The US Food and Drug Administration (FDA) has issued guidance for industry on registration for human drug compounding outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act.
The guidance is intended for outsourcing facilities that compound human drugs. A facility that compounds sterile drugs may elect to register with FDA as an outsourcing facility under section 503B of the Act. The guidance focuses on electronic submission of establishment registration information. It describes the process for registering as an outsourcing facility and provides instruction on how outsourcing facilities should report to FDA the products they compound.
Each facility at a separate geographic location or address must register separately. Facilities that elect to register with FDA as outsourcing facilities should submit registration information using the existing Structured Product Labelling (SPL) format.
After initial registration, facilities must register annually, between October 1 and December 31 of each year, to be recognized as a registered outsourcing facilities. FDA has created a new SPL category of business operation for outsourcing facilities. All outsourcing facilities should submit establishment registration information using the business operation ‘Human Drug Compounding Outsourcing Facility’. If a facility chooses to register as an outsourcing facility, it is required by section 503B(b) of the FD&C Act, with information covering the name of the facility, place of business, unique facility identifier, contact details. Further there should be details on whether the facility intends to compound products on FDA’s drug shortage list and whether the facility compounds from bulk drug substances, stated the regulator.
FDA encourages outsourcing facilities to register using its electronic registration system, as indicated in III.B.1. However, because registration is a new requirement for those outsourcing facilities that elect to register under section 503B, the regulator wants to encourage registration of outsourcing facilities and has provided an alternative interim registration mechanism for use after initial passage of the Drug Quality and Security Act (DQSA).
If an outsourcing facility new to FDA’s electronic registration method chooses to register by this alternative interim method, it insists on the contact details. This alternative interim registration method is only intended for use in the near term, while outsourcing facilities unfamiliar with registration need to familiarize themselves with the method described in section III.B.1. It encourages outsourcing facilities that chooses to use this alternative interim method to begin using the method no later than September 30, 2014, stated the regulatory authority.
The information collected from the outsourcing facility registration, will be published online by section 503B(b)(1)(B)(ii) of the FD&C Act. It will include the name of each registered outsourcing facility.
Section 503B(b)(3) of the FD&C Act requires outsourcing facilities to register by electronic means unless the regulatory authority grants a request for a waiver of this requirement because use of electronic means is not reasonable for the person requesting the waiver. It does not anticipate many instances in which electronic submission of registration information will not be reasonable for the person requesting the waiver. However, if you are granted a waiver, the regulatory authority would instruct on how to submit the required registration information.