Source: https://www.deadiversion.usdoj.gov/fed_regs/rules/2003/fr1007.htm
Timestamp: 2018-10-19 21:31:51
Document Index: 703830652

Matched Legal Cases: ['arts 1300', '§ 1310', '§ 1310', 'arts 1300', '§ 1310', '§ 1310', '§ 1300', '§ 1300', '§ 1310', '§ 1310', '§ 1310', 'art 9', '§ 1310', 'art. 9', '§ 1310', 'art 9', '§ 1300', '§ 1313', '§ 1313']

2003 - 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
RESOURCES > Federal Register Notices > Rules - 2003 > 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
FR Doc 03-25100
[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]
21 CFR Parts 1300, 1309, and 1310
[Docket No. DEA-210F] RIN 1117-AA69
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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.
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]:
(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)].
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]:
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).
At the retail level, all drug products containing pseudoephedrine or phenylpropanolamine that do not meet
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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.
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?"
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 § § 1310.03 and 1310.05 to reflect the revised reporting requirements for mail order distributions. Specifically, DEA is amending § 1310.05 to explicitly exempt from the reporting requirements the low-risk categories of mail order transactions previously listed.
Number of Tablets That Constitute a Regulated Transaction for
Dosage Units of Marketed Products *
* Calculated as base.
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)).
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.
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.
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.
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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.
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.
Chemicals, Definitions, Drug traffic control.
For the reasons set out above, 21 CFR parts 1300, 1309 and 1310 are amended as follows:
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:
(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 § 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 § 1310.03(c) shall be 24 grams of ephedrine in a single transaction.
(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 § 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
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phenylpropanolamine product" under § 1300.02(b)(31) of this chapter.
§ 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 § 1310.05 of this part.
(2) Distributions by persons required to report under § 1310.03(c) of this part 9 grams, and sold in package sizes of not more than 3 grams of pseudoephedrine base.
(2) Distributions by persons required to report under § 1310.03(c) of this part. 9 grams, and sold in package sizes of not more than 3 grams of pseudoephedrine base.
(1) Distributions by retail distributors
9 grams, and sold in package sizes of not more than 3 grams of phenylpropanolamine base.
(2) Distributions by persons required to report under § 1310.03(c) of this part 9 grams, and sold in package sizes of not more than 3 grams of phenylpropanolamine base.
(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 § 1300.02(b)(29) of this chapter.
(5) Exports which have been reported to the Administrator under § § 1313.31 and 1313.32 of this chapter or which are subject to a waiver granted under § 1313.21 of this chapter.