Question: What drugs, from the Category 1 list below, have been recommended by the U.S. FDA Pharmacy Compounding Advisory Committee (PCAC) AND finalized by the U.S. FDA, either approved for compounding or not approved?

Answer:

The following drugs have been approved/finalized by the U.S. FDA for inclusion in the positive "Bulks List" for compounding:

• Brilliant Blue G, also known as Coomassie Brilliant Blue G-250
• Cantharidin (for topical use only)
• Diphenylcyclopropenone (for topical use only)
• N-acetyl-D-glucosamine (for topical use only)
• Squaric acid dibutyl ester (for topical use only)
• Thymol iodide (for topical use only)

The following drugs were NOT approved for inclusion in the "Bulks List" by the U.S. FDA and cannot be used for compounding:

• Oxitriptan
• Piracetam
• Silver Protein Mild
• Tranilast

When does this take effect?

The above changes take effect March 21, 2019.

What does this mean?

The bottom line is that there are now four substances that cannot be used in compounding after March 21, 2019 in the U.S.:

• Oxitriptan
• Piracetam
• Silver Protein Mild
• Tranilast

The newly approved drugs for the official "Bulks List" as well as the remaining drugs on the Category 1 list can still be used in compounding pending their processing and consideration for the Bulks List by the PCAC.

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. The 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.

Note: From last week's listing in this Newsletter, the drugs listed in Category 1 updated by the FDA on November 6, 2018, include the following, along with those in BOLD (accepted) and strike-through (rejected).

• 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

Google to Provide Drug Disposal Locations on Google Maps
Google is partnering with the Drug Enforcement Administration, the Department of Health and Human Services, CVS, Walgreen's, and state governments to display local drug disposal locations in Google Maps. Search terms including "drug drop off near me" or "medication disposal near me," will bring up permanent disposal spots at local pharmacies, hospitals, or government buildings to dispatch of unneeded medication. The program will start with 3,500 locations nationwide. https://www.usatoday.com/story/money/2019/02/21/google-combats-opioid-epidemic-showing-disposable-locations-maps/2936714002/

CMS States that the Government Payers' Share of Healthcare Spending Will Reach 47% By 2027
CMS' Office of the Actuary released its annual National Health Expenditure Projections where it estimates that a significant increase in Medicare enrollment will drive that trend over the next several years. The aging population is a major factor in other trends as well, including a slowdown in spending in Medicaid this year. CMS estimates that 73.5 million people will be enrolled in Medicare by 2027, up from 57.2 million in 2017.
https://www.fiercehealthcare.com/payer/cms-government-payers-share-healthcare-spending-to-reach-47-by-2027

California Pharmacists Can Now Prescribe Birth Control—But Few Do
A California law going into effect in 2016 allows pharmacists to prescribe many forms of birth control. Three years later, however, only fifteen percent of California pharmacies offer the option and too few women know about it. The state approved the expansion of the scope of practice for pharmacists but offered no help on expanding awareness among consumers. While the law allows pharmacists to prescribe birth control, it doesn’t require them to do it.
http://www.calhealthreport.org/2019/02/15/pharmacists-can-now-prescribe-birth-control-but-few-do

J&J Talc Litigation—Supplier Imerys America Seeks Bankruptcy
Facing liabilities from thousands of lawsuits claiming its products caused cancer, J&J talc supplier Imerys Talc America and two associated companies filed for bankruptcy protection Wednesday. They are facing about 14,650 claims that talc products caused ovarian cancer or mesothelioma. Imerys already faces millions of dollars in verdicts and settlements in the J&J powder litigation and in one case alone, a jury ordered the talc supplier to pay $25 million. J&J faces about 11,700 lawsuits itself alleging harm from talc, according to its most recent filing. Despite its setbacks in court, J&J says the science supports its product, and it has pledged to appeal the cases it has lost.
https://www.fiercepharma.com/pharma/three-units-j-j-talc-supplier-imerys-file-for-bankruptcy-amid-talc-litigation

Did You Know ...

...that Walt Disney said the following?

"I dream, I test my dreams against my beliefs, I dare to take risks, and I execute my vision to make those dreams come true."

Tip of the Week

We can all "dream"; some will test their dreams with their beliefs; fewer still will dare to take risks; and those that persevere may achieve their vision of making their dreams come true!

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Looking Back

Drive like a
Railroad engineer,
Take it easy,
When the road's not clear!
     Burma Shave