Question: What drugs are under consideration for the "bulks list" that we can still use for compounding?

Answer:

The FDA's revised final guidance of January 2017, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry, is in place while the FDA develops the 503A bulks list. As previously discussed in this Newsletter, the FDA has divided the drugs nominated for inclusion in the bulks list into 3 categories. We will only look at Category 1 here.

Category 1:

These substances may be eligible for inclusion on the list of bulk drug substances that can be used in compounding under section 503A, were nominated with sufficient information for FDA to evaluate them, and do not appear on any other list. FDA does not intend to take action against a compounder for compounding drugs using bulk drug substances listed in Category 1, provided that the conditions described in the guidance document are met.

The drugs listed in Category 1, updated November 6, 2018, include the following.

• 7 Keto Dehydroepiandrosterone
• Acetyl L Carnitine/Acetyl-L- carnitine HCl
• Acetyl-D-Glucosamine
• Alanyl-L-Glutamine
• Aloe Vera/Aloe Vera 200:1 Freeze Dried
• Alpha Lipoic Acid
• Artemisia/Artemisinin
• Astragalus Extract 10:1
• Boswellia
• Brilliant Blue
• Cantharidin
• Capsaicin Palmitate
• Choline Chloride
• Chondroitin Sulfate
• Chrysin
• Coenzyme Q10
• Creatine Monohydrate
• Curcumin
• Deoxy-D-Glucose
• Dichloroacetate
• Diindolylmethane
• Dimercapto-1-propanesulfonic acid (DMPS)
• Diphenylcyclopropenone (DPCP)
• EGCg
• Ferric Subsulfate
• Glutaraldehyde
• Glutathione
• Glycolic Acid
• Glycyrrhizin
• Kojic Acid
• L-Citrulline
• Melatonin
• Methylcobalamin
• Methylsulfonylmethane (MSM)
• Nettle leaf (Urtica dioica subsp. dioica leaf)
• Nicotinamide Adenine Dinucleotide (NAD)
• Nicotinamide Adenine Dinucleotide Disodium Reduced (NADH)
• Oxitriptan
• Piracetam
• Pregnenolone
• Pyridoxal 5-Phosphate Monohydrate
• Pyruvic Acid
• Quercetin/Quercetin Dihydrate
• Quinacrine Hydrochloride (except for intrauterine administration)
• Resveratrol
• Ribose (D)
• Rubidium Chloride
• Silver Protein Mild
• Squaric Acid Dibutyl Ester (aka dibutyl squarate)
• Tea tree oil (Melaleuca alternifolia leaf oil)
• Thymol Iodide
• Tranilast
• Trichloroacetic Acid
• Ubiquinol 30% Powder
• Vanadium
• Vasoactive Intestinal Peptide

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

Youth Tobacco Use Increased During 2017-2018
About 4.9 million middle and high school students were current users (used in the past 30 days) of some type of tobacco product in 2018, up from 3.6 million in 2017. This increase—driven by a surge in e-cigarette use—erased past progress in reducing youth tobacco product use. With the exception of e-cigarettes, no change was found in the use of other tobacco products, including cigarettes, resulting in a net increase in overall tobacco product use during 2017-2018. Robert Redfield, M.D., CDC Director stated,

"The skyrocketing growth of young people's e-cigarette use over the past year threatens to erase progress made in reducing youth tobacco use. It's putting a new generation at risk for nicotine addiction. Despite this troubling trend, we know what works and we must continue to use proven strategies to protect America's youth from this preventable health risk. Youth use of any tobacco product, including e-cigarettes, is unsafe."

FDA to Strengthen Regulation of Dietary Supplements
The use of dietary supplements has become a routine part of the American lifestyle; three out of every four American consumers take a dietary supplement on a regular basis. For older Americans, the rate rises to four in five. Also, one in three children take supplements, either given to them by their parents or, commonly in teens, taking them on their own. What was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 - and possibly as many as 80,000 or even more - different products available to consumers.

The FDA has announced a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/
ucm631065.htm

McKesson Substituted OTC Analgesics in Bottles of Rx Opioids
McKesson Corp. sent pharmacies prescription opioids that had been removed from their bottles and replaced with over-the-counter painkillers, the Food and Drug Administration said. In a warning letter dated February 7 to CEO John Hammergren, the FDA said inspections of McKesson's headquarters in San Francisco and a distribution facility in Oregon last year found the company had failed to respond adequately after being notified by regulators and drugstore customers about the tampered bottles. McKesson's alleged violations show how the legitimate drug-supply chain can be exploited to divert opioids to the illegal market.
https://www.bloomberg.com/news/articles/2019-02-12/mckesson-sent-pharmacies-tampered-opioids-fda-says-in-warning

Did You Know ...

...that Walt Disney said the following?

"The difference between winning and losing is most often not quitting"!

Tip of the Week

It's interesting that kids often want to be a "rock star" or "famous athlete;"" they get the guitar or some new $300 athletic shoes and for the next 48 hours or so, they are on top of the world. But...when they can't immediately perform like a rock star or an athlete, they often give up and quit! I guess we adults are like that too. We want to be the best, to be successful, or make our mark and leave a legacy, but that takes a lot of work and effort. However, for some individuals during their lifetime, either internal or external factors prevent that from occurring. It is so encouraging to see those that are struggling with physical difficulties keeping on, not quitting, and winning! What a lesson we can learn from them and those that support them!

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Looking Back

Soap may do,
For lads with fuzz,
But sir, you ain't
The kid you wuz
     Burma Shave