USP <797> Pharmaceutical Compounding—Sterile Preparations first became official January 1, 2004. It was revised, and the new revision of <797> became official on June 1, 2008. With each revision, there is "something old, something new, something borrowed, something blue!" to use an expression. Some of the changes have been good and others have been problematic.

The 2nd revision of <797> has now progressed to the review and comment stage, and this is a very critical stage as it is the opportunity for practitioners to review the proposed draft and make comment(s) on what may be problematic once it is official and becomes the "standard of the land." Often I am asked, "How can I let them know the impact of the standards on my practice and what works and what doesn't work"? Well, this is the time and here is a suggestion on how to do it.

1. Download a copy of the chapter at:
   www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision.
2. PRINT a copy of the chapter.
3. Remove pages 2-84: these are the strikeout pages consisting of the old text (that is currently official and can be referred to for comparison of text).
4. Place page 1 (Briefing) on top of pages 85-143.
5. This is now your working document.
6. Read it slowly and thoroughly the first time and write down your impressions on the pages.
7. Read it the second time slowly and thoroughly and compare the text with your current practice and determine what changes you may need to make and to see if anything is missing that should be present.
8. Read it the third time slowly and thoroughly and make additional notes and review them in light of what is scientifically valid and practical.
9. At the end of page 1 Briefing, there is a link to a submission template form. Download this form and use it for making comments.

   Specific Comments:

   Section(s)	Line Number(s)	Existing text: (Provide the proposed text.)	Suggested change: (Provide the revised suggestion to replace the existing text.)	Comment	Rationale / Scientific Evidence

10. Add your comments according to the line headers above.
11. In the last column, even though there is no rationale/scientific evidence presented in the comment draft, it is requested in these comments.
12. Submit the form by email to CompoundingSL@usp.org for the Pharmacy Compounding Expert Committee to review, evaluate, and determine what changes should be made.
13. Sit back, relax, and feel good that you have done your part!

Remember, if you don't participate, don't gripe and complain later! It's all up to you!

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 to Destroy Banned Imported Drugs
The FDA will begin destroying some medications that can't be imported into the U.S. because of quality concerns. Starting on October 15, they will destroy a drug that wasn't allowed into the U.S. because it's been found to have been "adulterated, misbranded or unapproved" and in violation of the Food, Drug and Cosmetic Act. "This new rule allows FDA to better deter such importation by having an administrative process in place to destroy a refused drug," the FDA says. About 40% of the drugs taken by Americans are imported, with nearly 80% of the active ingredients in the U.S.-sold drugs coming from overseas. The FDA has been concerned about the global proliferation of counterfeit drugs that carry labels to look like actual brand-name prescription medications but contain ingredients that in some cases are harmful.
http://www.modernhealthcare.com/article/20150930/NEWS/150939991/fda-will-destroy-banned-imported-drugs

503b Facility Recall of Sterile Compounded Preparations—Lack of Sterility Assurance
US Compounding, Inc. is voluntarily recalling all lots of sterile preparations aseptically compounded and packaged by USC and that remain within expiry due to the FDA's concern over a lack of sterility assurance. These preparations were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. The recall does not pertain to any nonsterile compounded medications prepared by USC.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlerts
forHumanMedicalProducts/ucm464086.htm

South Carolina Pharmacists Indicted for Funneling Rx Records to Attorneys
Two South Carolina pharmacists have been indicted for allegedly providing confidential prescription records from the state's database to aid attorneys in court cases. Pharmacists Timothy Keisler and Robert Bennett are both charged with misusing the state's prescription drug database. Keisler, 49, co-owns Preferred Care Pharmaceutical Services in Hollywood, South Carolina; he is accused of retrieving prescription records and providing those records to Bennett, 57, who operates Medical-Legal Services in West Ashley, South Carolina. Bennett is accused of subsequently sharing those records with attorneys.
http://drugtopics.modernmedicine.com/drug-topics/news/pharmacist-accused-funneling-rx-records-attorneys

2013 Price Report Published by IFHP
The International Federation of Health Plans (IFHP) today released its 2013 Comparative Price Report. The survey shows pricing for five specialty prescription drugs and shows, as in prior years, that the U.S. continues to have the highest prices of those countries surveyed for drugs and various medical procedures. For example, the price for the cancer drug Gleevec ranged from $989 in New Zealand to $6,214, the average price paid in the U.S.; also, Copaxone ranged from $862 in England to $3,903 in the U.S.
http://www.ifhp.com/1404121

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Did You Know ...

�that the squeaky wheel gets the grease?

Tip of the Week

It's your profession. If you don't participate in organizational, political, regulatory, standards-setting activities, you are giving up ownership to others that do. Yes, it takes time�but not as much time and money as you spend complying with and complaining about it later!

Looking Back

A whiskery kiss,
For the one you adore.
May not make her mad,
But her face will be sore!
     Burma Shave

Classifieds

Agents Wanted
503B and Sterile drug manufacturing facility CGMP compliant seeks "sales and service" contract agents for drug sales into the Compounding Drug Market. Unique opportunity
Contact: Gary Hanley, CEO Asept Pak/SterRx, 518 353 3210
admin@aseptpak.com