FDA Defines Parties Involved in Manufacture and Distribution of Drugs
(Thursday, July 7, 2022)
Manufacture and distribution of drugs and biologics involve various parties with diverse responsibilities, and it was always confusing as to what regulatory requirements apply to them, till now. Who needs to register with FDA, who needs to pay fees, who needs to be licensed by other authorities, etc.? This week, FDA’s newest Guidance Document list the definitions and applicable regulations for each party involved in manufacture, license, warehousing, wholesale and retail distribution, salvaging, and many other roles in the pharmaceutical supply chain. The guidance details the applicable regulations for each kind of party from the applicants of NDA, BLA, and ANDA, to all the parties up- and downstream the supply chain. FDA uses the term “Trading Partners” for all the parties involved in drug supply change to differentiate them from the “Development Partners” such as CROs, and preclinical vendors. The Trading Partners are further distributed into nine major categories and several sub-categories based on the scope of responsibility. For each category, FDA defines specific roles, registration requirements, legal responsibilities, and reporting requirements. The guidance was urgently needed as too many misperceptions and confusions dominate the supply chain leading to delays, costs, and logistical challenges. The guidance document should be used for creating SOPs and training materials for the drug supply chain and should be the primary reference document for any questions about the regulatory requirements.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC