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Editorial: FDA and the Advisory Committee on Compounding

The provisions of Section 503A require rulemaking or other action by the FDA. Some of these actions require decisions regarding the following.

Formation of the Advisory Committee on Compounding:

The law (HR 3204) states:

"Before issuing regulations to implement subsection (a)(6), the Secretary shall convene and consult an advisory committee on compounding. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations." (See below)

The FDA, in consultation with the Advisory Committee on Compounding, will make decisions regarding the following.

1. The "Negative List"
The first committee developed and approved a "negative" list consisting of drugs which have been removed for safety reasons. The new committee will be involved in recommending a final rule which lists drug products that may not be compounded because they have been withdrawn or removed from the market because they have been found to be unsafe or not effective.

2. The "Positive List of APIs"
This activity will look at bulk drug substances that (1) do not contain a USP or NF monograph, (2) are not components of FDA-approved drug products, or (3) do not contain a monograph in another compendium or pharmacopeia recognized by the Secretary.

3. Demonstrable Difficulties in Compounding
A list of drug products that present demonstrable difficulties for compounding is to be developed. This will be drug products that present demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of the drug product.

Next week, we will look at some "definitions" in HR 3204.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

FDA Request for Nominations
Sections 503A and 503B require the creation of and consultation with a Pharmacy Compounding Advisory Committee before issuance of certain regulations required by the law. The FDA has published in the Federal Register notices soliciting nominations for Committee members. The following websites contain information regarding nominations for the Pharmacy Compounding Advisory Committee.
https://www.federalregister.gov/articles/2014/01/13/2014-00319/request-for-nominations-for-a-voting-consumer-representative-on-the-pharmacy-compounding-advisory

https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-00318.pdf

https://s3.amazonaws.com/public-inspection.federalregister.gov/2014-00320.pdf

IV Fluids Shortage and the FDA
The FDA is addressing a shortage of IV solutions, especially 0.9% Sodium Chloride Injection. It is working with Baxter, B. Braun, and Hospira to help preserve the supply of these products. Baxter reported their products are on allocation, and they are working to increase availability; Hospira has announced that their shortage is due to manufacturing delays.
http://www.empr.com/fda-addresses-iv-fluids-shortage/article/330207/

Dermatitis Due to Zinc Deficiency Resulting from a Nationwide Shortage of Injectable Zinc
Zinc injection, a vital component of parenteral nutrition formulations, has been in short supply since late 2012. In December 2012, three premature infants with cholestasis who were hospitalized in Washington, DC, experienced erosive dermatitis in the diaper area and blisters on their extremities, a condition that can be associated with zinc deficiency.
http://www.cdc.gov/mmwr/pdf/wk/mm6302.pdf

Roche Resolves Shortage of Liquid Tamiflu
Tamiflu Oral Suspension is now available, resolving the temporary shortage of a few weeks ago. Roche stated that it should remain available for the remainder of the flu season. Roche also reported that there has been a continuous supply of Tamiflu 75-mg capsules throughout the 2013-2014 flu season.
http://www.fiercepharma.com/story/roche-resolves-shortage-liquid-tamiflu/2014-01-16

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Even though we joke about politics a lot, it is serious business! Get informed, as we have an important election coming up this fall!

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PCAB is proud to announce the accreditation of the following pharmacy:

Pensacola Apothecary, Pensacola, Florida; Andrea Bourgoin, PharmD, andrea@apothecaryrx.com. Re-accreditation for Sterile & Nonsterile Compounding