Editorial: USP Chapter <797> Question of the Week

If I add a preservative to a compounded sterile preparation, can I extend its beyond-use-date?

The beyond-use-dates for sterile preparations are divided into two categories. If a program of sterility testing IS NOT in place, then the short beyond-use dates described in USP Chapter <797> for the different risk levels are to be used. If a program of sterility testing IS in place, then the beyond-use dates described in USP <795> for different types of preparations/formulations can be used, which are somewhat longer than those in USP <797>.

Beyond-use dates are established based upon chemical and physical stability aspects of a compounded preparation, not on whether or not it is microbiologically preserved. If a sterility testing program is in place, then each compounded preparation is considered "sterile," then the area of concern is that of chemical and physical stability. In manufacturing, every dosage unit is not tested, just a sample. In compounding, not every preparation is tested, just a sample. A sterility testing program must be in place to demonstrate that the compounding procedures are under control. A very generalized statement can be made that the difference between USP <795> and USP <797> is the requirement for sterility. The majority of USP <797> is involved with the requirements necessary to achieve and maintain sterile compounded preparations and the chapter includes the required standards of the facility, equipment, personnel, training, etc.

In summary, microbiological preservatives cannot be used to extend the chemical stability of a compounded sterile preparation. Rather, a program of sterility testing and then appropriate additional specific stability studies of a compounded preparation should be considered if a longer beyond-use date is needed.


Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief

*Auralgan otic solution has now been reformulated so that it is different from its generic counterparts. The original formula consisted of antipyrine and benzocaine, but the revised formula has acetic acid and U-polycosanol 410 added to the formula. The currently available generics are the original formula. The new revised Auralgan costs about $140 per bottle compared to the generic of only about $2. The Pharmacist's Letter has available a "form letter" to apprise physicians of the change and for the clarification of whether they want the original Auralgan, which is only available as a generic, dispensed or the new Auralgan, which is only available as the brand name product at a much higher price. Pharmacist's Letter May 2008; 24(5).

*Concern increases over drug and food products from overseas. The heparin situation is another occurrence following in the tracks of the melamine problem where melamine was added to pet food to fake higher protein levels and the earlier use of diethylene glycol in some cough syrups instead of glycerin. The FDA is announcing that they are instituting a new program called "FDA Beyond Our Borders," and it will start in China. Pharmacist's Letter May 2008; 24(5). Editors Note: Maybe it would be best if we did whatever was necessary to bring manufacturing processes back into the U.S.

*Pharmaceutical companies are not doing the studies they promised they would do if the FDA would approve their products. As of September 30, 2008, 1,044 post-market drug studies had not been conducted even though the companies pledged to the FDA that they would perform them; some of these date back to October 2004. FDLI SmartBrief April 24, 2008 http://www.bloomberg.com/apps/news?pid=20601202&sid=acu6znqklhBo&refer=healthcare

*Congress is looking at proposed legislation that would require all labels on food, drugs, and medical devices to include their country of origin. This would include the origin of active ingredients and the place of manufacture. http://www.washingtonpost.com/wp-dyn/content/article/2008/04/17/AR2008041703088.html

*"Shocking recent disclosures about Merck's widespread ghost-writer reports—with payments to prestigious healthcare providers—vividly demonstrate the audacity of pharmaceutical drug company monetary influence," states the Connecticut Attorney General. He is calling for a ban on drug company gifts and other benefits provided to doctors that may improperly influence healthcare decisions. http://pharmalive.com/news/index.cfm?articleID=533640&categoryid=9&newsletter=1

USP Workshop #3 on USP Chapter <797> Pharmacy Compounding—Sterile Preparations will be held on May 22 and 23, 2008, at the USP headquarters in Rockville, Maryland (Washington, DC). Attendance is growing at each of these "hands-on" workshops. The next workshop is filling up fast. Go to: http://www.usp.org/hottopics/generalChapter797.html?hlc, or contact Dr. Claudia Okeke at 301-816-8243 to register.

The BHRT World Summit is presenting an Internet Audio Seminar intended for doctors and pharmacists to send to their patients/customers to increase the awareness of BHRT and its many manifestations.

Speakers include Doctors Erika Schwartz, Eldred Taylor, Susan Silberstein, Jeanne Drisko, Ellie Campbell, Rebecca Glaser, Allan Magaziner, Andrew Jones, and Richard Shames, along with Pharmacist David Nicoletti.

During the seminar, we will take advantage of the vast number of people listening (projected 50,000 listeners) to work on the grassroots campaign to fight for our rights to treat patients with compounded hormones.

Please see the website: http://www.bhrt1.com

Note: Gallipot was inadvertently omitted from last week's resource directory which featured air sampling devices. Please add Gallipot to your list of providers. Thank you.

IJPC strongly urges you to support our current advertisers and supporters. Next week's newsletter will feature Endotoxin Testing Device Kits.

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According to the nonpartisan Center for Responsive Politics, trade associations, corporations, labor unions, and other interest groups spent $2.79 billion last year trying to influence Congress and federal agencies. The leader in spending was the pharmaceuticals/health products industry which spent $227 million during the first session of the 110th congress. Its reported lobbying efforts increased 24% in 2007. Big spenders include PHARMA ($22.7 million), AMA ($22.1 million), AHA ($19.7 million), AARP ($19.5 million), Amgen ($16.3 million), Pfizer ($13.8 million), Medco ($2.0 million), CVS/Caremark ($1.7 million), and Express Scripts ($980,000). http://www.opensecrets.org/lobbyists/overview.asp?showyear=2007&txtindextype=i

Video Education
Use the following video as a great educational tool in your pharmacy, exhibits, and shows. Can you name all the parts and the processes occurring in this awesome animation about "The Cell"? A little review of your college course notes may be required! http://aimediaserver.com/studiodaily/harvard/harvard.swf