that additional action
was needed to prevent further diversion. Effective November 10, 1994
(59 FR 51365) the DEA eliminated the threshold for ephedrine.
Subsequently, all regulated transactions of ephedrine became subject to
reporting, recordkeeping and notification requirements of the CSA
regardless of size.
In response to regulatory and other actions taken against single-
entity ephedrine products, clandestine laboratory operators have again
attempted to circumvent CSA chemical controls in an effort to obtain
precursor material. The search for unregulated sources of precursor
material has led to the diversion and illicit utilization of OTC
ephedrine combination products and OTC pseudoephedrine products. The
DEA is currently reviewing the regulatory options which address the
diversion of OTC ephedrine combination products. This issue will be
addressed in the near future.
Pseudoephedrine and ephedrine are related as diastereomers. Because
of this structural relationship, pseudoephedrine can serve as a direct
substitute for ephedrine in the synthesis of methamphetamine.
Clandestine laboratory operators are exploiting the lack of regulatory
controls on OTC pseudoephedrine products by obtaining pseudoephedrine
for use as precursor material for the synthesis of methamphetamine.
Due to the significant increase in the utilization of
pseudoephedrine products for the illicit manufacture of these
controlled substances, the DEA Deputy Administrator has determined that
some of these products should be subject to recordkeeping, reporting,
registration and notification requirements of the Controlled Substances
Act and the Controlled Substances Import and Export Act, in order to
prevent their diversion. This action proposes to remove the exemption
for certain OTC products containing pseudoephedrine. These
pseudoephedrine products shall therefore be subject to regulatory
provisions of the CSA.
Removal of Exemption
21 U.S.C. 814(a) provides that the Attorney General may remove from
exemption under 21 U.S.C. 802(39)(A)(iv) any drug or group of drugs
that the Attorney General finds is being diverted to obtain a listed
chemical for use in the illicit production of a controlled substance.
21 U.S.C. 814(b) further provides that in removing the exemption for a
drug or group of drugs, the Attorney General shall consider (1) the
scope, duration, and significance of the diversion, (2) whether the
drug or group of drugs is formulated in such a way that it cannot be
easily used in the illicit production of a controlled substance and (3)
whether the listed chemical can be readily recovered from the drug or
group of drugs. A summary analysis of these factors follows.
Methamphetamine is the most prevalent controlled substance
clandestinely synthesized in the United States. Between January 1, 1994
and September 15, 1995 the DEA has been involved in the domestic
seizure of 453 methamphetamine laboratories. Ephedrine and/or
pseudoephedrine were utilized as the precursor material at
approximately 85 percent of these laboratories.
Evidence of the illicit utilization of pseudoephedrine in
clandestine laboratories is increasing. The identification of OTC
pseudoephedrine products at clandestine methamphetamine laboratories
increased dramatically in 1995. Pseudoephedrine was utilized in at
least 11 percent of the laboratories seized in 1994 and 22 percent in
1995. The DEA and local law enforcement have intercepted and seized
millions of pseudoephedrine dosage units from mail order shipments
destined for individuals for subsequent use in the illicit manufacture
of methamphetamine.
Pseudoephedrine is available in a variety of dosage forms either as
single entity products or in combination with one or more other active
medicinal ingredients. While the majority of OTC
[[Page 55350]]
pseudoephedrine products currently used for the illicit production of
methamphetamine are single entity products, some combination products
have been identified at clandestine laboratories. The DEA has reviewed
the various pseudoephedrine dosage forms and available combinations of
ingredients. Some of these products are formulated in such a way that
the product itself can be used in the illicit production of
methamphetamine; others are formulated in such a way that
pseudoephedrine can be readily recovered from the product; and some of
these products are formulated in such a way that the manufacture of
methamphetamine is impeded. Based on this analysis, the DEA has
determined that OTC solid dosage form products (i.e. tablets, capsules
and powder packets) lawfully marketed under the Federal Food, Drug, and
Cosmetic Act and which contain pseudoephedrine in combination with
acetaminophen, aspirin or ibuprofen are formulated in such a way that
pseudoephedrine cannot be readily recovered and these products are not
easily used as precursors for the illicit production of
methamphetamine. In addition, the DEA has determined that OTC liquids,
syrups and soft gelatin capsules, which are lawfully marketed under the
Food, Drug, and Cosmetic Act and which contain pseudoephedrine either
as the sole active ingredient or in combination with other active
ingredients, are formulated in such a way that the pseudoephedrine
cannot be readily recovered and the products cannot be easily used in
the illicit production of methamphetamine.
Thus the DEA is proposing to remove the exemption under 21 CFR
1310.01(f)(1)(iv) for OTC solid dosage form pseudoephedrine products
(i.e. tablets, capsules and powder packets) lawfully marketed under the
Food, Drug, and Cosmetic Act, which do not contain therapeutically
significant quantities of acetaminophen, aspirin or ibuprofen. These
products, which include tablets, capsules and powder packets containing
pseudoephedrine as the sole active ingredient or in combination with
one or more active indgredients such as antihistamines, guaifenesin or
dextromethorphan, will be subject to the regulatory requirements of the
CSA.
For purposes of this paragraph, the term ``therapeutically
significant quantities'' shall apply if the product formulation (i.e.
the qualitative and quantitative composition of active ingredients
within the product) is listed in current editions of the American
Pharmaceutical Association (APhA) Handbook of NonPrescription Drugs;
Drug Facts and Comparisons (published by Wolters Kluwer Company); or
USP DI (published by the authority of the United States Pharmacopeial
Convention, Inc.). For drug products having a formulation not found in
the above compendiums, the DEA Administrator shall determine, pursuant
to a written request as specified in Section 1310.14, whether the
active medicinal ingredients are present in quantities considered
therapeutically significant for purposes of this paragraph.
The exemption provided under 21 CFR 1310.01(f)(1)(iv) will remain
for liquids, syrups, and soft gelatin capsules containing
pseudoephedrine and any type of solid dosage form product which
contains pseudoephedrine in combination with therapeutically
significant quantities of either acetaminophen, aspirin or ibuprofen
provided that the product is lawfully marketed under the Food, Drug,
and Cosmetic Act. In addition, the proposed regulations allow
pseudoephedrine prescription products, regardless of the product
formulation, to remain exempt from the proposed regulations, given
existing distribution and dispensing requirements already imposed under
the Federal Food, Drug and Cosmetic Act.
Pursuant to 21 U.S.C. 814(c), the DEA has considered the evidence
of diversion of the above listed pseudoephedrine products, the pattern
of diversion of ephedrine products, including combination products and
other relevant data, and has determined that the affected group of
pseudoephedrine products is limited to that necessary to prevent the
diversion of pseudoephedrine products to illicit methamphetamine
laboratories.
Revision of Threshold
The current threshold for pseudoephedrine is 1.0 kilogram for
domestic, import and export transactions. Even if the exemption for
certain OTC pseudoephedrine products is eliminated, a 1.0 kilogram
threshold is not adequate to prevent the significant diversion of these
pseudoephedrine products to clandestine laboratories. The threshold of
1.0 kilogram of pseudoephedrine base is equivalent to greater than
20,000 pseudoephedrine HCl 60 mg dosage units. Therefore, the DEA
proposes to reduce the threshold for pseudoephedrine. In order to
ensure that OTC pseudoephedrine products remain available to those
individuals who utilize these decongestants for legitimate medical
purposes, the DEA proposes to establish the threshold for
pseudoephedrine at a level consistent with personal use. As such,
individuals who purchase below-threshold quantities intended for
legitimate personal medical use, and retailers who sell below-threshold
quantities for use by individuals for legitimate personal medical use,
will not be adversely impacted by these regulations.
The Food and Drug Administration (FDA) has established a labeling
requirement which sets the maximum adult daily dosage of
pseudoephedrine at 60 mg every 6 hours or 240 mg per day. A 120 day
supply of pseudoephedrine at the maximum daily recommended dose of 240
mg pseudoephedrine hydrochloride per day is equivalent to 28.8 gm of
pseudoephedrine hydrochloride or 23.7 gm pseudoephedrine base.
Therefore, the DEA proposes to establish a threshold of 24.0 grams
pseudoephedrine base. Such a threshold will allow the purchase and sale
of up to 120 day supply of pseudoephedrine for personal legitimate
medical use, without the application of regulatory requirements. This
will allow continued access to these products for legitimate use.
Waiver of Registration
In an effort to ensure the continued availability of
pseudoephedrine products for legitimate personal use at the retail
level, the DEA also proposes a waiver from registration for any retail
distributor of regulated pseudoephedrine products. The authority for
providing a waiver is clearly set forth in 21 U.S.C. Section 822(d)
whereby ``The Attorney General 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.''
Therefore retail distributors (defined under 21 CFR 1309.02 as
selling only personal use quantities to walk-in customers) of regulated
pseudoephedrine products would not be required to obtain a DEA
registration for such transactions.
As discussed later, it is estimated that there are approximately
750,000 retail distributors of pseudoephedrine in the U.S. Such a
waiver would benefit the vast majority of these distributors. Firms
engaging in above-threshold transactions of non-exempt pseudoephedrine
products, however, would not be retail distributors. Therefore they
would be required to obtain a DEA registration as a distributor,
maintain records as specified in 21 CFR 1310.04 and report suspicious
transactions as specified in
[[Page 55351]]
21 CFR 1310.05 notification requirement. In addition, all importers,
exporters and other types of distributors of non-exempt pseudoephedrine
products would be required to register with the DEA and would be
subject to the full regulatory provisions of the Controlled Substances
Act and the Controlled Substances Import and Export Act.
The clandestine manufacture and abuse of methamphetamine are
serious national public health problems which require Federal action.
Companies operating on the fringe of legitimate commerce are supplying
these clandestine laboratories. In an effort to minimize the impact of
the proposed regulations on the legitimate industry, the DEA has
examined various options available.
The DEA is aware of the large scale legitimate use of OTC
pseudoephedrine products and their widespread distribution at retail
outlets. However, the DEA believes that the registration,
recordkeeping, reporting and notification requirements that have been
successfully used to limit the diversion of other chemicals to
clandestine laboratories are needed to control this problem.
The DEA has determined that approximately 750,000 retail
distributors and an undetermined number of other distributors would be
impacted if pseudoephedrine products were made subject to the full
extent of the CSA chemical regulatory provisions. However, in
recognizing the need to limit the regulatory burden on handlers of
pseudoephedrine products to the minimum level necessary to prevent the
large scale diversion of these products for clandestine use, the DEA
has taken significant steps to minimize the burden on the 750,000
retailers who sell these pseudoephedrine products.
First, given the large number of retail distributors who handle
these products in the United States, the DEA has proposed that relief
be provided by providing a waiver from registration for these
distributors. Thus, the proposed regulations primarily impact
distributors who are not classified as retail distributors. These
distributors include mail-order and wholesale distributors. The DEA has
attempted to identify the number of firms which will be impacted by
these regulations. This review included consultation with industry
associations and other Federal and local government agencies. These
entities were only able to identify a limited number of newly affected
firms.
Secondly, the DEA has limited controls to a specific group of
products which have been demonstrated to be most readily used for
illicit purposes. The DEA believes that this approach provides
effective protection against diversion while minimizing the burden on
industry. Thirdly, the proposed regulations allow for the purchase and
sale of up to a 120 day supply of pseudoephedrine for personal
legitimate medical use, without the application of regulatory
requirements.
The DEA has consulted with the National Wholesale Druggists
Association (NWDA) in an effort to determine the potential size of the
impacted industry. According to NWDA sources, there are approximately
750,000 retail distributors in the U.S. which sell over-the-counter
pseudoephedrine products.
In addition, the DEA has met with the Nonprescription Drug
Manufacturers Association (NDMA) regarding the U.S. pseudoephedrine
market and to obtain input on the distribution of pseudoephedrine for
legitimate medical use. NDMA has further confirmed that there are
approximately 750,000 retail distributors of over-the-counter products
in the U.S. NDMA, which stated that its members account for the
manufacture of over 90 percent of the over-the-counter drugs marketed
domestically, informed DEA that member companies primarily distribute
pseudoephedrine in package sizes ranging from 10 to 60 solid dosage
units per package. In an effort to reduce the adverse impact upon those
who sell and purchase pseudoephedrine products at the retail level, the
DEA ensured that the proposed threshold was well above the standard
package size manufactured by NDMA members and distributed by retail
distributors. The proposed threshold of 24.0 grams pssudoephedrine base
is equivalent to 488 pseudoephedrine hydrochloride 60 mg dosage units.
The primary impact of the proposed regulations will be upon those
entities not classified as retail distributors. Such entities include
mail-order distributors and wholesale distributors. The DEA has
attempted to quantify the number of these distributors in the U.S. The
NWDA informed the DEA that its 1993 Operating Survey indicated that 70
full-line drug wholesalers (who distribute both prescription and over-
the-counter products) distributed nearly 80 percent of the prescription
drugs in the U.S. in 1993. These full-line drug wholesalers operated
approximately 230 distribution centers. Current information provided by
NWDA indicates that due to consolidation within the drug wholesale
industry, there are currently only approximately 50 full-line wholesale
distributors supplying this market in the U.S.
These firms are already CSA registrants and as such would not need
to obtain a separate registration under the proposed regulations (21
CFR 1309.25). In addition, the impact upon these full-line distributors
will be minimized since, pursuant to 1310.06(b), normal business
records shall be considered adequate if they contain the information
required in 21 CFR 1310.06(a) and are readily retrievable from other
business records.
The NWDA was unable to provide estimates of the percentage of the
over-the-counter market supplied by these full-line distributors but
informed DEA of the existence of other smaller wholesale distributors
who only distribute over-the-counter pseudoephedrine products. These
wholesale distributors will be impacted by the proposed regulations
since they will be required to register with the DEA and ensure that
records maintained are adequate to meet the requirements under Section
1310.06.
In addition to contact with the industry associations, the DEA has
contacted the National Association of Boards of Pharmacy and individual
State Boards of Pharmacy in an attempt to quantify the number of these
distributors currently operating in the U.S. which will be impacted by
these regulations. The DEA has not been successful in quantifying the
number of these firms operating in the U.S. or in finding a
professional association which represents these business entities.
However, the State of Idaho licenses all business entities which
distribute over-the-counter products into or within the state. The
Idaho Board of Pharmacy indicated that the majority of the distributors
are actually outside of Idaho and that only 418 distributors are
licensed to distribute drug products into Idaho.
The DEA has attempted to limit the regulatory burden on
pseudoephedrine handlers. The proposed regulations include provisions
which ensure that the 750,000 retailers of pseudoephedrine will not be
adversely impacted. These 750,000 retail distributors will not be
required to register or maintain records unless they engage in
transactions of a limited group of pseudoephedrine products in
quantities which exceed a 120 day supply. Therefore the vast majority
of retail distributors will not be impacted by these regulations.
While other types of distributors will be subject to the proposed
regulatory controls, the DEA ( in consultation with industry
associations and other
[[Page 55352]]
government agencies) has been able to identify only a limited number of
these newly affected firms. The DEA welcomes any information regarding
the number of entities affected.
The Attorney General has delegated authority under the CSA and all
subsequent amendments to the CSA to the Administrator of the DEA (28
CFR 0.100). The Administrator, in turn, has redelegated this authority
to the Deputy Administrator pursuant to 28 CFR 0.104.
The Deputy Administrator 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.
This proposed rule has been reviewed pursuant to the principles of
Executive Order 12866. It has been determined that the proposed rule is
not significant regulatory action and therefore has not been reviewed
by the Office of Management and Budget pursuant to Executive Order
12866.
This proposed action has been analyzed in accordance with the
principles and criteria in E.O. 12612, and it has been determined that
the proposed rule does not have sufficient federalism implications to
warrant the preparation of a Federalism Assessment.
List of Subjects
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control,
Security measures, List I and List II chemicals.
21 CFR Part 1310
Drug traffic control, Reporting and recordkeeping requirements,
List I and List II chemicals.
21 CFR Part 1313
Drug traffic control, Imports, Exports, Transshipment and in-
transit shipments, List I and List II chemicals.
For reasons as set out above, 21 CFR Parts 1309, 1310 and 1313 are
proposed to be amended as follows:
PART 1309--[AMENDED]
1. The authority citation for Part 1309 continues to read as
follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877,
958.
2. Section 1309 is proposed to be amended by adding a new paragraph
1309.28 to read as follows:
Sec. 1309.28 Exemption of retail distributors of certain
pseudoephedrine products.
The requirement of registration is waived for any retail
distributor, for the distribution of any product containing
pseudoephedrine that is regulated pursuant to Section
1310.01(f)(1)(iv)(A)(2). The term retail distributor, as defined in
Section 1309.02(g), means a distributor whose List I chemical
activities are restricted to the sale of drug products that are
regulated as List I chemicals pursuant to Section 1310.01(f)(1)(iv),
directly to walk-in customers for personal use. For purposes of this
paragraph, sale for personal use means the sale of below-threshold
quantities in a single transaction to an individual for legitimate
medical use. (The threshold of 24.0 grams pseudoephedrine base is
equivalent to 488 pseudoephedrine hydrochloride 60 mg dosage units.)
3. Section 1309.71 is proposed to be amended by revising paragraph
(a)(2) to read as follows:
Sec. 1309.71 General security requirements.
* * * * *
(a) * * *
(2) In retail settings open to the public where drugs containing
List I chemicals that are regulated pursuant to Section
1310.01(f)(1)(iv)(A)(1) are distributed, such drugs will be stocked
behind a counter where only employees have access.
* * * * *
PART 1310--[AMENDED]
1. The authority citation for Part 1310 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b).
2. Section 1310.01 is proposed to be amended by revising paragraph
(f)(1)(iv)(A) to read as follows:
Sec. 1310.01 Definitions.
* * * * *
(f) * * *
(1) * * *
(iv) * * *
(A)(1) The drug contains ephedrine or its salts, optical isomers,
or salts of optical isomers as the only active medicinal ingredient or
contains ephedrine or its salts, optical isomers, or salts of optical
isomers and therapeutically insignificant quantities of another active
medicinal ingredient. For purposes of this paragraph, the term
``therapeutically insignificant quantities'' shall apply if the product
formulation (i.e., the qualitative and quantitative composition of
active ingredients within the product) is not listed in current
editions of the American Pharmaceutical Association (APhA) Handbook of
NonPrescription Drugs; Drug Facts and Comparisons (published by Wolters
Kluwer Company); or USP DI (published by the authority of the United
States Pharmacopeial Convention, Inc.); or the product is not listed in
Section 1310.15 as an exempt drug product. For drug products having
formulations not found in the above compendiums, the Administrator
shall determine, pursuant to a written request as specified in Section
1310.14, whether the active medicinal ingredients are present in
quantities considered therapeutically significant for purposes of this
paragraph; or
(2) The drug is an over-the-counter (OTC) solid dosage form product
(tablet, capsule or powder packet) which contains pseudoephedrine or
its salts, optical isomers, or salts of optical isomers but does not
contain either acetaminophen, aspirin or ibuprofen in therapeutically
significant quantities. For purposes of this paragraph, the quantities
of either acetaminophen, aspirin or ibuprofen present in a
pseudoephedrine drug product shall be considered to be present in
``therapeutically significant quantities'' if the product formulation
(i.e. the qualitative and quantitative composition of active
ingredients within the product) is listed in current editions of the
American Pharmacoutical Association (APhA) Handbook of NonPrescription
Drugs; Drug Facts and Comparisons (published by Wolters Kluwer
Company); or USP DI (published by the authority of the United States
Pharmacopeial Convention, Inc.); or the product is listed in Section
1310.15 as an exempt drug product. For drug products having a
formulation not found in the above compendiums, the Administrator shall
determine, pursuant to a written request as specified in Section
1310.14, whether the active medicinal ingredients (acetaminophen,
aspirin or ibuprofen) are present in quantities considered
therapeutically significant for purposes of this paragraph; or
* * * * *
3. Section 1310.04 is proposed to be amended by revising paragraph
(f)(1)(x) to read as follows:
Sec. 1310.04 Maintenance of records.
* * * * *
(f) * * *
(1) List I Chemicals:
------------------------------------------------------------------------
Chemical Threshold by base weight
------------------------------------------------------------------------
(x) Pseudoephedrine, its salts, optical 24 grams.
isomers and salts of optical isomers.
------------------------------------------------------------------------
* * * * *
[[Page 55353]]
4. Section 1310.14 is proposed to be amended by revising the
heading and by revising paragraph (a) to read as follows:
Sec. 1310.14 Exemption of certain ephedrine or pseudoephedrine
combination drug products.
(a) Any manufacturer of a drug product containing ephedrine in
combination with another active medicinal ingredient, the product
formulation of which is not listed in the compendiums set forth in
Section 1310.01(f)(1)(iv)(A)(1), or any manufacturer of a drug product
containing pseudoephedrine in combination with acetaminophen, aspirin
or ibuprofen, the product formulation of which is not listed in the
compendiums set forth in Section 1310.01(f)(1)(iv)(A)(2), may request
that the Administrator exempt the product as one which contains
ephedrine together with therapeutically significant quantities of the
other active medicinal ingredients or pseudoephedrine in combination
with therapeutically significant quantities of acetaminophen, aspirin
or ibuprofen.
* * * * *
5. Section 1310.15 is proposed to be amended by revising the
heading, by revising paragraph (a), and by revising paragraph (d) to
read as follows:
Sec. 1310.15 Exempt combination drug products containing ephedrine or
pseudoephedrine.
(a) The drug products containing ephedrine in combination with
therapeutically significant quantities of another active medicinal
ingredient, or pseudoephedrine in combination with therapeutically
significant quantities of acetaminophen, aspirin, or ibuprofen; listed
in paragraph (e) of this section, have been exempted by the
Administrator from application of sections 302, 303, 310, 1007, and
1008 of the Act (21 U.S.C. 822-3, 830, and 957-8) to the extent
described in paragraphs (b), (c), and (d) of this section.
* * * * *
(d) In addition to the drug products listed in the compendium set
forth in Section 1310.01(f)(1)(iv)(A)(1) and 1310.01(f)(1)(iv)(A)(2),
the following drug products, in the form and quantity listed in the
application submitted (indicated as the ``date'') are designated as
exempt drug products for the purposes set forth in this section:
Exempt Drug Products Containing Ephedrine in Combination With
Therapeutically Significant Quantities of Another Active Medicinal
Ingredient and Exempt Drug Products Containing Pseudoephedrine in
Combination With Therapeutically Significant Quantities of
Acetaminophen, Aspirin or Ibuprofen
------------------------------------------------------------------------
Supplier Product name Form Date
------------------------------------------------------------------------
[Reserved]....................... ............... ............ ......
------------------------------------------------------------------------
PART 1313--[AMENDED]
1. The authority citation for Part 1313 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
2. Section 1313.02 is proposed to be amended by revising paragraph
(d)(1)(iv)(A) to read as follows:
Sec. 1313.02 Definitions.
* * * * *
(d) * * *
(1) * * *
(iv) * * *
(A)(1) The drug contains ephedrine or its salts, optical isomers,
or salts of optical isomers as the only active medicinal ingredient or
contains ephedrine or its salts, optical isomers, or salts of optical
isomers and therapeutically insignificant quantities of another active
medicinal ingredient. For purposes of this paragraph, the term
``therapeutically insignificant quantities'' shall apply if the product
formulation (i.e. the qualitative and quantitative composition of
active ingredients within the product) is not listed in current
editions of the American Pharmaceutical Association (APhA) Handbook of
NonPrescription Drugs; Drug Facts and Comparisons (published by Wolters
Kluwer Company); or USP DI (published by the authority of the United
States Pharmacopeial Convention, Inc.); or the product is not listed in
Section 1310.15 as an exempt drug product. For drug products having
formulations not found in the above compendiums, the Administrator
shall determine, pursuant to a written request as specified in Section
1310.14, whether the active medicinal ingredients are present in
quantities considered therapeutically significant for purposes of this
paragraph; or
(2) The drug is an over-the-counter (OTC) solid dosage form product
(tablet, capsule or powder packet) which contains pseudoephedrine or
its salts, optical isomers, or salts of optical isomers, but does not
contain either acetaminophen, aspirin or ibuprofen in therapeutically
significant quantities. For purposes of this paragraph, the quantities
of either acetaminophen, aspirin or ibuprofen present in a
pseudoephedrine drug product shall be considered to be present in
``therapeutically significant quantities'' if the product formulation
(i.e. the qualitative and quantitative composition of the active
ingredients within the product) is listed in current editions of the
American Pharmaceutical Association (APhA) Handbook of NonPrescription
Drugs; Drug Facts and Comparisons (published by Wolters Kluwer
Company); or USP DI (published by the authority of the United States
Pharmacopeial Convention, Inc.); or the product is listed in Section
1310.15 as an exempt drug product. For drug products having a
formulation not found in the above compendiums, the Administrator shall
determine, pursuant to a written request as specified in Section
1310.14, whether the active medicinal ingredients (acetaminophen,
aspirin or ibuprofen) are present in quantities considered
therapeutically significant for purposes of this paragraph; or
* * * * *
Dated: October 25, 1995.
Stephen H. Greene,
Deputy Administrator.
[FR Doc. 95-26890 Filed 10-30-95; 8:45 am]
BILLING CODE 4410-09-M
