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  1. Guidance, Compliance, & Regulatory Information

Questions and Answers Related to Guidance for Entities Considering Whether to Register As Outsourcing Facilities

Questions and Answers Related to Guidance for Entities Considering Whether to Register As Outsourcing Facilities

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See Guidance For Entities Considering Whether to Register As Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act for more information.

What types of facilities should register with FDA as an outsourcing facility?

The guidance states that only facilities that intend, upon registration, to comply with all of the provisions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), meet current good manufacturing practice (CGMP) requirements, and engage in the compounding of sterile human drug products should register as an outsourcing facility. If a facility does not register as an outsourcing facility, engage in the compounding of sterile human drugs and/or does not comply with all of the provisions of section 503B, the facility does not meet the definition of an outsourcing facility in section 503B.

Furthermore, the guidance states that drugs compounded by the facility can only qualify for the statutory exemptions described in section 503B from the new drug approval requirements, the requirement to be labeled with adequate directions for use, and the supply chain security requirements of the FD&C Act if all of the facility’s compounded drugs are compounded in accordance with section 503B. See FDA’s guidance document on this subject for more information.

If a facility engages ONLY in one or more of the following activities, should it register with FDA as an outsourcing facility?

  • Repackaging human drugs
  • Mixing, diluting, or repackaging biological products subject to licensure under section 351 of the Public Health Service Act (PHS Act) [i.e., subject to approval in a biologics license application (BLA)]
  • Compounding non-sterile drugs
  • Compounding animal drugs

The guidance states that a facility that engages in only these activities, or engages only in a combination of these activities, should not register as an outsourcing facility because the drugs it produces will not be eligible for the statutory exemptions described in section 503B of the FD&C Act.

If the facility engages in either of the following activities, should it register with FDA as an outsourcing facility?

  • Compounding sterile human drugs
  • Compounding sterile and non-sterile human drugs

The guidance states that a facility that engages in these activities could register as an outsourcing facility and its drugs could qualify for the exemptions applicable to outsourcing facilities. In particular, the guidance states that an outsourcing facility can compound non-sterile human drugs provided that it also compounds sterile human drugs.

If the facility engages in either of the following activities, should it register with FDA as an outsourcing facility?

  • Compounding sterile human drugs and repackaging human drugs
  • Compounding sterile human drugs and mixing, diluting, or repackaging biological products subject to approval in a BLA

FDA’s final guidance documents state that a facility that repackages human drug products, or that mixes, dilutes, or repackages biological products subject to an approval in a BLA, should only consider registering as an outsourcing facility if it also compounds sterile human drugs, meets GGMP requirements, and meets all of the conditions in section 503B. FDA does not intend to take action against an outsourcing facility that repackages human drug products, or mixes, dilutes or repackages certain biological products outside the scope of an approved BLA, for violations of specified provisions of the FD&C Act and the PHS Act, as applicable, if all of the conditions described in the guidance documents are met.

If a facility is registered as an outsourcing facility and compounds drugs pursuant to patient-specific prescriptions, can those drugs qualify for exemptions under section 503A of the FD&C Act?

Under section 503B of the FD&C Act, an outsourcing facility may or may not obtain patient-specific prescriptions for its compounded drugs. The guidance states that by registering as an outsourcing facility, the entity is electing to have its compounded drugs regulated under section 503B, not section 503A. The guidance further states that drugs compounded at an outsourcing facility are not eligible for the exemptions provided in section 503A, even if the conditions in that section, such as compounding pursuant to patient-specific prescriptions, are met with respect to the particular drug.

If a facility registers with FDA as an outsourcing facility and later de-registers, would the facility receive a refund for the fees it has already paid?

Section 744K of the FD&C Act makes no provision for the refund of fees associated with registration and re-inspection of outsourcing facilities. Therefore, FDA has determined that fees paid pursuant to sections 503B and 744K of the FD&C Act will not be refunded, even if an entity that has registered as an outsourcing facility subsequently withdraws its registration as an outsourcing facility.

FDA encourages all entities that are considering registering as an outsourcing facility under section 503B of the FD&C Act to first review all relevant and related guidance issued by the agency and decide whether, if they register, their products could qualify for the exemptions provided under section 503B.

How does an outsourcing facility qualify for a small business reduction in the annual establishment fee?

An entity with gross annual sales totaling $1,000,000 or less in the 12 months ending on April 1 of the fiscal year immediately preceding the fiscal year in which the annual establishment fee is assessed may qualify for a small business reduction.

Entities that seek a small business reduction of the annual establishment fee must make a request for such a reduction by April 30 of the year preceding the fiscal year for which the entity is seeking a reduced fee.

For more information concerning small business reductions, including the content and format of the request to the agency for a reduction, see FDA’s guidance, Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.