This 2017 position statement updates the 2012 Hormone Therapy Position Statement of The North American Menopause Society (NAMS). This paper has some statements regarding compounding that are true, some that are untrue, and some that are misleading.

The position statement discusses bioidentical hormone replacement therapy (bHRT) and compounded hormones. The paper states the following:

• Government-approved bioidentical (similar to endogenous) [hormone therapy] HT, including estradiol, estrone, and MP (Micronized Progesterone), are regulated and monitored for purity and efficacy, sold with package inserts with extensive product information (based on RCTs), and may include black-box warnings for AEs.
• Compounded hormone therapies are prepared by a compounding pharmacist using a provider's prescription and
  • may combine multiple hormones (estradiol, estrone, estriol, dehydroepiandrosterone [DHEA], testosterone, progesterone),
  • use untested, unapproved combinations or formulations, or
  • be administered in nonstandard (untested) routes such as subdermal implants, pellets, or troches.

They summarize this portion by stating that prescribers should only consider compounded hormone replacement therapy if women cannot tolerate a government-approved therapy for reasons such as allergies to ingredients or for a dose or formulation not currently available in government-approved therapies.

Taking issue with some of their statements, let's look at the following:

• FDA does not approve drug substances, only finished drug products containing drug substances.
• The FDA-approved drug products, by law (DQSA) contain the same identical drug substances that are used in compounded preparations and often come from the same sources and are
  • required to meet USP standards,
  • be contained in FDA approved products, or
  • be listed on an approved list (the bulks list) compiled by the FDA.

Since the active pharmaceutical ingredients are the same, are held to the same pharmacopeial standards in both manufactured and compounded HT preparations, and must be accompanied by a Certificate of Analysis, are they not tested? They are the same identical ingredients used in commercial products, so are they not generally safe and efficacious? Also, compounded preparations often contain the same combinations as commercial products but in different dosages and dosage forms, based on the needs of the patient. Many of the dosage forms compounded do not have sufficient market potential for a drug company to be out the expense to put them on the market for the limited return.

Next week, let's look at "unapproved" drugs and just how many unapproved drugs are on the U.S. market.

Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition

Announcement

There will be a "Drug Quality Security Act Conference" on November 15, 2017 in Washington, DC. It is sponsored by the Food and Drug Law Institute (FDLI). Go to the following website for more information:
https://www.fdli.org/2017/11/drug-quality-security-act/

News

Pharma's Puerto Rico Problems Could Mean Drug Shortages for the U.S.
U.S. Food and Drug Commissioner Scott Gottlieb said the country may start to see a small number of drug shortages within two or three weeks due to delays in restoring manufacturing operations in Puerto Rico, where 10 percent of drugs prescribed in the U.S. are made.

Drug companies are working to get facilities fully online, but face an uncertain power supply and difficulty obtaining materials used in the manufacturing process. "A lot of companies say they're online, but they basically have one of five lines running at 20 percent or 80 percent or 50 percent," FDA Commissioner Scott Gottlieb said. "They are not manufacturing at full capacity. They are manufacturing well short of that. It's unclear when they are going to be able to bring that up to full capacity," he said.

There are 40 drugs made in Puerto Rico that could face shortages, but specific products have not been named. Most major drug companies have manufacturing facilities on the island, including Merck & Co, Johnson and Johnson, Amgen Inc, Bristol-Myers Squibb Co, Eli Lilly and Co, Pfizer Inc, AstraZeneca, and GSK. There are 14 products sourced solely in Puerto Rico on the list of drugs being closely monitored by the FDA.

Did You Know ...

�that the FDA is looking at changes to its current regulations on compounding pharmacies, potentially removing some of the scrutiny from smaller 503A pharmacies?

Tip of the Week

FDA commissioner Scott Gottlieb states that the Agency is working on a policy aimed at encouraging more compounding pharmacies to register under the DQSA.
http://drugtopics.modernmedicine.com/drug-topics/news/fda-considers-compounding-pharmacy-regulations

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Looking Back

Feel your face,
As you ride by,
Now don't you think,
It's time to try,
     Burma Shave