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Information on Foreign Chain of Distribution for Ephedrine

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Information on Foreign Chain of Distribution for Ephedrine 10168 Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations PART 524—OPHTHALMIC AND DEPARTMENT OF JUSTICE controlled substances must register with TOPICAL DOSAGE FORM NEW DEA (unless exempt) and comply with ANIMAL DRUGS Drug Enforcement Administration the applicable requirements for the activity. The CSA as amended also 21 CFR Part 1313 ■ 34. The authority citation for 21 CFR requires DEA to regulate the part 524 continues to read as follows: [Docket No. DEA–295F] manufacture, distribution, import, and export of chemicals that may be used to Authority: 21 U.S.C. 360b. RIN 1117–AB07 manufacture controlled substances illegally. Listed chemicals that are § 524.2481 [Redesignated as § 524.2483] Information on Foreign Chain of classified as List I chemicals are Distribution for Ephedrine, ■ important to the manufacture of 35. Redesignate § 524.2481 as Pseudoephedrine, and § 524.2483. controlled substances. Those classified Phenylpropanolamine as List II chemicals may be used to § 524.2483 [Amended] AGENCY: Drug Enforcement manufacture controlled substances. Administration (DEA), Justice. On March 9, 2006, the President ■ 36. In paragraph (b) of newly signed the Combat Methamphetamine ACTION: Final rule. redesignated § 524.2483, remove Epidemic Act of 2005 (CMEA), which is ‘‘015914, 053501, and 054925’’ and in its SUMMARY: The Drug Enforcement Title VII of the USA PATRIOT place add ‘‘000010, 015914, and Administration (DEA) is finalizing, Improvement and Reauthorization Act 054925’’. without change, the Notice of Proposed of 2005 (Pub. L. 109–177). The changes Rulemaking published in the Federal made by this rule are needed to PART 526—INTRAMAMMARY DOSAGE Register on March 31, 2008 (73 FR implement the statutory provisions. FORMS 16793). The Combat Methamphetamine This Final Rule amends the language of Epidemic Act of 2005 (CMEA) requires the regulations to be consistent with ■ 37. The authority citation for 21 CFR DEA to collect from importers of that of the statute. part 526 continues to read as follows: ephedrine, pseudoephedrine, and Import/Export Declaration Authority: 21 U.S.C. 360b. phenylpropanolamine all information Requirements known to the importer on the foreign § 526.363 [Amended] chain of distribution of the chemical Under existing DEA regulations (21 from the manufacturer to the importer. CFR part 1313), importers of listed ■ 38. In paragraph (b) of § 526.363, This rule amends DEA regulations to chemicals are required to provide DEA remove ‘‘000856’’ and in its place add incorporate the requirement for this with advance notification of imports ‘‘000010’’. information. unless the importer has met the requirements as a regular importer of § 526.365 [Amended] DATES: Effective Dates: This Final Rule the listed chemical; for regular is effective May 4, 2010. importers, the notification must be filed ■ 39. In paragraph (b) of § 526.365, FOR FURTHER INFORMATION CONTACT: by the date of importation. In the remove ‘‘000856’’ and in its place add Mark W. Caverly, Chief, Liaison and importation declaration (DEA Form ‘‘000010’’. Policy Section, Office of Diversion 486), the importer must provide ■ 40. In § 526.464a, revise the section Control, Drug Enforcement information on the chemical (name, size heading and paragraph (c) to read as Administration, 8701 Morrissette Drive, and weight of the container, number of Springfield, VA 22152, Telephone (202) follows: containers, total weight of chemical), 307–7297. importation (date, foreign port of § 526.464a Cloxacillin benzathine. SUPPLEMENTARY INFORMATION: shipment, United States port of entry) * * * * * and the foreign supplier (name, address, Background and Legal Authority contact information). (c) Sponsor. See No. 000010 in DEA implements the Comprehensive CMEA imposes several new § 510.600(c) of this chapter for use in Drug Abuse Prevention and Control Act requirements on imports of listed dairy cows. of 1970, often referred to as the chemicals. CMEA amended 21 U.S.C. * * * * * Controlled Substances Act (CSA) and 971, ‘‘Notification, suspension of the Controlled Substances Import and shipment, and penalties with respect to § 526.1130 [Amended] Export Act (CSIEA) (21 U.S.C. 801–971), importation and exportation of listed as amended. DEA publishes the chemicals,’’ to require DEA to collect ■ 41. In § 526.1130, in paragraph (b), implementing regulations for these information regarding persons to whom remove ‘‘000856’’ and in its place add statutes in Title 21 of the Code of the U.S. importer, exporter, broker, or ‘‘000010’’; and in paragraph (c)(3), Federal Regulations (CFR), parts 1300 to trader transfers the listed chemical, remove the first sentence. 1399. These regulations are designed to actual quantities shipped, and the date Dated: February 26, 2010. ensure that there is a sufficient supply the shipment occurred. If the person to Steven D. Vaughn, of controlled substances for legitimate whom the listed chemical is to be medical, scientific, research, and transferred is not a regular customer of Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. industrial purposes and to deter the the U.S. importer or exporter, then the diversion of controlled substances to importer or exporter must notify DEA [FR Doc. 2010–4560 Filed 3–4–10; 8:45 am] illegal purposes. The CSA mandates that no later than 15 days before the BILLING CODE 4160–01–S DEA establish a closed system of control transaction is to take place. Further, if for manufacturing, distributing, and the person to whom the chemical is to dispensing controlled substances. Any be transferred changes subsequent to person who manufactures, distributes, initial notification of DEA, or if the dispenses, imports, exports, or conducts amount of the chemical to be transferred research or chemical analysis with increases, the importer or exporter shall VerDate Nov<24>2008 14:25 Mar 04, 2010 Jkt 220001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\FR\FM\05MRR1.SGM 05MRR1 erowe on DSK5CLS3C1PROD with RULES Federal Register / Vol. 75, No. 43 / Friday, March 5, 2010 / Rules and Regulations 10169 update the notice to DEA to identify the to state that importers of ephedrine, Safety of medication manufactured most recent prospective transferee or the pseudoephedrine, and overseas: One commenter stated that he most recent quantity or both (as the case phenylpropanolamine must provide supported the rule because he believed may be) and may not transfer the listed information known to them on the chain that improving drug safety can save chemical until after the expiration of the of distribution from the manufacturer to lives. The commenter also asserted that 15-day period beginning on the date on the importer. DEA also proposed to add ‘‘this rule has the potential to improve which the update is submitted to DEA, a new 21 CFR 1313.42 to cover the safety of the industry even further by except that such 15-day restriction does provisions of paragraphs (h)(2) and putting the burden of finding the foreign not apply if the prospective transferee (h)(3) on orders to prohibit imports from chain of distribution on the importer.’’ identified in the update is a regular foreign manufacturers and distributors The commenter emphasized his concern customer. These changes apply to all who refuse to cooperate with requests with the safety of medications listed chemicals. On April 9, 2007, DEA for information. manufactured in foreign countries and published an Interim Final Rule with asserted that the Food and Drug Revision of DEA Form 486: Import/ Request for Comment codifying these Administration (FDA) does not have Export Declaration for List I and List II provisions (72 FR 17401). Subsequently, adequate resources to regulate overseas Chemicals due to requests from the regulated manufacturing facilities, and believed industry, DEA temporarily stayed To comply with the changes made to this rule could be beneficial in that certain provisions of that rule (72 FR the CSA by CMEA, DEA proposed to regard. The commenter believed that the 28601, May 22, 2007). That Interim establish a new DEA Form 486A to be reporting of information about where a Final Rule became effective June 8, used by persons importing ephedrine, drug comes from is of interest not only 2007. pseudoephedrine, or to the importer, but to all parties phenylpropanolamine, or drug products concerned, including practitioners who Imports of Ephedrine, containing ephedrine, pseudoephedrine, prescribe those medications to their Pseudoephedrine, and or phenylpropanolamine. This new patients. The commenter believed that it Phenylpropanolamine form responds to the requirement is useful to know that medications came CMEA added a new paragraph (h) to regarding the foreign chain of from ‘‘trustworthy’’ facilities, and that 21 U.S.C. 971 that applies specifically to distribution discussed above, as well as such a requirement would be a ‘‘small the importation of ephedrine, to requirements implemented regarding price to pay’’ for protecting lives. pseudoephedrine, and import quotas for ephedrine, DEA Response: DEA appreciates the phenylpropanolamine. In paragraph pseudoephedrine, and commenter’s support. Regarding the (h)(1), the Act states that the import phenylpropanolamine. In a separate safety of medications manufactured in declaration ‘‘shall include all rulemaking, ‘‘Import and Production foreign countries, DEA does not have information known to the importer on Quotas for Certain List I Chemicals’’ jurisdiction regarding foreign the chain of distribution
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