FDA guidance intended to help compounders decide whether to register as outsourcing facilities may ultimately push some to exit the list.

The draft guidance, issued Feb. 13 along with several other compounding documents, is intended to answer questions about whether compounders conducting certain activities should register.

But while FDA indicates which activities it believes should warrant registration, it also gives examples of compounders that should not register. And even though outsourcer user fees will not be refunded, it may push some pharmacies to give up their outsourcer status – and with it direct FDA oversight.

The agency suggested entities considering outsourcer registration “to first review all relevant and related guidance issued by the agency and decide whether their products may qualify for the exemptions provided,” according to guidance questions and answers posted on its website.

New Compounding Documents and Resources

“FDA wants facilities to understand that registration under section 503B of the FD&C Act is only one condition for drugs compounded by an entity to be exempt from the new drug and adequate directions for use provisions under section 503B,” the agency said in an email to “The Pink Sheet” DAILY.

“If the other conditions in that section are not met, then the registered facility will have paid an annual establishment fee even though it’s compounded drugs will not be eligible for the exemptions provided under section 503B.”

A perceived attempt to prune the list may surprise some stakeholders, especially after FDA asked hospitals, states and others to encourage compounders to register ([A#14140110003]).

Registered outsourcers were created in the 2013 Drug Quality and Security Act as part of the agency’s enhanced oversight of compounding. Facilities that register must pay a user fee, submit to regular FDA inspections and follow Good Manufacturing Practices.

The agency listed 48 outsourcing facilities on its website as of Feb. 12.

Outsourcing establishment fees were set at $16,442 for FY 2015 ([A#00140804007]).

Outsourcers Subject To GMP For All Products

The agency said in the guidance that registration represents intent by the facility for its compounded drugs to be governed by the new compounding regulations.

FDA wrote that if a facility does not “intend to compound all drugs” in compliance with GMP and DQSA requirements, “you should not register as an outsourcing facility.”

The agency also said in the guidance that a facility must compound sterile human drugs to meet the outsourcer definition. Compounding also does not include repackaging, and the definition of drugs in this case does not include certain biologics and animal drugs, according to the draft guidance.

FDA went on to make it plain that facilities only repackaging, mixing or performing a combination of those or other functions should not register.

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

The agency also wrote that products compounded at an outsourcing facility are not eligible for the exemptions in section 503A, which governs traditional compounders, “even if the conditions in that section are met with respect to the particular drug.”

The outsourcing facility designation was intended in part to allow FDA oversight over large-scale compounders, but it is a voluntary designation.

Traditional compounders continue to be overseen by their state boards of pharmacy.

When the law passed, a number of facilities were expected to register because it would allow access to the office-use market for compounded medications ([A#14131118004]).

FDA interprets DQSA to mean that only outsourcers can compound without receiving an individual prescription, but there are conflicting state laws ([A#14140519005]).

FDA also said in the guidance that outsourcing facilities compounding non-sterile human drugs in addition to sterile human drugs may be eligible for the exemptions afforded in the law.

But the agency also said if an outsourcing facility “repackages certain human drugs, or mixes, dilutes or repackages biological products outside the scope of an approved BLA, FDA does not intend to take action against those products” for violating the Food, Drug and Cosmetic or Public Health Service acts, provided they follow the associated guidances.

AE Reporting, Repacking Guidances Also Issued

Among the other new compounding documents issued was a draft memorandum of understanding with FDA that states could sign to set responsibilities when complaints emerge about compounded drugs being shipped across state lines.

Pharmacists are limited in the amount of compounded drugs they may ship across state lines in states that do not sign a memorandum of understanding ([A#00131209010]).

FDA also issued a draft guidance on adverse event reporting standards for outsourcing facilities and repackaging issues for drugs and biologics.

In addition, the agency recently restarted its Pharmacy Compounding Advisory Committee, which will meet Feb. 23-24 to begin its review of bulk substances that may be compounded and products that should not be compounded ([A#14150123003]).

[Editor’s note: This story has been updated to reflect the proper citation for the statutory provisions mentioned.]

FDA Compounding Guidances Might Cull Outsourcing List

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