Due to the number of requests received, all of the articles, newsletters, etc. related to Professional Practice Standards and the "lack of authority" of the United States Pharmacopeia (USP) General Chapters (<795>, <797>, <800>) have been compiled into one document which can be downloaded FREE at the Compounding Today website. Go to:

Since the responsibility for pharmacy laws, regulations, and practice standards belong to the individual state boards of pharmacy, these materials can be used to support the transition from relying on USP's chapters to state-developed regulations and standards.

It appears the state boards use of the USP materials has fallen into 3 categories:

1. Not use the USP professional practice chapters.
2. Rewrite the USP professional practice chapters according to the uniqueness of an individual state.
3. Incorporate by reference the USP professional practice chapters.

Utilizing numerous materials that are available, individual state boards can develop their own professional practice standards for their states that are science-based and reasonable. Not all content or sections of published standards may be reasonable in all states. It is up to the individual state to determine what it is or is not appropriate for their state. The individual state can reference numerous documents and incorporate their respective state nuances. There are many individual considerations various states can make so that quality professional practice standards are more workable.

It is important that pharmacists from ALL practice settings have input with their individual boards and provide information, documentation, and support in whatever way is needed. It is important for all to be involved in setting standards to enhance quality compounding and ensure patient access to individualized medications.

Note: Next week we will begin a new series on the Compliance Policy Guidelines published by the FDA related to pharmacy compounding/practice. Due to the above announcement, it was decided to postpone beginning the FDA CPG discussions until 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

News

Antibacterial Soap Disappearing
Antibacterial soaps will soon disappear from store shelves says the FDA, as they provide no benefits over regular soap. Products with 19 antibacterial ingredients, including triclosan and triclocarban, must be reformulated or removed from stores within a year.

NOT covered by this ruling are hand sanitizers and wipes designed to be used without water and containing more than 50% alcohol and cleansers in hospitals or nursing homes.

Triclosan and the other 18 ingredients are present in more than 2,100 products, or roughly 40% of the soaps on the market. Manufacturers have not demonstrated that they are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.

The FDA will allow products with another three ingredients to remain on the market for the moment. Manufacturers have until February to present information on the safety of products containing benzalkonium chloride, benzethonium chloride, and chloroxylenol.
http://www.usatoday.com/story/news/2016/09/02/antibacterial-soap-soon-disappear/89774728/

Note from Editor: Here is a list of the newly banned chemicals:

• Cloflucarban
• Fluorosalan
• Hexachlorophene
• Hexylresorcinol
• Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
• Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
• Methylbenzethonium chloride
• Nonylphenoxypoly (ethyleneoxy) ethanoliodine
• Phenol (greater than 1.5%)
• Phenol (less than 1.5%) 16
• Poloxamer-iodine complex
• Povidone-iodine 5% to 10%
• Secondary amyltricresols
• Sodium oxychlorosene
• Tribromsalan
• Triclocarban
• Triclosan
• Triple dye
• Undecoylium chloride-iodine complex

Pan Drugs of India Warned-Data Integrity and Sanitation (Rodents/Lizards)
For the second time in less than a year, the FDA has issued a warning letter to Indian active pharmaceutical ingredient maker Pan Drugs over data integrity and sanitation violations. Due to the extent and repeated nature of the violations, the FDA says Pan must carry out a comprehensive plan to investigate and address the issues.

The warning letter also cites Pan for failing to keep its facilities and equipment clean, noting the presence of mold, rodent feces, and a lizard in the company's processing area, as well as rust and dirt on some of its manufacturing equipment. According to the FDA, a Pan representative told investigators the company "had no cleaning procedure for the equipment or facility."
http://www.raps.org/Regulatory-Focus/News/2016/09/07/25793/FDA-Warns-Pan-Over-Data-Integrity-Sanitation-Issues/#

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Did You Know ...

�that as a follow-up from last week's list of incredible achievements of the U.S. in WWII, Dr. Dennis Worthen submitted the following?:

"At least 11,000 pharmacists and student pharmacists served in the U.S. Armed Forces. At least 173 died on active duty."

Tip of the Week

Pharmacists (Apothecaries, etc.) have played important roles in all human activities throughout history, in both peacetime and wartime. Pharmacists continue today to serve society in many ways. It is important to be involved as pharmacy is our profession. To learn more about how some have served, please read both volumes of "Heroes of Pharmacy: Professional Leadership in Times of Change" by Dennis B. Worthen. These books are available through the American Pharmacists Association at www.pharmacist.com/shop_apha.

Looking Back

Burma-Shave was
Such a boom!
They passed the bride
And kissed the groom!
     Burma Shave