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

This week we will continue our discussions on the USP General Notices by covering the remaining portion of part 10. Next week we will discuss the recently held NIH Symposium on pediatric formulations.

Of special interest in this section is the definition of "storage temperatures." The section on storage temperature and humidity defines the temperature ranges for each of the specified conditions: freezer (-25 to -10�C), cold (<8�C), cool (8-15�C), controlled cold temperature (2-8�C), room temperature (temperature prevailing in working area), controlled room temperature (20-25�C), warm (30-40�C), and excessive heat (>40�C). Regarding humidity, it states that a "dry place" is one that does not exceed 40% average relative humidity at Controlled Room Temperature or the equivalent water vapor pressure at other temperatures.

The section on "labeling" defines labeling as all labels and other written, printed, or graphic matter upon an immediate container of an article or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container. The term "label" designates that part of the labeling upon the immediate container. The label strength of a drug product is expressed in terms of micrograms, milligrams, or grams, or percentage of the therapeutically active moiety or drug substance, whichever form is used in the title unless otherwise indicated. The labeling discussions also include leading and terminal zeros, labeling of salts of drugs, vitamin-containing products, botanical-containing products, parenteral and topical preparations, electrolytes, alcohol, and special capsules and tablets.

"Expiration dates" for commercial manufactured products and "beyond-use dates" for compounded preparations are discussed, as well as guidelines for packaging and storage statements in the USP-NF.

This is the last portion of section 10. Many of these topics directly impact pharmaceutical compounding. One is encouraged to review these in the USP for confirmation of compliance.


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

Fenofibric Acid May Not Lower Heart Attack Risk
After all these years, the FDA has now ordered that the label for Trilipix (fenofibric acid) be changed to indicate that it has not been shown to reduce the risk of heart attack or stroke. This comes as a result of data from the ACCORD Lipid trial.
http://www.medpagetoday.com/Cardiology/Dyslipidemia/29547

Compounded 17P Being Probed by FDA After KV Complaint
KV hired a Cambridge Massachusetts company named Fuld & Co. to acquire samples of hydroxyprogesterone caproate API from suppliers (10 samples from Chinese suppliers) and finished compounded preparations from 30 different compounding pharmacies in 15 states. The samples were then tested in KV laboratories. KV states that 8 of the 10 API samples and 16 of the 30 finished preparation vials failed to meet FDA standards for unknown impurities; one of ten failed API FDA potency standards according to KV. KV stated that one of the Chinese API samples was found to be glucose rather than hydroxyprogesterone caproate.
http://www.fiercepharma.com/press_releases/fda-statement-makena-1?utm_medium=nl&utm_source=internal

KV Faces Class-action Lawsuits Related to Makena
KV Investors have filed three class-action lawsuits against KV alleging that KV gave false and misleading information about Makena. The lawsuits say KV knew or had reason to believe that FDA may not provide protection of the company's exclusivity for Makena, among other allegations.
http://www.stltoday.com/business/local/investors-sue-kv-pharmaceutical-alleging-misleading-statements/article_f321bc29-d33c-5f71-b66a-616124618c69.html

Honey Isn't Honey Any More?
Most honey that is purchased in grocery stores today isn't "honey" according to the official definitions of honey. Honey must contain the bee pollen to be honey whereas today's honey is more purified. Most honey today is heated and forced at high pressure through very small filters to remove the pollen (which is the only foolproof method of identifying the actual source of the honey). Whereas most grocery stores sell the filtered honey, some of the natural stores and honey labeled "organic" honey usually still contains the pollen and is honey according to the official definition.
http://foodsafetynews.com/2011/11/tests-show-most-store-honey-isnt-honey/

Public Health Group Wants Sodium Reduced
The American Public Health Association has passed a resolution calling for federal regulation of sodium in foods. Their goal is to reduce sodium in restaurant and processed foods by 75% in ten years through FDA regulation; this could be triggered by removing or changing the status of sodium from its current recognition of GRAS (generally recognized as safe).
http://www.mediapost.com/publications/article/161538/public-health-group-fda-should-regulate-sodium.html

Lifestyle Drugs Increasing—But at What Price? Drug to Prevent Gray Hair Might Be Next in 'Lifestyle' Drug Pipeline
The lifestyle drug market is booming worldwide; it seems to pit problems of social or cosmetic nature against conditions threatening physical health or well-being. Some question whether or not vanity should assume equal importance pharmaceutically to authentic medical conditions.
http://consumer.healthday.com/Article.asp?AID=658000

�that it has been said, "What one person receives without working for�another person must work for without receiving?"

�that today is 11.11.11 (November 11, 2011).

Veterans Day
Veterans Day is intended to honor and thank all military personnel who served the U.S. in all wars, particularly living veterans. Many communities celebrate it by parades and church services and in many places the American flag is hung at half-mast. A period of silence lasting two minutes is often observed at 11 am.

PCAB
Congratulations to Johnathan Lehan of Lehan Drugs in Sycamore, Illinois for earning PCAB accreditation. He is accredited in nonsterile compounding.