The United States Pharmacopeia (USP) has just announced a revised General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The revision removes the reference to sterile preparations in the section General Guidelines for Assigning Beyond-Use Dates. It states that the beyond-use date (BUD) in the table "BUD by Type of Formulation" refers to nonsterile preparations. Those involved in compounding sterile preparations should refer to General Chapter <797> Pharmaceutical Compounding—Sterile Preparation for standards on sterile compounding.

This revision supersedes the currently official General Chapter <795> and will be incorporated into the second Supplement USP 37-NF 32.

The revised chapter can be downloaded at:

http://www.usp.org/sites/default/files/usp_pdf/EN/gc795.pdf

Next Week: Clinical Pharmaceutics and Generics

News

Health Canada Bans Hospira-Italy Plant Drugs
The FDA noted a number of problems in their Warning Letter issued for a Hospira plant in Italy (Liscate), and Health Canada (HC) has decided the issue is serious enough for it to ban products coming out of the sterile-manufacturing facility. HC stated this was a result of the late March Warning Letter by the FDA. Instead of carefully investigating 103 customer complaints that related to discoloration of an injectable drug, employees at the plant decided what caused the problem without even considering that it "might have been caused by the failure to perform a step in the manufacturing process." This is only one of several situations with which Hospira is dealing, as it also has been issued warning letters by the FDA for plants in the U.S., India, and Australia. HC has compiled a list of affected products.
http://www.fiercepharmamanufacturing.com/press-releases/information-update-importation-restrictions-drugs-linked-hospira-spa-due-da

FDA on Naming Drugs Containing Salt Drug Substances
The FDA has finalized a new policy detailing how manufacturers of drug products containing salts should name their products. The first released draft form was in December 2013 following the May 2013 implementation of the USP monograph on naming new drug products (Monograph Naming Policy for Salt Drug Substances in Drug Products and Compounded Preparations). Both policies apply to drugs containing "an active ingredient that is a salt." The policy stipulates that USP will use the name of the active moiety, instead of the name of the salt, for such a drug product when creating a drug product monograph title. http://www.raps.org/Regulatory-Focus/News/2015/06/16/22699/FDA-Finalizes-New-Approach-on-Naming-Drugs-Containing-Salt-Drug-Substances/

Los Angeles Pharmacy Bills Insurer $44,000 for a One-month Supply of Resveratrol
An employee's insurance company was recently billed and paid $44,707 for a one-month supply of resveratrol. The drug is available over the counter for $157.38. The pharmacy, Warner West Pharmacy in Los Angeles, declined to answer questions. A lawyer for the pharmacy reported that "Warner West submitted a government billing code" and that "the insurance company arrived at the $44,000 based on manufacturer's recommended price." This resulted when a CBS News' employee was recently prescribed a nutritional supplement to boost his energy. He was astonished when he saw the claim the pharmacy submitted-and his insurance approved—for a one month supply: $44,707.
http://www.cbsnews.com/news/prescription-resveratrol-supplement-expensive-investigation/

Synthetic Marijuana Deaths Increased Three-fold
So far, 15 people have died in 2015 from using synthetic cannabinoids, a threefold increase from that period in 2014, as reported by the Centers for Disease Control and Prevention. Poison Center calls about the substances have also skyrocketed in the past year, confirming the federal government's view that this is a growing public health threat that needs to be eliminated.
http://www.newsweek.com/synthetic-marijuana-deaths-tripled-year-342453

http://www.latimes.com/science/sciencenow/la-sci-sn-cdc-synthetic-marijuana-cannabinoids-poison-report-20150611-story.html

http://www.nbcnews.com/health/health-news/synthetic-pot-poisonings-triple-year-cdc-finds-n373786

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Did You Know ...

�that this Sunday is both Father's Day and the first day of summer? Father's day is a celebration honoring fathers and the influence of fathers in society. Father's Day was inaugurated in the U.S. in the early 20th century to complement Mother's Day, but it was not until 1966 that President Lyndon B. Johnson issued the first presidential proclamation honoring fathers, designating the third Sunday in June as Father's Day. Six years later, it was made a permanent national holiday when President Richard Nixon signed it into law in 1972. In addition to Father's Day, International Men's Day is celebrated in many countries on November 19 for men and boys who are not fathers.

Tip of the Week

Fathers, please take time to be thankful for your children, grandchildren, great grandchildren, and great, great grandchildren (Yes, my father and mother are great, great grandparents!) and cherish the bright-colored ties and socks (Maybe you should hint about some new golf balls.).

Looking Back

Your beauty, boys,
Is just skin deep.
What skin you've got,
You ought to keep!
     Burma Shave

Classifieds

Business Opportunity:
FDA Registered Sterile Drug Manufacturer / 503B Outsourcing Facility seeks Sterile Compounding Company for joint 503B venture. Ten years' experience, Sterile manufacturing Blow Fill Seal, single and multi-use vials for injectables, ophthalmic containers, inhalation containers and syringe line. Contact: Gary Hanley, CEO SterRX/AseptPak, tel. 518 353 3210 admin@aseptpak.com