By Michelle L. Oxman, J.D., LL.M.
First responders and trading partners that transfer drugs to first responders will not be subject to enforcement action by the FDA for failure to comply with certain “track and trace” requirements imposed by federal Food, Drug and Cosmetic Act (FDC Act) Sec. 582 if they meet certain conditions. In a new FDA Guidance issued on February 29, 2016, entitled “Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act — Compliance Policy Guidance for Industry,” the agency notified the industry and the public that until further notice, it would not enforce the requirement to provide tracking information in transactions with or between first responders (Notice, 81 FR 10260, February 29, 2016).
The DSCSA. On March 1, 2016, the FDA’s implementation of the Drug Supply Chain Security Act (DSCSA), enacted as title II of P.L. 113-54, enters a new phase in which dispensers of drugs and their trading partners will be expected to receive and provide tracking information on each drug sold. The February 29 guidance recognizes that “first responders,” i.e., entities working outside an institution who provide emergency medical services, may not be able to comply with the obligations to receive and maintain the necessary tracking information. Therefore, the FDA will not enforce the requirements to give or receive and maintain tracking information where one or both of the parties are first responders.
The guidance will apply if certain conditions are met. First, the dispenser who transfers the drug to a first responder must capture and maintain the product tracing information for the transaction before, during, or immediately after the transaction. Second, the dispenser must retain the tracing information for six years from the date of the transaction. Third, the dispenser must provide the tracing information either to the first responder or to the HHS Secretary on request, within two business days of the request or any other reasonable time that the Secretary may specify.
Under the guidance, the FDA will not take enforcement action against a trading partner that transfers ownership to a first responder who is not authorized to dispense the drug under federal FDC Act Sec. 581(2)(D). Nevertheless, all other requirements of Section 582 will be enforced, including the requirements that manufacturers, wholesale distributors, repackagers and dispensers verify suspect or illegitimate product, including quarantine, notification, investigation, and recordkeeping under the statute.
Application to first responders. First responders will not be subjected to enforcement action if they receive ownership of product without receiving or capturing the tracing information, transfer product to another first responder without providing, capturing, or receiving the tracing information, or fail to conduct verification of suspect or illegitimate product. Still, if a first responder believes that it has received suspect or illegitimate product, the FDA “strongly recommends” that it take action to prevent its distribution to patients.
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