From APC’s President

The late ’90s say hello

Michael Blaire, RPh, FIACP
APC President

It was back in 1997* that Congress passed the Food and Drug Administration Modernization Act, or FDAMA, which amended the FD&C Act by, among other actions, adding section 503A to Chapter 5.

One requirement of Section 503A was the development of a memorandum of understanding with the states concerning the interstate distribution of compounded preparations. Without going into the various legal arguments, parts of Section 503A were ruled unconstitutional in 2003 and removed from the FDCA.

Fast forward to 2013, following the NECC tragedy. Section 503A, now 16 years old, is given a new name (“the Drug Quality and Security Act”) and inserted back into the FDCA, the unconstitutional parts removed. Unfortunately, the requirement for an MOU still remained.

For many reasons, it seems that FDA is trying to fit a 24-year-old square peg into a modern-day round hole. As with computers, a lot has changed in the regulation of compounding pharmacies since 1997. One thing that has not changed: There are 50 states.

When FDA conceived the MOU, “the states” were treated as single uniform entity rather than 50 unique agencies, each with its own assignment of jurisdiction, approach to the regulation of pharmacy, due process, and information sharing. It would be an understatement to say that many were not happy with the requirements of the final MOU that was released in October 2020.

Since then, many state boards of pharmacy have pushed back on the MOU, primarily registering their complaints through NABP. At the urging of APC and several state boards, on April 27 NABP sent a strongly worded letter to FDA requesting a one-year extension to the implementation date of the MOU.

This week, that letter received reinforcement. Citing the fact that several states are unable to sign the MOU due to existing state laws that cannot be amended in time to meet the October 2021 deadline, Reps. Henry Cuellar and Neal Dunn, who worked closely with APC, are circulating a “Dear Colleague” letter, asking fellow congressmen and -women to sign the letter to be sent to FDA, also requesting a delay in the implementation of the MOU.

Now it’s up to all of us to get our representatives to add their names to that letter. Send an email. Make a phone call. Visit the district office. Do whatever it takes to get the message out and a signature on the letter.

Stop. Don’t just skim that last paragraph. Right now, make that call or send that email. It takes five minutes, tops, to say, “I’m a constituent and I’d like to ask Representative ______________ to respond to the ‘Dear Colleague’ letter from Congressman Dunn and sign his letter to FDA.”

FDA has waited 24 years to implement the MOU. Although the square peg may never be completely rounded, a delay of at least year may provide enough time to sand down the rough edges.

* That was the year my 50-pound desktop computer (including the CRT monitor) ran Windows 95, came with 4MB of RAM and a 200MB hard drive, and cost $2,000. Today my phone, which weighs less than 1 pound, has more than 800X the memory and 1,300X the storage, fits in my pocket, and can access the Internet from the bottom of the Grand Canyon. It cost less than $1000. Suffice to say, things have changed since 1997.

Michael Blaire is APC’s president, but his day job is vice president for government and regulatory affairs at Wedgewood Pharmacy in Scottsdale, Arizona. You can reach him at mblaire@wedgewoodpharmacy.com.

PCAC recommends three substances for 503A bulks list

FDA’s Pharmacy Compounding Advisory Committee met Wednesday, voting to recommend adding melatonin, methylcobalamin, and oxitriptan to the 503A bulks list.

PCCA’s AJ Day, a member of APC’s Board of Directors, presented on behalf of APC and NCPA in support of recommending including methylcobalamin on the list. (FDA staff had recommended that methylcobalamin not be included, but PCAC members disagreed.)

Among the committee’s actions:

• Melatonin, typically used for treatment of sleep disorders in patients with autism spectrum disorder (specifically children and adolescents), was recommended on a vote of 13-0.
• Methylcobalamin — notably a treatment for amyotrophic lateral sclerosis, pain management (peripheral neuropathy, including diabetic neuropathy), inborn errors of metabolism, hyperhomocysteinemia, vitamin B12 deficiency, and autism — was recommended by a vote of 9-5.
• Oxitriptan, also known as 5-hydroxytryptophan or 5-HTP and often used for treatment for patients with tetrahydrobiopterin deficiency, was recommended by a vote of 11-0-1.
• Finally, choline chloride, commonly used for treatment of liver diseases, atherosclerosis, fetal alcohol spectrum disorder, and supplementation in long term total parenteral nutrition, was not recommended by a vote of 2-11-1.

After the meeting, Day sought to manage expectations. “It’s just a committee vote,” he said. “FDA can still decide whatever it wants.” He also emphasized that the items were nominated, evaluated, and discussed for specific uses, but if FDA places them on the 503A bulks list, it will not be for specific uses. FDA may put parameters on the route of administration, but not the use/diagnosis. How quickly FDA will act on the PCAC recommendations is not known.

NCPA to provide in-kind support to cBHT campaign

The National Community Pharmacists Association will provide in-kind support valued at $25,000 for APC’s cBHT media campaign, APC learned this week. That support will include ongoing coverage of the campaign and ad placements in NCPA’s flagship America’s Pharmacist magazine, social media, and other communications support, and exposure at NCPA’s October annual convention in Charlotte, N.C.

“We support this important campaign and we want to help make it successful,” wrote NCPA CEO B. Douglas Hoey.

“We’re grateful for our ongoing partnership with NCPA on compounding issues, and NCPA’s in-kind support of our campaign to save compounded hormones is particularly appreciated,” said APC’s CEO Scott Brunner.

If you’re also an NCPA member, look for campaign messaging coming soon – and maybe shoot Doug a quick thank you!

Help us gather shortage data on HCG

FDA has granted a request from APC and the Outsourcing Facilities Association for a listening session related to restrictions on compounding HCG that have resulted from the March 2020 reclassification of the drug as a biologic. That listening session is set for July 20.

Because HCG does have a drug monograph, the restriction creates a conflict of laws and stands to deprive some patients of an otherwise viable treatment option.

Between now and July 20 APC is gathering documentation of shortages or other interruptions in availability of HCG products from wholesalers and distributors. That documentation must come from compounding pharmacies and outsourcing facilities like yours. We’re speaking here not of your own internal documentation, but of documentation directly to you from the wholesaler or distributor, either in writing or via screen shots of the vendor’s software. Please scrub any examples you share with us to remove confidential pricing or other data.

In addition, note that we need ongoing documentation, not only a single point in time. Best to begin to collect the data, say, weekly, and share it with us prior to July 20.

APC will hold confidential all sources and senders of HCG shortage/unavailability data.

Send documentation to info@a4pc.org, and mark it as “HCG shortage documentation.”

MedQuest hosts Rep. LaHood

Rep. Darin LaHood (IL) visited MedQuest Pharmacy in Salt Lake City today. He’s a previous sponsor of APC priority legislation, so owner Jeff Bray thanked him during the tour of the pharmacy.

Pharmacist Ryan Young (left) and Rep. LaHood

YOU should invite a legislator to tour your pharmacy. Click here for our how-to guide!