[Federal Register: October 7, 2003 (Volume 68, Number 194)]
[Rules and Regulations]
[Page 57799-57804]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07oc03-7]
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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