In the Newsletter on June 16, we presented a reasonable approach involving verifying standards for filters used to sterilize drug preparations for human use and comparing them with the documents (Certificates of Analysis or other documentation) from the filter companies.

In order to accommodate this activity, there is a new Standard Operating Procedure, SOP No. 6.097 Filter Qualification/Evaluation Procedure available to subscribers on the www.CompoundingToday.comwebsite.

Also, don't forget, you can download free the updated documentation "White Paper: Human-Use Sterilizing Filter Issue," which includes all the responses received from various filter companies during the entire process at the same website.

The USP website now has a new presentation of "USP in U.S. Law" and appears to clarify their responsibility, discussing ingredients and products and not professional standards. It states that the USP develops standards for "Medicines, Food Ingredients, and Dietary Supplements." Under "Medicines," specific drug categories and topics include "Drugs, Biologics, Medical Devices, Compounded Preparations and Nomenclature." Please take time to read this document.

http://www.usp.org/about-usp/legal-recognition/usp-us-law

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

Announcement

Dr. Maria Carvalho is offering her PhD dissertation as a free download; it is titled "Extemporaneously Compounded Oral Medicines in European Hospital Pharmacies" It has over 1,000 downloads so far and is excellent reading and a current resource on compounding in European hospitals. It is highly recommended. It can be downloaded at:

http://discovery.ucl.ac.uk/1396480/

News

Compounding Pharmacists to Solve the Sodium Bicarbonate Shortage?
Sodium bicarbonate is becoming increasingly difficult for emergency rooms to obtain. This potentially creates problems since few alternatives are available; one of the alternatives, sodium acetate, is also facing a shortage.

As stocks continue to be depleted, pharmacists could be the ones addressing the shortage.
http://drugtopics.modernmedicine.com/drug-topics/news/could-compounding-pharmacists-solve-sodium-bicarbonate-shortage

[Editor's note: One problem is this is considered "office-use compounding"---read on! It doesn't appear the FDA is concerned with patients!]

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Did You Know ...

�that recently pharmacy organizations provided comments to the FDA on compounding? They called for FDA to:

• issue a MOU that addresses the "distribution" of compounded products over state lines;
• issue a final guidance allowing pharmacists to compound for "office use" "in anticipation of receiving patient-specific prescriptions at a later time;" and
• provide a reminder to FDA that pharmacies that compound under 503A are under the purview of state boards of pharmacy and are not to be held to CGMPs.

Tip of the Week

FDA responded that:

• it still plans to continue to include "dispense" in the definition of "distribute" in a new MOU, and
• it believes the agency is aligned with congressional intent by issuing final 503A guidance prohibiting office use, despite existing federal law and congressional correspondence allowing the practice.

The FDA also stated it only takes one medication without a prescription during an inspection at a pharmacy compounding under 503A for inspectors to cite CGMPs on a Form FDA-483.

http://www.pharmacist.com/article/apha-submits-compounding-comments-fda

Looking Back

Soap may do,
For lads with fuzz.
But sir, you ain't,
The kid you wuz!
     Burma Shave