FDA to Begin Accepting Drug Secure Supply Chain Pilot Applications in September

The Food and Drug Administration will soon begin its secure supply chain pilot program for pharmaceuticals, it said in a Federal Register notice set for publication Aug. 20. The pilot, originally announced in 2009 (see 09011620), will allow expedited entry for finished drug products and active pharmaceutical ingredients (APIs) from participating importers. FDA said it will accept applications beginning Sept. 16 until Dec. 31, and will begin the pilot in February 2014. The agency intends to run the pilot for two years, until February 2016, it said.

Through the voluntary pilot program, FDA said it plans to increase the rate at which entries of finished drugs and APIs selected for the program are given a “may proceed” without human entry review or examination. That will “increase the likelihood” of expedited entry when products covered by the program are imported, FDA said. FDA said it will pick no more than 100 participants, with no more than five drug products per applicant. Because of requirements related to the Customs-Trade Partnership Against Terrorism (C-TPAT), only importers from the U.S., Canada, and Mexico will be eligible, FDA has confirmed (see 12070303).

Requirements Include C-TPAT Tier II/III, Recordkeeping, Paperless Entry Filing

Applications should be submitted electronically in PDF format using the Electronic Common Technical Document format and the Electronic Submissions Gateway, FDA said. FDA said to be selected as a participant in the secure supply chain pilot, applicants must meet the following criteria:

• Must submit a complete application using FDA Form 3676 (here) and be the sponsor of the new drug application (NDA) or abbreviated new drug application (ANDA), or be the foreign manufacturer of the imported finished drug product or API.
• If the ultimate consignee is an establishment subject to Section 510 of the Food, Drug and Cosmetic Act, then it must have complied for the past three years with FDA registration, drug listing, and current good manufacturing practice requirements.
• If the drug is a finished dosage form, then ultimate consignee for the drug must be identified in the approved NDA or ANDA.
• If the drug is an API, then the source must be an acceptable source per the approved NDA or ANDA, and the API must be used in the manufacture of the FDA-approved drug product.
• The finished drug product or API must be imported from the foreign manufacturer identified on the pilot application, must arrive through the identified port of entry and port of arrival, must use the identified customs broker or entry filer, and must be intended for the identified ultimate consignee.
• The foreign manufacturer on the pilot application must be in compliance with FDA drug requirements.
• The importer of record must be a validated Tier II or Tier III C-TPAT participant.
• The primary and secondary contacts identified in the application must be able to answer questions and resolve issues raised by FDA. The primary contact has to be the sponsor or the U.S. agent for the sponsor.
• The applicant has to have a plan to correct any concerns FDA has on its secure supply chain or specific importations.
• The applicant has to have a plan for recalling or correcting any finished drug products or APIs that don’t meet FDA requirements.
• The applicants must comply with FDA recordkeeping requirements, and on top of that has to keep records confirming information given in their pilot applications, like documentation of C-TPAT validation status.
• The customs broker or entry filer identified on the pilot application has to be qualified for paperless entry filing to FDA’s Operational and Administrative System for Import Support.

FDA said it will assign a qualifier to each selected pilot program application. Each customs broker or entry filer will transmit the qualifier when filing the entry for the pilot. The qualifier will accompany an Affirmation of Compliance code that FDA has designated as a secure supply chain, the agency said. Once accepted into the pilot, the applicant must notify FDA of any changes to the information in the application, it said.

Agency Can Revoke Participation

FDA said it will periodically examine records and do random field examinations to audit pilot participants’ shipments. The agency will end a company’s participation if the applicant, foreign manufacturer, or ultimate consignee (1) gets a communication from FDA (like a warning letter or untitled letter) citing violations of the Food Drug and Cosmetic Act relating to drug products, or (2) fails to comply with pilot requirements. Termination of participation in the pilot will mean a return to the normal manual drug entry review process, FDA said.

Pilot to Inform Decision on Permanent Secure Supply Chain Program

FDA will evaluate the pilot based on timeframes for passage of drugs through the entry process, the level of adherence by pilot participants to program criteria, and the impact of the pilot program. The agency will then decide whether to implement a permanent secure supply chain program, it said.