Guidance for industry: Prescription Drug Marketing Act (PDMA) requirements, questions and answers

Original publisher: Rockville, MD: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research: Office of the Commissioner: Office of Regulatory Affairs, [2006] OCLC Number: (OCoLC)466167325 Excerpt: ... ADDENDUM to FDA's Guidance for Industry: PDMA Pedigree Requirements - Questions and Answers Related to the Preliminary Injunction ordered 12 / 5 / 06 in RXUSA Wholesalers, Inc. v. HHS 12.15.06 A. What is affected by the preliminary injunction?�21 CFR § 203.50 ( a ). The court order enjoins FDA from implementing 21 CFR § 203.50 ( a ). 21 CFR § 203.50 ( a ) ( 6 ), states that information regarding " each prior transaction involving the drug, starting with the manufacture " be included in the pedigree. However, while the preliminary injunction is in effect, pedigrees shall include information regarding prior transactions going back to the manufacturer or the last ADR that sold, purchased, or traded the prescription drugs. FDA encourages wholesalers to include information regarding each prior transaction going back to the manufacturer when that information is available.�21 CFR § 203.50 ( a ) ( 1 )-( 5 ). The court order also enjoins FDA from implementing the language in 21 CFR § 203.50 that requires pedigrees to include lot and control numbers, dosage, container size, and number of containers. As described in more detail below, however, the preliminary injunction does not affect the statutory requirement that pedigrees contain the dates of all listed transactions and the names and addresses of all parties involved in those transactions. In addition, since the court did not enjoin implementation of 21 CFR § 203.3 ( u ), a written agreement between a manufacturer and a wholesaler may limit ADR status to a particular lot number ( s ), dosage, or the number or size of the containers of prescription drugs. We also note that, without the lot number on the pedigree, it would be extremely difficult to track the inventory ...