By Kevin Zarnick, Pharmaceutical Sales Manager, Thermo Fisher Scientific
The U.S. Food and Drug Administration (FDA) issued the Prescription Drug Marketing Act of 1987 (PDMA) which was then modified by the Prescription Drug Amendments of 1992. Included was Section 503(e)(1)(A) which establishes the pedigree requirement for prescription drugs.
A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the date of those transactions and the names and addresses of all parties involved. In addition to what the federal government already mandates, individual states have begun implementing their own pedigree laws. For example, California’s Pedigree Law, which goes into effect 2015, requires electronic track and trace and item-level serialization.
The objective of this white paper is to provide background to assist those functions involved in implementing serialization methodologies for pharmaceutical products. Because the topic is extremely broad in nature, this paper will focus specifically on how checkweighers can play a significant role in addressing track and trace requirements for package components.