FDA Offers Three Guidances on Drug Compounding

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April 18 — The FDA recently released three drug compounding draft guidances on prescription requirements, hospital and health system compounding and the definition of a facility.

Notices announcing the draft guidances were published in the April 18 Federal Register (81 Fed. Reg. 22,610; 22,611; 22,617). Comments on the draft guidances are due July 18.

The Food and Drug Administration said the draft guidances apply to both outsourcing facilities and drug compounders. The Drug Quality and Security Act (DQSA) (Pub. L. No. 113-54), which was signed into law in November 2013 (11 PLIR 1438, 12/6/13), distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs and those compounders making large volumes of compounded drugs without individual prescriptions. Compounders outside the scope of traditional pharmacy practice can voluntarily register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers.

The draft guidances describe FDA’s proposed policies concerning: the prescription requirement in section 503A of the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended by the DQSA; how the agency intends to apply the prescription requirement in section 503A to drug compounding in a hospital or health system pharmacy; and the definition of the term “facility” in section 503B of the FD&C Act, the agency said.

Section 503A describes the requirements for traditional compounding pharmacies and Section 503B describes the requirements for outsourcing facilities.

Draft Guidances

The three draft guidances are:


The FDA said the first guidance explains its policies concerning prescription requirements for compounding human drug products for identified individual patients under section 503A. “It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use,” the agency said.

Elizabeth Jungman, director of public health at the Pew Charitable Trusts, told Bloomberg BNA in an April 18 e-mail that “prescription defines the line between traditional pharmacy compounding and these larger operations” and “the guidance will give the compounding industry much needed clarity.”

“The guidance will give the compounding industry much needed clarity.”

The second guidance describes how the FDA intends to apply section 503A to drugs compounded in state-licensed hospital or health system pharmacies for use within the hospital or health system, the agency said. Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drugs for administration within the hospital or health system. Some of these compounders have registered with the FDA as outsourcing facilities under section 503B and others are state-licensed pharmacies subject to section 503A.

Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address,” the FDA said.

The last guidance “seeks to answer questions received from outsourcing facilities and other stakeholders about the meaning of the term ‘facility,' such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards,” the agency said.

Pharmacies `Disappointed' by Draft

John Voliva, executive vice president of the International Academy of Compounding Pharmacists (IACP), said in an April 18 statement provided to Bloomberg BNA that “IACP is disappointed, once again, that the FDA is ignoring Congressional intent in regards to office-use compounding with the publication of these drafts.”

“While we are still reviewing all three documents, it is clear the FDA believes that non-hospital owned 503A pharmacies cannot participate in office-use compounding while in the same breath, allowing hospital-owned pharmacies (which are still under the jurisdiction of 503A) to participate in office-use compounding as long as certain restrictions are met,” Voliva said.

“Statutorily, this makes absolutely no sense—how can one ‘type' of 503A pharmacy perform office-use while another may not? In addition, FDA’s draft guidance on anticipatory compounding is confusing at best and may ignore the clear language of bill when it comes to defining this practice.”

Voliva said that once the IACP more thoroughly reviews the proposed guidances, it “will engage the agency in the commenting process.”

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

For More Information

The guidance on prescription requirements is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496286.pdf.

The guidance on hospital compounding is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496287.pdf.

The guidance on the definition of “facility” is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM496288.pdf.

The Federal Register notice on the prescription requirements guidance is at https://www.gpo.gov/fdsys/pkg/FR-2016-04-18/pdf/2016-08877.pdf. The notice on the hospital compounding guidance is at https://www.gpo.gov/fdsys/pkg/FR-2016-04-18/pdf/2016-08879.pdf and the notice on the facility definition guidance is at https://www.gpo.gov/fdsys/pkg/FR-2016-04-18/pdf/2016-08878.pdf.

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