The FDA has received numerous questions “about whether entities engaged in various types of activities (e.g., a facility that is compounding only non-sterile drugs or only repackaging biological products) should register as an outsourcing facility.”  Firms are still confused about whether they qualify to register and this new document entitled, Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug and Cosmetic Act (here) was released from FDA today in hopes of clarifying this issue.

FDA outlines the definition of an outsourcing facility under 503B of the FD&C Act as follows:

A facility at one geographic location or address that— (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section.

The Guidance delineates 11 conditions that must be met by outsourcing facilities and must be met to qualify for the exemptions afforded for adequate labeling requirements under the Act.  In addition, FDA reminds registrants that an outsourcing facility is subject to current good manufacturing practices (cGMPs) and is subject to periodic inspection by the FDA.  The key issue is that the outsourcing facility must produce sterile drug products in order to be defined as such.

The Guidance also states:

If you do not intend for all drugs compounded at your facility to be compounded in accordance with section 503B and comply with CGMP requirements, you should not register as an outsourcing facility under section 503B.  In addition, entities considering registering as outsourcing facilities should consider the following:

  • To meet the definition of an outsourcing facility, the facility must be engaged in the compounding of sterile human drugs.
  • The definition of compounding in section 503B(d)(1) does not include repackaging.
  • For purposes of section 503B, a drug, including a sterile drug, does not include a biological product subject to licensure under section 351 of the Public Health Service Act (PHS Act), or an animal drug subject to approval under section 512 of the FD&C Act.

The FDA advises, “you should not register a facility as an outsourcing facility if the only activities conducted at the facility are repackaging, compounding non-sterile drugs, compounding animal drugs, or mixing, diluting, or repackaging biological products subject to licensure under section 351 of the PHS Act, because none of the products produced at the facility would qualify for the exemptions provided in section 503B.”

Remember, outsourcing facilities need to pay a yearly fee to register.  Be certain of your status and proceed with caution because the wrong decision can result in forfeiture of any fee paid (they are non-refundable) and you will be required to meet cGMPs and be subject to FDA inspection.