To be in compliance with Section 503A of the FD&C Act, there are conditions that must be satisfied for drug products compounded by a licensed pharmacist or licensed physician to be exempt from the requirements of compliance with GMPs, labeling with adequate directions for use, and FDA approval prior to marketing the drug.

One of the requirements to qualify for these exemptions, and be able to do compounding for specific patients as prescribed by a physician, include the individual states entering into a Memorandum of Understanding (MOU) with the FDA in order to send compounded prescriptions to other states.

The Draft MOU involves a drug product that is compounded in a State that:

• Has entered into an MOU with the FDA that addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or
• Has not entered into an MOU with the FDA and the licensed pharmacists, licensed pharmacy, or licensed physician who distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

The DQSA directs the FDA to develop a standard MOU for use by the States in complying with the law.

Note:

• The first Draft MOU was back in 1999 and received over 6,000 comments.
• The second Draft MOU was issued in 2015 and reportedly received about 3,000 comments.
• The third and current Draft is dated September 7, 2018.
• Comments are due in 90 days.

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

Cigna-Express Scripts Merger Not for Low-cost Drugs
The Cigna-Express Scripts merger Monday cleared one more hurdle to combining the health insurer and pharmacy benefit manager (PBM). But industry insiders say the bid likely won't improve the high-prescription drug costs facing employers and employees.

Only a quarter of employers say they're optimistic that mergers between health plans and PBMs will have a positive impact on cost, quality, and consumer experience. The majority of employers (56%) are skeptical that they will see improvement from consolidation, and another 18% believe these mergers will lead to higher costs. Cigna's deal for Express Scripts came on the heels of CVS Health's $68 billion deal to buy insurer Aetna. The recent mergers represent a rapidly changing market.
https://www.benefitnews.com/news/employers-caution-cigna-express-scripts-merger-not-a-prescription-for-low-cost-drugs?feed=00000152-18a5-d58e-ad5a-99fd665c0000

Independent Pharmacies Vanishing in the Northland
Doug White has the only pharmacy in Proctor, Minnesota and is one of the few remaining independent pharmacies in the Northland. White owns the pharmacy and is also one of the pharmacists. The least of Doug White's worries is another pharmacist coming to Proctor to compete with him. "If anybody tried to open, they'd have some misinformation," the owner of LTC Prescription Providers said with a chuckle. White, 60, founded the pharmacy in 1999 in a building that previously had housed another drug store but had been vacant for about two years. http://www.duluthnewstribune.com/business/healthcare/4497118-independent-pharmacies-vanishing-breed-northland

What Do Pharmacists Know About Potential Pet Poisons?
An increasing number of veterinary clients are choosing to fill pet prescriptions through human pharmacies; however, veterinary pharmacology is not a required component of pharmacology training programs in the U.S. A recent article in Pharmacy Practice evaluated the baseline knowledge of licensed pharmacists with regard to common pet toxins.

Pharmacists were given a list of 25 substances and asked to evaluate the potential toxicity of each for either a cat or dog. Fifteen true toxins and 10 nontoxins were included in the list:

Respondents were able to classify 15 of 25 items (60%) correctly as toxic or nontoxic; only 50% of pharmaceutical substances were classified appropriately.
https://www.americanveterinarian.com/news/what-do-pharmacists-know-about-potential-pet-poisons

Did You Know ...

�that Winston Churchill said the following?: "One person with conviction will overwhelm a hundred who have only opinions!"

Tip of the Week

One doesn't have to look very far to observe the above statement in action. Whether one looks at politics or organizations, the individual that is committed and active will have much more influence than the one that sits back and watches things go by. As compounding pharmacists, the time of "sitting back and observing" has got to be a thing of the past. It takes action, correct motives, and a solid education knowing the facts to have a great influence and protect patient access to individual compounded medications!

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Looking Back

If you don't know,
Whose signs these are,
You can't have
Driven very far!
     Burma Shave