This week, let's "dig down" into the organization of the Compliance Policy Guidelines (CPG) manual.

The CPG Manual is organized as:

• Chapter 1 General
• Chapter 2 Biologics
• Chapter 3 Devices
• Chapter 4 Human Drugs
• Chapter 5 Food, Colors, and Cosmetics
• Chapter 6 Veterinary Medicine

Chapter 4 involving Human Drugs is further divided into the following "Subchapters":

• 400 General
• 410 Bulk Drugs
• 420 Compendial/Test Requirements
• 425 Computerized Drug Processing
• 430 Labeling and Repackaging
• 440-448 New Drugs
• 450-457 OTC
• 460 Pharmacy Issues
• 470 Post Approval Issues
• 480 Stability/Expiration
• 490 Validation

Subchapter 460 Pharmacy Issues is further divided into the following "Sections""

• 460.100 Hospital Pharmacies-Status as Drug Manufacturer
• 460.200 Pharmacy Compounding
• 460.300 Return of Unused Prescription Drugs to Pharmacy Stock
• 460.400 Computerized Prescription Recordkeeping by Pharmacies
• 460.425 Prescription Status when Telephoned to Recording Machine
• 460.450 Status of Mail-Order Filling of Prescriptions
• 460.500 Prescription Drugs for Ship's Medicine Chests
• 460.600 Content Uniformity Testing of Tablets and Capsules
• 460.700 Controlled Release Dosage Form Drugs-Rate of Release of Active Ingredients

More on CPGs next week.

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

USP Responses to <800> Questions

USP responses to the <800> questions are now in the updated <800> FAQs on the USP website and can be accessed at:
http://www.usp.org/frequently-asked-questions/hazardous-drugs-handling-healthcare-settings

News

Heavy Hydrogen (Deuterium) Makes Drugs Last Longer in the Body
Substituting a heavier form of hydrogen into drugs can slow their breakdown by the body, leaving them in the bloodstream longer. In other words, a patient can take the drug less often and this may even reduce the severity of side effects. The technology has been around for 40 years, but it has taken that long to understand it sufficiently to bring such a treatment before the FDA. The FDA is reviewing what would be the first medicine made with deuterium, or heavy hydrogen; a drug to treat a symptom of Huntington's disease. Teva hopes to submit more data to the FDA by the end of the month and hope the drug will reach patients next year.
http://www.bloomberg.com/news/articles/2016-09-16/a-decades-old-drug-technology-finally-nears-its-big-breakthrough?cmpid=yhoo.headline

Drug Companies Promise to Clean up Antibiotic Factories and Help Curb Overuse
Thirteen leading drug companies have promised to clean up pollution from factories making antibiotics and to take steps to curb overuse of antibiotics as part of a drive to fight the rise of drug-resistant superbugs. Companies signing up include leaders in both branded and generic drug production; companies include Pfizer, Merck, Novartis, GlaxoSmithKline, and Allergan, as well as Indian drugmakers Cipla and Wockhardt.
http://www.reuters.com/article/us-un-assembly-antibiotics-idUSKCN11Q1AA

Doctors to Charge for Missed Medicaid Appointments?
It may be up to a year before a new state law allowing doctors to charge Medicaid patients late fees for missing an appointment goes into effect. However, even then the future of the controversial law in Missouri remains in limbo. It gives doctors the ability to refuse to schedule new appointments until the missed appointment fee is paid; the charge would be $5 for the first missed appointment, $10 for the second and $20 for the third. The law also provides for $8 co-pays if a Medicaid recipient seeks treatment in an emergency room for a non-emergency health issue.
http://www.stltoday.com/news/local/govt-and-politics/late-fees-and-co-pays-for-missouri-medicaid-recipients-could/article_3d1a8976-55b7-5270-9c9c-6c82e1af902f.html

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Did You Know ...

�that it's an interesting thing about life–if you refuse to accept anything but the best, you usually get it?

Tip of the Week

Just getting by has never built and maintained a great profession or a great nation. It takes a goal of being the best and working together towards that goal.

Looking Back

Grandpa knows,
It ain't too late,
He's gone to get,
Some widder bait!
     Burma Shave