FDA Issues Guidance on 3PL Annual Reporting Requirements for Drugs

The Food and Drug Administration issued a draft guidance document (here) on annual reporting requirements under the Drug Supply Chain Security Act for prescription drug wholesale distributors and third-party logistics providers, it said (here). The questions and answers document clarifies that the reporting requirements apply only to 3PLs “that provide or coordinate warehousing, or other logistics services” for “human prescription drugs in finished dosage form.” If a 3PL facility “handles only bulk drug substances that are free form active pharmaceutical ingredients (API) and have yet to undergo manufacturing, processing, or packaging to become the finished dosage form of the drug, the 3PL facility does not need to report,” FDA said. Comments are due March 13.