[Federal Register Volume 68, Number 194 (Tuesday, October 7, 2003)]
[Rules and Regulations]
[Pages 57799-57804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-25100]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1309, and 1310

[Docket No. DEA-210F]
RIN 1117-AA69


Implementation of the Methamphetamine Anti-Proliferation Act; 
Thresholds for Retailers and for Distributors Required To Submit Mail 
Order Reports; Changes to Mail Order Reporting Requirements

AGENCY: Drug Enforcement Administration (DEA), Justice.

ACTION: Final rule.

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[[Page 57800]]

SUMMARY: This regulation implements the new threshold requirements and 
mail order reporting requirements of the Methamphetamine Anti-
Proliferation Act of 2000 (MAPA), which was enacted on October 17, 
2000. DEA is amending its regulations to reduce the thresholds for 
pseudoephedrine and phenylpropanolamine for retail distributors and for 
distributors required to submit mail order reports. Also, DEA is 
amending its regulations to require mail order reports for certain 
export transactions. DEA is codifying exemptions from the mail order 
reporting requirements for certain distributions to nonregulated 
persons and certain export transactions. This rule is consistent with 
the intent of MAPA to prevent the diversion of drug products to the 
clandestine manufacture of methamphetamine and amphetamine, and 
simultaneously reduce the industry reporting burden.

EFFECTIVE DATE: November 6, 2003.

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 DEA's Legal Authority for This Rule?

    DEA implements the Controlled Substances Act (21 U.S.C. 801-971), 
as amended by the Chemical Diversion and Trafficking Act, the Domestic 
Chemical Diversion Control Act, the Comprehensive Methamphetamine 
Control Act, and the recent Methamphetamine Anti-Proliferation Act 
(Pub. L. 106-310, 114 Stat. 1101), among others. DEA publishes the 
implementing regulations for these statutes in title 21 of the Code of 
Federal Regulations (21 CFR) parts 1300 to end. The regulations are 
designed to prevent the diversion of controlled substances and listed 
chemicals to illegal purposes.
    MAPA, which is part of the Children's Health Act of 2000, amends 
the Controlled Substances Act (CSA) to reduce the retail and mail order 
thresholds for pseudoephedrine and phenylpropanolamine (PPA), to 
include certain export transactions under the mail order reporting 
requirement, and to provide certain exemptions from the mail order 
reporting requirement. This rule implements the Congressional mandate 
of MAPA.

Why Is DEA Publishing a Final Rule?

    An agency may find good cause to exempt a rule from the provisions 
of the Administrative Procedure Act (5 U.S.C. 553), including notice of 
proposed rulemaking and the opportunity for public comment, if it is 
determined to be unnecessary, impracticable, or contrary to the public 
interest. Most of the requirements of MAPA were set out in such detail 
as to be self-implementing. Therefore the changes in this rulemaking 
primarily provide conforming amendments to make the language of the 
regulations consistent with that of the law. Hence, DEA finds it 
unnecessary to publish for public notice and comment.
    Specifically, Title XXXVI, Methamphetamine Anti-Proliferation Act, 
Section 3652 of the Children's Health Act, ``Mail Order Requirements,'' 
amends 21 U.S.C. 830(b)(3)(D) to exempt certain distributions and 
export transactions of ephedrine, pseudoephedrine, and 
phenylpropanolamine and drug products containing them from the monthly 
mail order reporting requirement as follows [emphasis added]:

    (D) Except as provided in subparagraph (E), the following 
distributions to a nonregulated person, and the following export 
transactions, shall not be subject to the reporting requirement in 
subparagraph (B):
    (i) Distributions of sample packages of drug products when such 
packages contain not more than 2 solid dosage units or the 
equivalent of 2 dosage units in liquid form, not to exceed 10 
milliliters of liquid per package, and not more than one package is 
distributed to an individual or residential address in any 30-day 
period.
    (ii) Distributions of drug products by retail distributors that 
may not include face-to-face transactions to the extent that such 
distributions are consistent with the activities authorized for a 
retail distributor as specified in section 102(46). [21 U.S.C. 
802(46)]
    (iii) Distributions of drug products to a resident of a long 
term care facility (as the term is defined in regulations prescribed 
by the Attorney General) or distributions of drug products to a long 
term care facility for dispensing to or for use by a resident of 
that facility.
    (iv) Distributions of drug products pursuant to a valid 
prescription.
    (v) Exports which have been reported to the Attorney General 
pursuant to section 1004 [21 U.S.C. 954] or 1018 [21 U.S.C. 971] 
which are subject to a waiver granted under section 1018(e)(2) [21 
U.S.C. 971(e)(2)].
    (vi) Any quantity, method, or type of distribution or any 
quantity, method, or type of distribution of a specific listed 
chemical (including specific formulations or drug products) or of a 
group of listed chemicals (including specific formulations or drug 
products) which the Attorney General has excluded by regulation from 
such reporting requirement on the basis that such reporting is not 
necessary for the enforcement of this title * * *

    Editor's Note: This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 830(b)(3)(D).

    MAPA also specifically reduces the threshold for drug products 
containing pseudoephedrine and phenylpropanolamine from 24 grams to 9 
grams of pseudoephedrine or phenylpropanolamine as base. MAPA further 
establishes a new factor in determining a regulated transaction--a 
package size of 3 grams of pseudoephedrine base or phenylpropanolamine 
base. The language in Title XXXVI, Section 3622 of the Children's 
Health Act of 2000, ``Reduction in Retail Sales Transaction Threshold 
for Non-Safe Harbor Products Containing Pseudoephedrine or 
Phenylpropanolamine,'' clearly establishes without opportunity for 
discussion the new requirements. It amends 21 U.S.C. 802(39)(a)(iv)(II) 
to read as follows [emphasis added]:

    (II) the quantity of ephedrine, pseudoephedrine, 
phenylpropanolamine, or other listed chemical contained in the drug 
included in the transaction or multiple transactions equals or 
exceeds the threshold established for that chemical by the Attorney 
General, except that the threshold for any sale of products 
containing pseudoephedrine or phenylpropanolamine by retail 
distributors or by distributors required to submit reports by 
section 310(b)(3) of this title [21 U.S.C. 830(b)(3)] shall be 9 
grams of pseudoephedrine or 9 grams of phenylpropanolamine in a 
single transaction and sold in package sizes of not more than 3 
grams of pseudoephedrine base or 3 grams of phenylpropanolamine 
base; * * *

    Editor's Note: This excerpt of the amendment is published for 
the convenience of the reader. The official text is published at 21 
U.S.C. 802(39)(a)(iv)(II).

    Under the circumstances, there is no discretion for deviation from 
the changes made by MAPA. Therefore, DEA is implementing these 
conforming amendments to the regulations through a final rule.

Do the Thresholds Apply to All Retail Distributors and All Distributors 
Required To Submit Mail Order Reports?

    MAPA mandated that effective October 17, 2001, both the reduction 
of the 24 gram transaction threshold to 9 grams and the addition of the 
3 gram package size threshold for pseudoephedrine and 
phenylpropanolamine drug products apply to all retail distributors and 
all persons required to submit mail order reports under 21 U.S.C. 
830(b)(3).
    At the retail level, all drug products containing pseudoephedrine 
or phenylpropanolamine that do not meet

[[Page 57801]]

the definition of ``ordinary over-the-counter pseudoephedrine or 
phenylpropanolamine product'' (see 21 U.S.C. 802(45)) are subject to 
the threshold requirements of MAPA. This includes the single 
transaction threshold of 9 grams as base and the single package size of 
3 grams or less of pseudoephedrine or 3 grams or less of 
phenylpropanolamine as base. The requirement of registration is waived 
for retail distributors whose activities consist solely of below-
threshold distributions to an individual for a legitimate medical 
purpose (21 CFR 1309.24(e)). Retail distributors who engage in single 
transactions at or above 9 grams of pseudoephedrine or 
phenylpropanolamine as base or single transactions of package sizes 
containing more than 3 grams of pseudoephedrine base or 3 grams of 
phenylpropanolamine base per package will void their waiver of the 
registration requirement and must register with DEA. Transactions above 
these thresholds are regulated transactions and subject to all 
requirements of the Controlled Substances Act. For retail transactions, 
this would include customer identification, recordkeeping, and 
reporting.
    For those required to submit mail order reports, the 9 gram 
transaction threshold (as base) for a single transaction and the 3 gram 
package size (as base) apply to every transaction involving 
pseudoephedrine, phenylpropanolamine or drug products containing them--
regardless of the type of packaging for the products. There are no 
exemptions for ordinary over-the-counter pseudoephedrine and 
phenylpropanolamine products. All of the requirements of the CSA apply 
to threshold and above transactions and to above-threshold package 
sizes, that is, registration, identification, recordkeeping, and 
reporting, as well as the monthly mail order reports submitted to DEA.

What Are the Changes to the Mail Order Reporting Requirement?

    MAPA provides the following exemptions to the mail order reporting 
requirement: Transactions involving sample packages of drug products, 
deliveries of prescriptions to consumers by retail distributors, 
distributions to long-term care facilities and their residents, mail 
order prescription deliveries, and exports already reported to DEA on a 
Form 486 or granted a waiver by the Administrator. These were 
specifically cited in the section of this rulemaking titled, ``Why is 
DEA publishing a final rule?''
    Congress also granted the Attorney General the authority (delegated 
to the Administrator of DEA) to develop regulations to expand the 
Congressional list of exemptions.

What Action Is DEA Taking To Codify the MAPA Amendments in Its 
Regulations?

    To implement the requirements of MAPA, DEA is adding the new 
definitions of ``drug product'' and ``valid prescription'' at 21 CFR 
1300.02, and updating Sec. Sec.  1310.03 and 1310.05 to reflect the 
revised reporting requirements for mail order distributions. 
Specifically, DEA is amending Sec.  1310.05 to explicitly exempt from 
the reporting requirements the low-risk categories of mail order 
transactions previously listed.
    DEA also reserves the right to exempt, by regulation, from the 
reporting requirements any other quantity, method, or type of 
distribution of a specific listed chemical (or drug product containing 
it) or group of listed chemicals (or drug products containing them) 
determined by the Administrator to be unnecessary for the effective 
enforcement of the Controlled Substances Act.

What Is the Effect of MAPA on the Public and on Industry?

    MAPA will not adversely impact the public's access to 
pseudoephedrine and phenylpropanolamine products. The majority of the 
products purchased by the public are commonly used medications most of 
which are available without a prescription at pharmacies, grocery 
stores, discount department stores, and a variety of other retail 
stores. Although the thresholds are being reduced, these thresholds 
still permit the public adequate access to these drug products for 
legitimate medical purposes, which include their use as decongestants 
for the temporary relief of nasal congestion. Each of the products is 
available as a single entity or in combination with antihistamines, 
antitussives, analgesics, and expectorants. Sale of a single package of 
drug product containing 3 grams or less per package of pseudoephedrine 
or phenylpropanolamine base is not a regulated transaction. A single 
transaction of less than 9 grams of pseudoephedrine or 
phenylpropanolamine as base is not a regulated transaction. The chart 
below indicates the number of tablets per package and per single 
transaction that constitute a regulated transaction. One tablet less 
would be a non-regulated transaction.

  Number of Tablets That Constitute a Regulated Transaction for Dosage
                      Units of Marketed Products *
------------------------------------------------------------------------
                                             Number of       Number of
                                           tablets  over  tablets  per 9-
              Product type                    3-gram           gram
                                           package size     transaction
------------------------------------------------------------------------
                             Pseudoephedrine
------------------------------------------------------------------------
120-mg Hydrochloride....................              31              92
120-mg Sulfate..........................              33              98
60-mg Hydrochloride.....................              62             184
60-mg Sulfate...........................              65             195
30-mg Hydrochloride.....................             123             367
30-mg Sulfate...........................             130             390
-----------------------------------------
                           Phenylpropanolamine
------------------------------------------------------------------------
75-mg Hydrochloride.....................              50             149
25-mg Hydrochloride.....................             149             447
12.5-mg Hydrochloride...................             298             894
6.25-mg Hydrochloride...................             596           1,788
------------------------------------------------------------------------
* Calculated as base.


[[Page 57802]]

    For example, if a member of the public purchased product containing 
30-mg pseudoephedrine hydrochloride tablets in a single transaction of 
366 tablets, it would not be regulated. However, if that person 
purchased 367 or more tablets of the same product in a single 
transaction, it would be a regulated transaction. The member of the 
public would still be permitted to make such a purchase, but would be 
required to provide the distributor with certain information. DEA 
believes that few members of the public make such large purchases for 
legitimate personal medical use, and thus will not be adversely 
impacted by this rulemaking.
    Due to concerns regarding possible harmful side effects, the Food 
and Drug Administration initiated action in November 2000 to remove 
phenylpropanolamine from the market. As a result, many firms 
voluntarily discontinued marketing products containing it. Because MAPA 
specifically addresses phenylpropanolamine and there remain legitimate 
veterinary uses for it that will ensure some level of its continued 
production and availability, this action continues to apply to 
phenylpropanolamine.
    MAPA will affect persons who sell drug products containing 
pseudoephedrine or phenylpropanolamine to the public. This includes 
retail distributors and persons required to submit mail order reports. 
For retail distributors, single transactions containing 9 grams or more 
of pseudoephedrine or phenylpropanolamine as base are regulated 
transactions. Single transactions in which a package contains more than 
3 grams of pseudoephedrine base or more than 3 grams of 
phenylpropanolamine base are also regulated transactions. Above-
threshold transactions will still be permitted, but will be subject to 
all the requirements of a regulated transaction, including registration 
of the distributor--as selling over-threshold amounts of these products 
voids the retail distributor exemption (21 CFR 1309.24(e)), 
identification of customers (21 CFR 1310.07), maintenance of records 
(21 CFR 1310.04), and the filing of reports with the Administration (21 
CFR 1310.05, 1310.06). It is important to note, however, that many 
retail distributors have already voluntarily limited their sales in a 
single transaction to amounts equal to or less than those finalized in 
this rulemaking to help prevent diversion of these products for the 
illicit manufacture of methamphetamine and amphetamine.
    For those required to submit mail order reports, both the 9 gram 
transaction threshold and the 3 gram package size for pseudoephedrine 
and phenylpropanolamine drug products apply to every transaction--
regardless of whether the transaction is one that must be reported. 
Single transactions of 9 grams or more of pseudoephedrine or 
phenylpropanolamine as base are regulated transactions and single 
transactions of package sizes containing more than 3 grams of 
pseudoephedrine or phenylpropanolamine as base are regulated 
transactions. Regulated transactions subject the distributor to the 
following requirements--identification of the customer (21 CFR 
1310.07), recordkeeping (21 CFR 1310.04), and reporting (21 CFR 1310.05 
and 1310.06), in addition to the requirement to submit monthly reports 
of all transactions (21 U.S.C. 830(b)(3)).
    MAPA added language requiring monthly mail order reports for export 
transactions with nonregulated persons involving ephedrine, 
pseudoephedrine, phenylpropanolamine, and drug products containing them 
which use or attempt to use the Postal Service, or any private or 
commercial carrier. Every export transaction for these chemicals and 
for drug products containing them must be reported on a monthly basis 
unless the export transaction is exempt. Exempt export transactions 
include those reported on a DEA Form 486 and those for which the 
Administrator has waived monthly reporting.
    To reduce the burden on those who are subject to the monthly mail 
order reporting requirement under 21 U.S.C. 830(b)(3), MAPA added 
exemptions to this requirement. These exemptions include distributions 
of samples of drug products, deliveries of prescriptions to consumers 
by retail distributors, distributions of drug products to long term 
care facilities and their residents, mail order prescription 
deliveries, exports reported to DEA on a Form 486, and any quantity, 
method, or type of distribution of a specific listed chemical or group 
of listed chemicals which the Attorney General has excluded by 
regulation from this reporting requirement. These exemptions were 
previously cited in the section of this rulemaking titled, ``Why is DEA 
publishing a final rule?'' The Administrator of DEA, through the 
delegation of authority from the Attorney General, may exclude by 
regulation from the mail order reporting requirement any quantity, 
method, or type of distribution of listed chemicals (including specific 
formulations or drug products) for which such reporting is considered 
not necessary for the enforcement of law. DEA will consider any 
suggestions submitted regarding additional exemptions to the reporting 
requirement under 21 U.S.C. 830(b)(3) that may be warranted.

Technical Amendment

    The final regulations implementing the provisions of the 
Comprehensive Methamphetamine Control Act (MCA) amended the waiver of 
the retail registration activity found in 21 CFR 1309.24(e) to include 
a statement that the threshold for retail distributions of ephedrine, 
pseudoephedrine and phenylpropanolamine is 24 grams in a single 
transaction, regardless of whether the product meets the definition of 
``ordinary over-the-counter pseudoephedrine or phenylpropanolamine 
product.'' As MAPA amends those thresholds, as previously described, a 
conforming technical amendment to 21 CFR 1309.24(e) is being made to 
remove the reference to the 24 gram threshold.

Regulatory Certifications

Administrative Procedure Act (5 U.S.C. 553)

    An agency may find good cause to exempt a rule from certain 
provisions of the Administrative Procedure Act (5 U.S.C. 553), 
including notice of proposed rulemaking and the opportunity for public 
comment, if it is determined to be unnecessary, impracticable, or 
contrary to the public interest. The requirements of MAPA included in 
this rulemaking were set out in such detail as to be self-implementing. 
Therefore the changes in this rulemaking provide conforming amendments 
to make the language of the regulations consistent with that of the 
law. Hence, DEA finds it unnecessary to publish for public notice and 
comment.

Regulatory Flexibility Act

    The Deputy Assistant Administrator, Office of Diversion Control, 
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 this regulation 
will not have a significant economic impact on a substantial number of 
small entities. This regulation will not adversely impact the public's 
access to drug products containing pseudoephedrine and 
phenylpropanolamine. At the same time, this regulation will limit the 
potential for diversion of these products to the clandestine 
manufacture of methamphetamine and amphetamine.

[[Page 57803]]

For mail order reporting, this action exempts from the reporting 
requirements a number of transactions that currently must be reported, 
thus reducing the overall reporting burden on many small businesses.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles of 
Executive Order 12866 Section 1(b). DEA has determined that this is not 
a significant regulatory action. Therefore, this action has not been 
reviewed by the Office of Management and Budget.

Executive Order 12988

    This rulemaking meets the applicable standards set forth in 
Sections 3(a) and 3(b)(2) of Executive Order 12988.

Executive Order 13132

    This action has been analyzed in accordance with the principles and 
criteria in Executive Order 13132, and it has been determined that this 
rule does not have federalism implications and, therefore, does not 
warrant the preparation of a Federalism Assessment.

Paperwork Reduction Act

    For those required to report under 21 U.S.C. 830(b)(3), MAPA adds 
the requirement of submitting a monthly report for certain export 
transactions with nonregulated persons involving ephedrine, 
pseudoephedrine, phenylpropanolamine, and drug products containing 
them. However, to reduce the burden on those affected, MAPA exempts 
monthly reporting of exports of the above list I chemicals and drug 
products containing them when they are reported to DEA pursuant to 21 
U.S.C. 954 and 971.
    MAPA further reduces the reporting burden on the regulated industry 
required to submit reports under 21 U.S.C. 830(b)(3) by exempting 
certain other transactions involving ephedrine, pseudoephedrine, 
phenylpropanolamine and drug products containing them from the 
requirement to submit reports as discussed in this rulemaking.
    At this time it is not feasible for DEA to determine the extent of 
the impact of this rulemaking on the regulated industry. Once DEA has 
determined the impact, it will make the necessary filing with the 
Office of Management and Budget to adjust the burden of this 
information collection for the affected industry.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule 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 $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

List of Subjects

21 CFR Part 1300

    Chemicals, Definitions, Drug traffic control.

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, List I 
and List II chemicals, Security measures.

21 CFR Part 1310

    Drug traffic control, Exports, Imports, List I and List II 
chemicals, Reporting and recordkeeping requirements.


0
For the reasons set out above, 21 CFR parts 1300, 1309 and 1310 are 
amended as follows:

PART 1300--DEFINITIONS [AMENDED]

0
1. The authority citation for Part 1300 continues to read as follows:

    Authority: 21 U.S.C. 802, 871(b), 951, 958(f).


0
2. Section 1300.02 is amended by revising paragraph (b)(28)(i)(D)(2) 
and by adding paragraphs (b)(33) and (b)(34) to read as follows:


Sec.  1300.02  Definitions relating to listed chemicals.

* * * * *
    (b) * * *
    (28) * * *
    (i) * * *
    (D) * * *
    (2) The quantity of ephedrine, pseudoephedrine, 
phenylpropanolamine, or other listed chemical contained in the drug 
included in the transaction or multiple transactions equals or exceeds 
the threshold established for that chemical, except that the threshold 
for any sale of products containing pseudoephedrine or 
phenylpropanolamine by retail distributors or by distributors required 
to submit reports by Sec.  1310.03(c) shall be 9 grams of 
pseudoephedrine or 9 grams of phenylpropanolamine in a single 
transaction and sold in package sizes of not more than 3 grams of 
pseudoephedrine base or 3 grams of phenylpropanolamine base. For 
combination ephedrine products the threshold for any sale by retail 
distributors or by distributors required to submit reports by Sec.  
1310.03(c) shall be 24 grams of ephedrine in a single transaction.
* * * * *
    (33) The term drug product means an active ingredient in dosage 
form that has been approved or otherwise may be lawfully marketed under 
the Food, Drug, and Cosmetic Act for distribution in the United States.
    (34) The term valid prescription means a prescription that is 
issued for a legitimate medical purpose by an individual practitioner 
licensed by law to administer and prescribe the drugs concerned and 
acting in the usual course of the practitioner's professional practice.

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS 
AND EXPORTERS OF LIST I CHEMICALS [AMENDED]

0
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.


0
2. Section 1309.24 is amended by revising paragraph (e) to read as 
follows:


Sec.  1309.24  Waiver of registration requirement for certain 
activities.

* * * * *
    (e) The requirement of registration is waived for any retail 
distributor whose activities with respect to List I chemicals are 
limited to the distribution of below-threshold quantities of a 
pseudoephedrine, phenylpropanolamine, or combination ephedrine product 
that is regulated pursuant to Sec.  1300.02(b)(28)(i)(D) of this 
chapter, in a single transaction to an individual for legitimate 
medical use, irrespective of whether the form of packaging of the 
product meets the definition of ``ordinary over-the-counter 
pseudoephedrine or

[[Page 57804]]

phenylpropanolamine product'' under Sec.  1300.02(b)(31) of this 
chapter.
* * * * *

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES [AMENDED]

0
1. The authority citation for part 1310 continues to read as follows:

    Authority: 21 U.S.C. 802, 830, 871(b).


0
2. Section 1310.03 is amended by revising paragraph (c) to read as 
follows:


Sec.  1310.03  Persons required to keep records and file reports.

* * * * *
    (c) Each regulated person who engages in a transaction with a 
nonregulated person or who engages in an export transaction that 
involves ephedrine, pseudoephedrine, or phenylpropanolamine, 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.

0
3. Section 1310.04 is amended by revising paragraphs (f)(1)(ii), (c)(1) 
and (c)(2), (d)(2), (e)(1) and (e)(2), and (f)(2) to read as follows:


Sec.  1310.04  Maintenance of records.

* * * * *
    (f) * * *
    (1) * * *
    (ii) * * *

------------------------------------------------------------------------
                Chemical                       Threshold by weight
------------------------------------------------------------------------
 (C) * * *
 (1) Distributions by retail              9 grams, and sold in package
 distributors.                            sizes of not more than 3 grams
                                          of pseudoephedrine base.
 (2) Distributions by persons required    9 grams, and sold in package
 to report under Sec.   1310.03(c) of     sizes of not more than 3 grams
 this part.                               of pseudoephedrine base.
 
                              * * * * * * *
 (D) * * *
 (2) Distributions by persons required    9 grams, and sold in package
 to report under Sec.   1310.03(c) of     sizes of not more than 3 grams
 this part.                               of pseudoephedrine base.
 
                              * * * * * * *
 (E) * * *
 (1) Distributions by retail              9 grams, and sold in package
 distributors.                            sizes of not more than 3 grams
                                          of phenylpropanolamine base.
 (2) Distributions by persons required    9 grams, and sold in package
 to report under Sec.   1310.03(c) of     sizes of not more than 3 grams
 this part.                               of phenylpropanolamine base.
 
                              * * * * * * *
 (F) * * *
 (2) Distributions by persons required    9 grams, and sold in package
 to report under Sec.   1310.03(c) of     sizes of not more than 3 grams
 this part.                               of phenylpropanolamine base.
------------------------------------------------------------------------

* * * * *

0
4. Section 1310.05 is amended by adding new paragraphs (f) and (g) to 
read as follows:


Sec.  1310.05  Reports.

* * * * *
    (f) Except as provided in paragraph (g) of this section, the 
following distributions to nonregulated persons, and the following 
export transactions, are not subject to the reporting requirements in 
Sec.  1310.03(c):
    (1) Distributions of sample packages of drug products when those 
packages contain not more than two solid dosage units or the equivalent 
of two dosage units in liquid form, not to exceed 10 milliliters of 
liquid per package, and not more than one package is distributed to an 
individual or residential address in any 30-day period.
    (2) Distributions of drug products by retail distributors that may 
not include face-to-face transactions to the extent that such 
distributions are consistent with the activities authorized for a 
retail distributor as specified in Sec.  1300.02(b)(29) of this 
chapter.
    (3) Distributions of drug products to a resident of a long term 
care facility or distributions of drug products to a long term care 
facility for dispensing to or for use by a resident of that facility.
    (4) Distributions of drug products in accordance with a valid 
prescription.
    (5) Exports which have been reported to the Administrator under 
Sec. Sec.  1313.31 and 1313.32 of this chapter or which are subject to 
a waiver granted under Sec.  1313.21 of this chapter.
    (g) The Administrator may revoke any or all of the exemptions 
listed in paragraph (f) of this section for an individual regulated 
person if the Administrator finds that drug products distributed by the 
regulated person are being used in violation of the regulations in this 
chapter or the Controlled Substances Act. The Administrator will notify 
the regulated person of the revocation, as provided in Sec.  1313.41(a) 
of this chapter. The revocation will be effective upon receipt of the 
notice by the person. The regulated person has the right to an 
expedited hearing regarding the revocation, as provided in Sec.  
1313.56(a) of this chapter.

    Dated: September 29, 2003.
Laura M. Nagel,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 03-25100 Filed 10-6-03; 8:45 am]
BILLING CODE 4410-09-P