From APC's President

Don’t just sit there.

DO something!

There have been times in my life when I’ve wished that old adage was “Don’t just do something, sit there!” Maybe you have, too. Sitting there is always the easier response—and when circumstances need contemplating, it may even be the better response.

But here and now, as it relates to your compounding job … business … teammates … patients … future, sitting there is precisely what NOT to do.

Below you’ll read that we’ve designated Thursday, September 15—the same day about 150 of your fellow compounding professionals will be going to Capitol Hill in Washington, DC to meet with our members of Congress—as Compounding Advocacy Day. If you’re unable to join us for Compounders on Capitol Hill on that day, we’re asking you to do something. And what we’re asking is not difficult or time-consuming: Simply post some messages on your social media and send a message to your members of Congress—and urge your teammates to do the same.

It's how we can multiply the effects of our Capitol Hill advocacy. It’s how to have our message heard more loudly and clearly.

More details will be coming soon. For now, mark September 15 on your calendar and alert your teammates. APC will provide you the exact messaging to post and send. We’ll make it easy for you to do your part, for you to do something.

Because with all the threats our profession is facing, this is no time to just sit there.

• • •

David Miller is APC’s president and the managing co-owner of Keystone Compounding Pharmacy in Grand Rapids, Michigan. You can reach him at drdave@keystonepharm.com.

This week

YOUR TWO-WEEK WARNING + TWO ASKS

September 15 is Compounding Advocacy Day, and you have two ways to participate…

Way #1: 

Join us for APC’s Compounders on Capitol Hill—the day when compounders come to DC to meet with their members of Congress. It’s September 14-15—

only two weeks away.

There’s still time to register and join more than 130 of your fellow compounding professionals to advocate face-to-face with policymakers on issues impacting your patients and practice. The 18 hours or so you’ll spend in our nation’s capital can make all the difference in how compounding is treated in law and by FDA. 

But you need to act quickly so we can get your appointments scheduled with your members of Congress. Here’s where to register:

If you cannot attend CCH in person, here’s the next best thing…

Way #2: 

We’re declaring that Thursday, September 15—the same day as our Congressional visits in DC—is Compounding Advocacy Day across America. Even if you’re unable to attend CCH, you and your team members can advocate from afar.

On September 15, we’re asking you to do a couple of things, and we’re going to make it really easy for you by providing the messaging (coming soon):

1) Throughout the day, post our four pre-drafted messages on your PERSONAL and PHARMACY social media accounts. We’re talking Twitter, Facebook, LinkedIn and Instagram. On Twitter, be sure and tag your members of Congress (all three of them: two U.S. Senators, one U.S. Representative).

2) Send a customized message to your members of Congress, urging them to take action on the three priority issues we’re focused on:

• Preserving patient access to compounded hormone therapy.
• Requesting clarity—and an enforcement extension—in FDA’s GFI 256, regarding animal compounding.
• Authorizing compounders to help fill supply chain gaps when essential drugs are in shortage.

More details are coming soon. For now, circle September 15 on your calendar, alert your teammates, and plan to participate!

Meet our newest PFM benefit:

Shipment Trackers

In a 2021 survey, 62% of compounding pharmacy owners told us that the high cost of shipping was a significant pain point for their businesses.

The good news is, Shipment Trackers, APC's newest Pharmacy/Facility Member (PFM) affinity service provider, offers preferred pricing on these services to PFMs:

• Audits: Review UPS and FedEx audits for late delivery credits (average savings range from 10 - 15 percent)
• Parcel insurance: Industry leading parcel insurance, including insurance coverage against spoilage and extreme temperature events
• Carrier contract and consultation audits to get you the best rates with your preferred carrier
• Business intelligence and analytics allow you to maximize your strengths and identify areas for improvement

If you're not already a PFM and would like to change that, please click here for details or you can contact APC’s Jason Dunn at jason@a4pc.org or 918.770.6333.

Surveys say: Vets and Compounders aren’t ready for GFI 256

In an APC member survey conducted last month, 59 percent of compounders said they were not aware that FDA’s Guidance for Industry #256, Compounding Animal Drugs from Bulk Drug Substances, is slated to be enforced beginning October 1, 2022.

Only 54 percent of respondents said they knew the guidance had been finalized back in April.

Not only that, but a new nationwide poll of veterinary practices conducted by Wedgewood Pharmacy shows that 69% of veterinary practices are not confident they are prepared to comply with provisions of that guidance document.

“These survey results give credence to our request that FDA’s Center for Veterinary Medicine delay enforcement of the GFI until October 2024,” said APC CEO Scott Brunner, CAE. “Not only is awareness of the GFI low among those to whom it applies, but we don’t even have clarity from the agency yet on what compliance looks like. To begin enforcement under these conditions makes no sense. CVM needs to slow down and work with stakeholders to get this right.”

In the APC member survey, 83 percent of respondents said they had not developed policies and procedures for documenting a veterinarian’s clinical rationale for a compounded medication and 82 percent said they had not developed policies and procedures for reporting adverse events. Both are required under the GFI. Only nine percent of respondents indicated high confidence that their compounding practice would be prepared to comply with the provisions of the GFI by the stated October 1 enforcement date. 

Not-ready-for-GFI 256 dog image by Myléne from Pixabay.

Save these dates

TODAY, September 2 at NOON ET: A free APC informational webinar, How GFI 256 will change your compounding operation

September 6–8: FDA's virtual Compounding Quality Center of Excellence Annual Conference

September 14: APC's Annual Meeting during Compounders on Capitol Hill, 2:00-2:30pm ET, Hilton National Mall, Washington, DC

September 14–15: APC’s Compounders on Capitol Hill 2022, Hilton National Mall, Washington, DC

September 22: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART I - PROVIDERS AND PRESCRIPTIONS

October 13: An APC Webinar: Keeping it Legit: Best Authentication Practices for Compounders, PART II - WHOLESALE DISTRIBUTORS (registration link coming soon)

October 26–29: PCCA's International Seminar, Houston, TX (in-person + virtual)

Short takes

California pharmacy hosts congressman. Early last month, APC member San Ysidro Pharmacy welcomed Congressman Salud Carbajal for a visit. According to owner Lara Edington Hove, it went very well. Click on these links to see local TV news and print media coverage.

Family Savvy podcast focuses on compounded hormones. PCCA's Lizzie Harbin and Sara Hoover spoke recently with lifestyle blogger Jamie Tarence to discuss the threat to compounded hormones.

Calories consumed during CCH don't count. Here's another sweet incentive to attend next month's Compounders on Capitol Hill: DC is home to Georgetown Cupcakes, the bakery featured on TLC's reality show, DC Cupcakes.

Quick links



APC Career Center

• Job seekers

• Employers

APC's Code of Ethics

Compounding Connections archive

Compounders on Capitol Hill 2022

Continuing education

• Live webinars

• On-demand webinars

Current issues:

• GFI #256 on animal compounding

• Urgent-use compounding

• Prohibition on peptide compounding

• La Vita Case amicus filing

• Insanitary Conditions amicus filing

Prescriber Briefing Resources

Invest in APC efforts

• CompPAC

• Campaign to save cBHT

• OneFund

Membership

• Renew

• Pharmacy/Facility Membership (PFM)

• APC Logo agreement for PFMs

• APC Logo agreement for individual members

Affinity service providers

• Accounting & Tax Services: Rx Advisors

• Audible Sunshine

• Office Equipment: TUI Solutions

• Online Payments Platform: HealNow

• Patient-Reported Outcomes: OutcomeMD

• Shipment Trackers, a shipping costs auditor

APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to info@a4pc.org.