Question: Why were the four drugs, Oxitriptan, Piracetam, Silver Protein Mild, and Tranilast, not approved for inclusion in the Bulks List for compounding?

Answer:
Note: As a follow up to the past several week's Newsletters, in this Newsletter, we will cover the reasons as provided by the FDA why "Mild Silver Protein" was not included on the Bulks List.

SILVER PROTEIN MILD
Silver protein mild, also known as mild silver protein, was evaluated for use as an anti-infective agent for ophthalmic use. Silver protein mild is not well characterized because the term "silver protein mild" is used to refer to a variety of different drug products. There are also safety concerns associated with the use of silver protein mild. It can cause argyria, which is a permanent ashen-gray discoloration of the skin, conjunctiva, and internal organs. Regarding effectiveness, silver protein mild has been found to be inferior to another treatment in clinical trials. A number of FDA-approved anti-infective agents for ophthalmic use are available and have been shown to be both safe and effective. While it has a long history of use, dating back to the early 1900s, the use of silver protein mild declined dramatically after the introduction of FDA-approved ocular anti-infectives

On balance, the physiochemical characteristics, safety issues, questionable effectiveness, and historical use of silver protein mild weigh against inclusion of this substance on the 503A Bulks List. In particular, the Agency's proposal is based on the facts that silver protein mild is not well characterized, that in clinical trials it has been found to be inferior to another treatment and numerically inferior to no treatment at all, and that chronic use may result in permanent discoloration of the conjunctiva, cornea, and/or lens. FDA proposed to the PCAC that this substance not be included on the 503A Bulks List (Ref. 8). At its meeting on February 23, 2015, the PCAC voted not to include silver protein mild on the list (Ref. 2). The proposed rule would not place silver protein mild on the 503A Bulks List.

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

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency's regulation of products containing cannabis and cannabis-derived compounds [Dated 12/20/2018]
Paragraph #6:

"Additionally, it's unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it's illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug."
[For the full release, go to:]
https://www.fda.gov/newsevents/newsroom/pressAnnouncements/
ucm628988.htm

FDA Not Objecting to Losartan with NMBA Below 9.82 ppm Remaining on the Market
To ensure patient access to losartan, the FDA will allow certain manufacturers temporarily distributing losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the impurity can be eliminated. The agency expects many companies will be able to manufacture losartan without nitrosamine impurities and replenish the U.S. supply in approximately six months.
https://www.fda.gov/drugs/drugsafety/ucm613916.htm

FDA's Departing Chief Considers Yanking Nicotine Vaping Pods Off the Market
Scott Gottlieb has squared off with two companies at the center of his efforts to halt a surge in teen vaping after a contentious meeting last week with executives from Marlboro maker Altria Group Inc. and Juul Labs Inc. Altria has taken a $12.8 billion stake in Juul, maker of a popular vaping device, while at the same time promising to increase efforts to keep kids from getting hooked on e-cigarettes. "The e-cigarette industry has been overly dismissive" of the risk that kids could become addicted to nicotine through e-cigarette use, Gottlieb said. "We're capturing an exploding epidemic right now." Gottlieb said the FDA is working on defining exactly what constitutes a pod-based product in case it needs to temporarily ban them.
https://www.latimes.com/business/la-fi-nicotine-pods-vaping-fda-20190319-story.html

Cancer Drug Recalled Over Particulate Matter Contamination
Mylan has issued a voluntary recall of two lots of a cancer drug over concerns they may be contaminated with particulate matter. Following a yearlong stability test, copper salts were discovered in two lots of Levoleucovorin Injection, the FDA said.
https://www.usnews.com/news/health-news/articles/2019-03-19/mylan-recalls-cancer-drug-over-particulate-matter-contamination

Did You Know ...

...that Pericles (430 B.C.) said the following?

"Just because you do not take an interest in politics doesn't mean politics won't take an interest in you!"

Tip of the Week

It is so sad that many, if not most, of the citizens of the U.S. do not keep up with what is going on in local, state, and national politics. When it comes to voting, how many really know what they are voting on or who they are really voting for? One thing is for sure, you can't depend on the media for news and truth any longer; it's mostly opinions with a few facts (either real, partial, or distorted) thrown in!

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Looking Back

Enthusiastic user
Henry J. McLass
Spreads our product on the lawn,
When he cuts the grass!
     Burma-Shave