[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 
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[Reserved].......................  ...............  ............  ......
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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