For the first time in quite a while, FDA has updated its pending 503B list

For the first time in quite a while, FDA has updated its pending 503B list — the “Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act”. Interested in what’s on the list and in what category? Click here.

Check out two pieces of new research….

…from Mercatus scholars on pharmacy regulations. One demonstrates that pharmacists and pharmacy technicians are capable of performing morekinds of tasks, not fewer (an argument for expanded scope of practice). The other “summarizes years of research Mercatus scholars have conducted on the impact of certificate-of-need laws on healthcare access, quality, and cost.”

On-demand hand sanitizer education from USP

“Learn from USP, regulators, industry, and public health institutions about the global and regional quality risks and solutions when producing alcohol-based hand sanitizer.” Both courses are free and each is just under four hours long. To take it as a manufacturer, click here. To take it as a healthcare professional, click here.

Is your town hall coming up? (Hint: Better check)

Check your mail: Three APC town halls coming in June. If you’re in APC district III, IV, or VII (see the list of states below), your district’s virtual town hall is coming later this month. Be sure to check your email for date and time — it’s free for APC members and non-members! (Missed the email? Click here to send us a quick message and we’ll let you know!)

What’s on the agenda, you ask?

  • The current state of potential cBHT limits, and of APC’s Media Campaign to protect compounded hormones
  • Compounding-related legislation in Congress, including provider status
  • UPC <795> and <797> updates
  • APC’s just-introduced “Urgent Use” legislation
  • Upcoming APC meetings and educational opportunities

And more, of course.


District III: Illinois, Indiana, Kentucky, North Carolina, Ohio, South Carolina, Virginia, West Virginia
District IV: Alabama, Arkansas, Florida, Georgia, Mississippi, and Tennessee
District VII: Alaska, Arizona, California, Hawai’i, Idaho, Nevada, Oregon, and Washington.

Owner Summit: Thrice more, with feeling

APC’s urgent-use bill introduced in Congress

A bipartisan bill aimed at confronting pervasive drug shortages like those hospitals and clinics experienced during the pandemic was introduced in the U.S. House of Representatives this week.

The Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, HR 3662, is sponsored by representatives Henry Cuellar (D-TX) and Morgan Griffith (R-VA). It would create a permanent path for 503A pharmacies to provide urgent-use and shortage drugs to hospitals and physicians under strict regulatory guidelines.

The bill is an APC advocacy priority. You can read our briefing paper on the bill here.

Help us attract more sponsors: Contact your representatives and ask them to support and sponsor HR 3662. (And why not send a note of thanks to Reps. Cuellar and Griffith?)

IT’S CRUNCH TIME.

We’ve got just four weeks left to raise the final $500,000 to fund APC’s campaign to save compounded hormones.

In this brief, 5-minute video update, APC’s CEO Scott Brunner explains what’s at stake and provides a brief tour of the tools we’re providing members like you to use in supporting the campaign. We’re talking tools for your pharmacy team, tools for reaching prescribers and patients, and tools for communicating with your members of Congress about the threat to compounded hormones. They’re at A4PC.org/cBHTtools, and they are available to APC members.

About campaign funding:

We’ve got one month left to raise the last $500,000 to fund campaign ad placements. Come June 30, if we haven’t met the goal, we’ll have to immediately scale back our plans. The campaign will slow to a standstill. Please don’t let that happen.

We need your financial support to preserve your ability to treat patients. Please invest now and help us reach our $1.5 million goal before month-end.

It IS harder to hire technicians!

Last week, an NCPA survey asked if you were having trouble finding or recruiting pharmacy technicians. It seems the answer was a resounding “yes!”

The results:

“This is a major challenge for community pharmacies that are seeing many more patients because of the pandemic,” NCPA CEO Doug Hoey said. “Finding qualified workers is tough under normal circumstances. This is an acute problem for local pharmacies that should be at full strength now.”

MEDISCA Challenge update

Since Medisca offered to match individual contributions to APC’s cBHT Media campaign up to $100k last week (hint: click here to give), we have received $21,950 from individuals — meaning $43,900 with Medisca’s dollar-for-dollar match.

The challenge runs through the end of June, so now is the time to have your contribution doubled!

Compounder-requirement bill passes Calif assembly

California AB 1533, which would require the state’s board of pharmacy to have at least one representative from a compounding pharmacy, passed the California Assembly this week and now awaits action in the state senate. The legislation is supported by the California Pharmacists Association.

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