Since the newsletter came out on Monday instead of Friday last week (due to vacations, etc.), we will repeat some of the items in that newsletter as they are important. (We know how busy Mondays and the day before a holiday can be and oftentimes important emails may be overlooked.)

1. SOP FOR EVALUATING HUMAN-USE STERILIZING FILTERS

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 available to subscribers on the www.CompoundingToday.com website. The document is titled

"SOP No. 6.097 Filter Qualification/Evaluation Procedure"

2. WHITE PAPER: HUMAN-USE STERILIZING FILTER ISSUE

Don't forget, you can download free all the responses received from various filter companies during the entire process on the www.CompoundingToday.com website. The updated documentation is titled

"White Paper: Human-Use Sterilizing Filter Issue"

3. NEW USP STATEMENT CLARIFIES RESPONSIBILITY

The USP website now has posted a new presentation "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." Later in the document it states "USP provides both general chapters and monographs for compounded preparations." The general chapters related to quality of ingredients and compounded preparations, including strength, sterility, analytical methods used, etc., do apply. Please take time to read this document.

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

4. 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 1,100 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/

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

News

FDA Refuses to Comply with DQSA
Recently, several 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.

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

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Did You Know ...

...that an important consideration related to state boards of pharmacy adopting USP chapters (e.g., <800>) by reference vs writing their own is a matter of CONTROL?

Tip of the Week

State boards of pharmacy writing their own practice standard regulations MAINTAIN CONTROL and can easily modify, update, etc. based upon their individual state characteristics and situations.

Adopting the USP practice standards by "reference" is delegating the responsibility from the state to USP and is a LOSS OF CONTROL by the individual state board. Historically, USP is extremely slow in modifying standards. This is more efficiently and practically accomplished at the state level.

Looking Back

Ring out the old,
Ring in the new,
What good can,
Shaving brushes do?
     Burma Shave