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Editorial: United States Pharmacopeia 101, Part VI

This is the sixth in the series on the United States Pharmacopeia (USP). In this part, we will discuss the format and contents of the United States Pharmacopeia (USP) 35-National Formulary (NF) 30, which just became official this week. The USP/NF consists of three hardbound volumes in a hard slip-cover box, well over 5,000 pages total.

Volume 1 contains the (1) Mission Statement and Preface, (2) People of the 2010-2015 Revision Cycle, (3) Members of the U.S. Pharmacopeial Convention as of November 1, 2011, (4) 2010 Recognition of Monograph and Reference Material Donors, (5) Articles of Incorporation, (6) USP Governance, (7) Admissions, (8) Notices, (9) General Chapters, (10) Reagents, Indicators, and Solutions, (11) Reference Tables, (12) Dietary Supplements, and the NF 30 contents (Admissions, Excipients, Monographs, and a Combined Index).

Volume 2 contains (1) a Guide to General Chapters, (2) Notices, and (3) USP 35 Monographs (A through I), and (4) a Combined Index.

Volume 3 contains (1) a Guide to General Chapters, (2) Notices, and (3) USP 35 Monographs (J through Z), and (4) a Combined Index.

In summary, Volume I is useful for the Reference Tablets (solubility, physical characteristics, etc.) and the NF monographs for the excipients; Volume II and Volume III have the monographs for the drug substances and drug products/preparations.

Next week we will look at the NF and the changes it has undergone since its first edition in 1888 published by the American Pharmaceutical Association.


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

Testosterone Use Escalating in Libido Race
Eli Lilly & Co. and Abbott Laboratories are "helping" 13.8 million American men who have low levels of testosterone. In what may become one of the most sought-after sex enhancement treatments since the introduction of Viagra 14 years ago, new testosterone products from Abbott, Lilly and others are in hot demand. Prescriptions for testosterone replacement therapies have more than doubled since 2006 to 5.6 million. Men are lining up to get injections, gels, and patches to boost their testosterone. One man, 43, a home stager in New York and Chicago stated, "Am I making a deal with the devil? A little bit, but I have to think about my quality of life," Murray said. "It is like I'm in my 20s again." He doesn't have any obvious symptoms of low testosterone levels but simply wants to raise his energy level and give his bodybuilding regime a boost.

Similar to the millions of women who have opted for hormone replacement therapy, men are choosing to get their hormone levels in line. In the U.S., as many as 13.8 million men older than 45 have low levels of testosterone, according to a 2006 study in the International Journal of Clinical Practice. Male testosterone levels begin to decline after age 30 and tend to drop about 1 percent each year, though the level of decline varies. Lower levels can lead to a loss of libido, decrease in bone and muscle mass, and depression.
http://www.businessweek.com/news/2012-05-02/testosterone-chases-viagra-in-libido-race-as-doctors-fret

Medical Societies Say Pharmacists Dispensing Without Rx 'Scary'
Think about a patient walking into a pharmacy, self-diagnosing a cough at a kiosk with medical software, and then getting a drug from a pharmacist without a physician's prescription. The FDA is considering this scenario, much to the alarm of the American Medical Association (AMA) and other medical societies, which see the beginnings of an end-run around physician authority.

The FDA has been soliciting opinions on creating a new paradigm for drug approval since February. "Safe use" could mean a pharmacist assessing whether a patient has any condition or risk factor that would contraindicate the use of a particular drug, or helping a patient choose between different drugs. The FDA is also stating that with some medications, an initial visit to a clinician for a prescription would be required, but more automatic refills than usual would be allowed before a follow-up visit.

"Safe-use medications" could benefit many Americans who go untreated or undertreated for their conditions because of the "cost and time required." At the FDA hearing on March 22, two medical societies went on record objecting to the proposal for OTC safe-use drugs.
http://www.medscape.com/viewarticle/763179

FDA Expands Investigator Disqualification to All Products
With the issuance of a final regulation, on April 30, the scope of clinical investigator disqualification was expanded to any FDA-regulated product. When the FDA determines that an investigator is ineligible to receive one kind of test article (i.e., drugs, devices, new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by the FDA.
http://www.thompson.com/public/newsbrief.jsp?cat=FOODDRUG&id=3846

... that discontinued drugs are still available? The next issue of the RxTriad has a focus of informing physicians that in many cases compounding pharmacists can prepare drug products that have been discontinued. Call Deb at 1-800-757-4572 to place your order for the RxTriad.

Reach Out with the RxTriad
The RxTriad is a great marketing tool to inform your prescribers of capabilities of which they might not be aware. For example, they may not be aware that you can compound many drugs that are discontinued as well as those in short supply.

My job is
Keeping faces clean;
And nobody knows
De stubble I've seen!
      Burma Shave

PCAB is proud to announce the accreditation of the following pharmacy:

The Apothecary Shop of Columbus; Columbus, OH; Ms. Linda Cappellini, R.Ph., Director of Laboratory Services; lcappellini@theapothecaryshop.com Re-accreditation for Sterile and Nonsterile Compounding

Please join us in congratulating this pharmacy on its milestone.