New Guidance Issued by the FDA Provides Clarity on Whether Non-Sterile Compounders Can Register as Outsourcing Facilities

February 13, 2015 was certainly “Friday the Thirteenth” type of day within the Food and Drug and Administration (FDA), with the Agencies publishing five draft guidances and policies regarding pharmacy compounding. Among the guidances and documents published included a Draft Guidance intended for entities considering whether to register with the FDA as an Outsourcing Facility under Section 503B of the Food, Drug, and Cosmetic Act. In 2013, Congress passed a law (the Drug Quality and Security Act of 2013) which created a new class of compounders: Outsourcing Facilities. Since that time, the FDA has indicated it has received 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. 

In its Guidance for Industry entitled “For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act,” the FDA first clarified the definition of an Outsourcing Facility as:

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.

See, 21 U.S.C. § 353b(d)(4). The FDA further clarified that Section an Outsourcing Facility is not required to be a licensed pharmacy, and may or may not obtain prescriptions for identified individual patients. Finally, the Draft Guidance reiterated the requirements for which a drug product compounded by an Outsourcing Facility would qualify for exceptions for “new drug” requirements and labeling requirements. With that in mind, the FDA provided additional guidance as to what sorts of entities should or should not register as Outsourcing Facilities, and what impact such registration would have.

First, the FDA clarified that because the definition of “Outsourcing Facility” was a facility engaged in the compounding of sterile drugs, a pharmacy that performed no sterile compounding should not register as an Outsourcing Facility. However, the FDA did clarify that if a facility compounds sterile human drugs and otherwise meets the definition of an Outsourcing Facility (i.e., registration, compliance, etc.), any non-sterile human drugs compounded by the facility would also be eligible for the exemptions from the “new drug” requirements and labeling requirements, so long as those non-sterile drugs were compounded in accordance with the requirements of Section 503B, including the cGMP requirements.

Second, the FDA clarified that a facility should not register as an Outsourcing Facility if the only activities conducted at the facility are repackaging, or mixing, diluting, or repackaging biological products subject to licensure under section 351 of the Public Health Service Act. However, the FDA went on to state that, if a facility that meets the definition of an Outsourcing Facility repackages certain human drugs, or mixes, dilutes, or repackages biological products outside the scope of an approved biologics license application (BLA), the FDA does not intend to take action against those products for violations of certain provisions of the Food, Drug & Cosmetics Act or the PHS Act, provided those products satisfy the conditions described in the two separate guidances also issued by the FDA on February 13, 2015. In short, those guidances provide enforcement discretion by the FDA for state-licensed pharmacies or Outsouricng Facilities repackage certain drug products, notwithstanding the fact that they might be in violation of law.

Also of note, the FDA provided that drugs compounded at an Outsourcing Facility are not eligible for the exemptions provided in Section 503A, even if the conditions in that section are met with respect to the particular drug. Therefore, this new guidance provides some clarity for compounding pharmacies currently operating as tradition, Section 503A pharmacies. If a Section 503A is interested in seeking the benefits of unrestricted interstate shipment of compounded products, they may only properly register as an Outsourcing Facility if they perform sterile compounding, and if they otherwise comply the all of the Section 503B requirements with respect to all products.

In all, compounding pharmacies need to be prepared and well-counseled for the new environment. Frier Levitt attorneys have spent hours reviewing the new laws and guidances, as well as communicating with the FDA. As such, Frier Levitt has unique insight into the FDA to foresee likely forms of FDA enforcement and regulations. Contact us today for assistance in preparing your pharmacy for the implementation of these requirements and adapting your business to comply with the laws and regulations going forward.