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Bloomberg BNA: FDA Advisory Panel Votes Against Compounding Certain Drugs
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Reproduced with permission from Pharmaceutical Law & Industry Report, 14 PLIR 373 (March 11, 2016). Copyright 2016 by The Bureau of National Affairs, Inc. (800-372-1033)  


Pharmacy Compounding Advisory Committee

Takeaway: The panel votes against including five substances on the list of ones that may be compounded, gives mixed votes to a lupus treatment and says metered dose inhalers and dry powder inhalers are difficult to compound.

Reaction: A compounding pharmacist group said it was disappointed with the committee's votes because patients who rely on these compounded medications will be hurt.

By Bronwyn Mixter

March 9 -- An FDA advisory panel recently rejected certain drugs for inclusion on a list of substances that can be compounded, and a pharmacy group said the panel's decision would limit patient access to these medications.

The Food and Drug Administration's Pharmacy Compounding Advisory Committee (PCAC) voted against including five bulk drug substances on the list, gave mixed votes to a lupus treatment and voted to recommend that some inhalers be put on a list of products that are difficult to compound.

On March 8, the committee voted overwhelmingly against recommending that these bulk drug substances be included on the list of substances that may be compounded under the exemptions provided by Section 503A of the Federal Food, Drug, and Cosmetic Act:

• boswellia, used to manage inflammatory disorders;
• aloe vera 200:1 freeze dried, used to treat certain skin conditions;
• D-ribose, used to treat coronary artery disease and other conditions;
• chondroitin sulfate, used to treat arthritis; and
• acetyl-L-carnitine, used to improve memory and for other conditions.


Section 503A governs traditional compounding facilities.

The PCAC also gave mixed votes on quinacrine hydrochloride, a drug used to treat lupus that isn't commercially available in the U.S. Five panel members voted that it shouldn't be put on the list of drugs that can be compounded and six panel members voted that it should be on that list, an FDA spokeswoman told Bloomberg BNA March 9.

On March 9, the PCAC also voted to recommend that metered dose inhalers and dry powder inhalers be put on the list of drug products that present demonstrable difficulties in accordance with Sections 503A and 503B of the FDCA, the spokeswoman said. Section 503B governs outsourcing facilities.

The Drug Quality and Security Act (Pub. L. No. 113-54), which was signed into law in November 2013, distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs from those 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.

That law responds to a deadly outbreak of meningitis from compounded, or custom-made, drugs from a pharmacy in Massachusetts in the fall of 2012.

The FDA will take the committee's recommendations under consideration as it makes its final decision on these drug substances.

Pharmacist Reaction.

Gary McCrory, president of the International Academy of Compounding Pharmacists, told Bloomberg BNA in a March 9 e-mail that the IACP was disappointed with how the committee voted.

“Patient access to these compounded medications upon which they rely is of paramount importance” to the IACP, McCrory said. “From a practicing pharmacist’s perspective, our utmost concern is taking care of our patients. With the inability to use some of these bulk drug substances, patients will be negatively impacted.”

McCrory said that while the IACP was encouraged that the FDA established the PCAC, the IACP “never has been confident with the process FDA used to assemble the current panel.”

“IACP continues to have serious concerns about the lack of representation of actual practicing compounding pharmacists,” McCrory said. “IACP submitted 24 nominees to the FDA, many with extensive real-life compounding practice experience, and only one was selected. Further, the compounding pharmacist we nominated and accepted was not granted the ability to vote by FDA. The FDA deemed this pharmacist a non-voting member of the panel.”

McCrory said the IACP isn't confident that “compounding pharmacists have a real seat at the PCAC table, and we have continuing concerns that the Drug Quality and Security Act (DQSA) will not be implemented as Congress intended.”

By Bronwyn Mixter

To contact the reporter on this story: Bronwyn Mixter in Washington at

To contact the editor responsible for this story: Lee Barnes at

More information about the advisory committee meeting is available at

Copyright 2016, The Bureau of National Affairs, Inc.

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