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Editorial: More on the United States Pharmacopeia General Notices, Part III

Section 2 of the United States Pharmacopeia (USP) General Notices is titled "Official Status and Legal Recognition." Although not an exciting section to read, it does provide the necessary definitions and legal status necessary to understand the USP and its role.

Recognition
The USP and National Formulary (NF) are recognized in laws and regulations not only in the U.S. but in many other countries. It could have the most far-reaching impact of any pharmacopeia in the world. In the U.S., the Federal Food Drug and Cosmetic Act (FDCA) recognizes both the USP and NF as official compendia. A drug with a "name" that is officially recognized in the USP–NF is required to comply with compendial identity standards or is considered to be adulterated, misbranded, or both. The drug must comply with compendial standards for strength, quality, and purity, unless the label reveals any aspect in which the drug differs from the official standards. The drug must also be packaged and labeled according to the compendial standards. As the USP has no enforcement ability, the standards developed are enforced by the FDA and other government authorities in the U.S. and elsewhere.

Definitions
Official Article: is an article recognized in the USP or NF. Official articles include both "official substances" and "official products."
Official Substance: is a drug substance, excipient, dietary ingredient, other ingredient, or component of a finished device for which the monograph title includes no indication of the nature of the finished form.
Official Product: is a drug product, dietary supplement, compounded preparation, or finished device for which a monograph is provided.
Official Title: is the title specified in a monograph. It should be noted here that other names considered to be synonyms of these official titles may not be used as substitutes for official titles.
Official Text: is text that is contained in the USP and NF and includes monographs, general chapters, and General Notices. Revisions to the official text are provided through Supplements, Interim Revision Announcements and Revision Bulletins that were discussed in the second part of this series.

General Chapters
Another area in this section describes General Chapters and their numbering scheme, as follows:

Less than <1000>: Contains mandatory and enforceable standards and requirements
<1000>–<1999>: These chapters are interpretive and provide information on or give definition to, a specific subject. They originally were linked to specific test requirements as a further explanation, but now contain more information.
<2000>–<2999>: These chapters apply only to articles intended for use as dietary ingredients and dietary supplements.

Next week we will look at "Conformance to Standards" as we continue our educational journey through the General Notices of the USP–NF.


Loyd V. Allen, Jr., Ph.D., R.Ph.
Editor-in-Chief

Primatene Mist Not Available in the U.S. after this Year
The FDA is now reminding doctors and patients that Primatene Mist can no longer be sold or prescribed after December 31, 2011. Primatene Mist is the only nonprescription asthma inhaler in the U.S. and asthma patients need to get prescriptions for alternative medications. The reason for discontinuing the drug is that it contains chlorofluorocarbons and the U.S. signed an international agreement—The Montreal Protocol on Substances that Deplete the Ozone Layer—to phase-out the compounds; these inhalers could not be made or sold in 2012.
http://thechart.blogs.cnn.com/2011/09/22/no-more-primatene-mist-in-the-u-s-after-this-year/

VA Will No Longer Use Avastin for Eye Disease
The Department of Veterans Affairs has stopped using Roche's Avastin to treat a sight-robbing eye disease as it looks into reports of increased risk of infection. After the investigation is complete, VA will reassess how Avastin and similar therapies may be made available for ophthalmologic use and will issue further guidance. A large U.S. government-sponsored study released in April found that Avastin works just as well as Lucentis for the eye disease, but had more side effects that required hospitalization. Avastin is much less expensive than Lucentis.
http://www.reuters.com/article/2011/09/21/us-roche-va-idUSTRE78K6F520110921

Indian Active Pharmaceutical Ingredient Facility Issued Strong Warning Letter
Yag-Mag Labs Private Limited of India has received a strongly worded warning letter, hitting the active pharmaceutical ingredient (API) manufacturer with an import alert. The letter states the company's Hyderabad facility "was not adequately designed to facilitate cleaning and minimize the potential for contamination." Inspectors saw "residues and corrosion on processing equipment," leaky piping, standing water, and unsanitary restroom facilities, among other observations. As another example, prior to April 2011, the facility did not use cleaning logs and it was reported to the investigator that no cleaning was performed; there is no evidence exists that cleaning occurred "between batches or between product changeovers...for non-dedicated equipment." Yag-Mag responded by admitting its facility "was not up to the mark of FDA..." and that corrective certain actions were needed but not yet completed. The FDA import alert means that all articles manufactured by the company will be refused entry into the U.S.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm271708.htm

Reformulation Targeted in FDA Unapproved Drug Plan
The FDA is looking at companies that reformulate drugs to evade enforcement as it cracks down on the thousands of products marketed without approval. Due to many reasons, thousands of products, based on hundreds of APIs, are marketed without approval from the FDA. Resources directed at this effort are limited, and, as such, the FDA is taking a risk-based approach to enforcement.
http://www.in-pharmatechnologist.com/Materials-Formulation/Reformulation-targeted-in-FDA-unapproved-drug-plan

Roche Stops Delivering Cancer Drugs to Hospitals in Greece
Swiss drug giant Roche Holding AG has stopped delivering its drugs for cancer and other diseases to some state-funded hospitals in Greece. There are hospitals that haven't paid their bills in three or four years, and the company may take similar steps elsewhere. This is yet another strong example of how the European debt crisis that has jolted global financial markets is having a direct effect on consumers.

Roche is boosting deliveries to Greece pharmacies which have paid their bills more reliably. The new measures may need to be adopted in Spain, and some state-funded hospitals in Portugal and Italy have also fallen far behind on payments. The company says there comes a point where the business is not sustainable anymore.
http://online.wsj.com/article/SB10001424053111904491704576574791877220786.html

�that all the ophthalmic formulas in the out-of-print Extemporaneous Ophthalmic Preparations book by Reynolds LA and Closson RG are included in the formulas in the CompoundingToday.com website? Also, a new book on ophthalmic formulations is being prepared by Linda F. McElhiney to be published by APhA.

USP/CDC Joint Public Health Webinar a Great Success
Over 250 healthcare professionals attended the USP/CDC joint public health webinar addressing the factors that resulted in the contamination of compounded TPN causing an outbreak of Serratia marcescens in adult patients. The webinar informed participants regarding the lessons learned from the CDC perspective including a review of the investigation and the breaches identified and from USP who provided a review of the official standards necessary for sterile compounding and patient safety. The presenters included Dr. Neil Gupta, a board-certified Internist who serves as an Epidemic Intelligence Service Officer in the Division of Healthcare Quality Promotion at the CDC in Atlanta, and Eric Kastango, a member of the 2010-2015 Compounding Expert Committee represented USP in presenting General Chapter <797> Pharmaceutical Compounding—Sterile Preparations guidelines as they relate to safe compounding of High-Risk Sterile preparations.

The free Webinar was recorded and will be posted on the USP web page (www.usp.org) next week for viewing by all.

Pharmacy Compounding Accreditation Board NEWS
The Pharmacy Compounding Accreditation Board (PCAB) is proud to announce the accreditation of the following pharmacies:

1. Potter's House Apothecary; Peoria, AZ; High Complexity Sterile & Non-Sterile Compounding
2. Medical Center Pharmacy; Wilmington, NC; High Complexity Sterile & Non-Sterile Compounding

A complete list of PCAB accredited pharmacies may be found at: http://www.pcab.info/find-a-pharmacy.shtml

Webinar
If you did not participant in the USP/CDC webinar this week, please take an hour and view it online next week on the USP web page as described below. The reasons for the TPN contamination event in Alabama are very well presented and provide lessons for all.

Pharmacists and Techs Needed
Compounding pharmacy is currently seeking for pharmacists and pharmacy technicians who have experience in compounding. Knowledgeable in Micro Merchant is a plus. Must have good communication skills and customer relations. Competitive salary / optional benefits. Contact Stan 347-533-4845 / 718-496-8246. Email resume at megaaidpharmacy@yahoo.com.