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APC News

APC Corporate Patron Briefing set for December 15

Published December 12, 2022

APC Corporate Patrons and other vendors associated with our organization are invited to attend a briefing on Thursday, December 15th at 11:00am ET.

Agenda items will include:

  • Year-end update on APC public policy priorities
  • Update on APC initiatives and projects
  • A look ahead to APC 2023 opportunities and initiatives

Here’s a calendar appointment that includes the Zoom link.

We appreciate your support for and interest in APC and hope you will join us on the 15th.

EduCon programming offers a buffet of learning options

Published December 12, 2022

Hold on to your toboggans, kids: APC’s EduCon is just over two months away.

APC’s annual virtual conference focuses on compounding’s best practices for keeping you and your team compliant and efficient.

Why do you need to attend EduCon 2023? Well, with up to 12 CE hours (approved for both pharmacists and technicians), EduCon is sure to be one of the best investments you can make in your professional development all year. Note: LIVE CE credit is only available on February 9 and 10. On-demand will be home study CE credit.

Here’s a taste of just three of the great sessions we’re offering:

The Compounders’ Code of Ethics and Your Commitment to Quality. Led by PCCA’s AJ Day, attendees will be asked to consider their answers to sticky questions centered around the Compounders’ Code of Ethics and the quality systems necessary to ensure your compounding pharmacy and team are in compliance.

Compounding for Thyroid the Right Way! Presented by Michelle Moser, Makers Compounding Pharmacy, this program will go deep into compounding specifics for your thyroid patients. Similar to following any recipe, compounding levothyroxine, liothyronine and thyroid USP requires attention to accuracy, dosage and potency.

Latest/Greatest Trends in Geriatrics and Hospice Compounding. Medisca’s Mindy Cormier will explore the growing need for compounding sterile and non-sterile preparations in geriatric and hospice applications, and how those treatments are used to help aging patients’ particular needs.

Best of all, to sweeten the EduCon value package, APC is offering early bird rates for members and PFMs. (For PFM technicians, the rate is only $99 until January 4!) Registration is open now, don’t miss out!

On amoxicillin compounding, APC urges—and FDA acts

Published December 12, 2022

At APC’s urging, FDA has released a final guidance document stipulating minimum steps pharmacies that compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

APC supported its plea to FDA with results of a survey showing the difficulty its members are facing in sourcing amoxicillin suspension.

Read more about the new guidance here.

Want to be influential at APC? Sign up for a 2023 committee seat

Published December 12, 2022

2023 is coming, and with it, new opportunities for you to serve and advance your profession. One of those opportunities is for you to lend your expertise as a member of a 2023 APC volunteer committee.

Committees are the workhorses of the Alliance, developing programming, chasing possibilities, and recommending policy to the APC Board of Directors. They are also a talent pool for recruiting future APC Board positions.

We’re seeking knowledgeable members for the following 2023 APC standing committees:

  • Communications
  • Education
  • Federal Legislative
  • Membership
  • State Legislative
  • Technician Services

If you would like to be considered for appointment, please send an email to info@a4pc.org, and include the following information:

  • Your name
  • Pharmacy/facility name
  • Town and state
  • APC committee(s) you’re interested in
  • A brief description of your expertise in the subject area covered by that committee

But don’t wait until the last minute! Committee requests are due to APC by COB December 20, 2022.

We urged, FDA acted

Published November 11, 2022

Agency issues guidance on beta lactam compounding in shortage

With amoxocillin suspension on FDA’s drug shortage list, on Friday the agency released a final guidance document stipulating minimum steps compounders who compound beta lactam oral antibiotic suspension products must take to mitigate the potential for cross-contamination with other products.

The steps include only compounding from FDA-approved beta-lactam tablets and capsules instead of bulk drug substances; use of dedicated or disposable equipment, utensils, and personal protective equipment; trituration of the FDA-approved product after wetting it with a quantity of the suspension vehicle sufficient to eliminate formation of product dust; and six other essential steps.

APC first alerted the agency three weeks ago that compounders’ ability to help mitigate the amoxicillin suspension shortage and get life-saving medicine to children in need was impeded by provisions in FDA’s Insanitary Conditions Guidance. That guidance requires compounders to “completely and comprehensively separate beta lactams from non-beta lactam products”—a provision with which many pharmacies, both hospital and retail, could not comply.

“Both hospital and retail pharmacies knew they had the ability to compound amoxicillin suspension from commercially available tablets or capsules,” said Scott Brunner, CAE, CEO of the Alliance for Pharmacy Compounding. “But they were unable to meet that requirement of complete and comprehensive separation from other products—and so they were concerned, rightly, about the potential for regulatory action to be taken against them for serving the need of their patients.”

The final guidance states:

“FDA’s insanitary conditions guidance describes the processing of beta-lactams without complete and comprehensive separation from non-beta-lactam products as an example of an insanitary condition the Agency has observed. However, during the time that beta-lactam antibiotic powder for oral suspension products are on the FDA shortage list … compounders under section 503A of the FD&C Act that prepare beta lactam oral antibiotic suspension products that appear on FDA’s shortage list without complete and comprehensive separation from non-beta-lactam products should take at least the following minimum steps to mitigate the potential risk of cross-contamination and reduce risk to patients.”

The guidance adds that the agency will “prioritize its regulatory and enforcement actions” if the nine prescribed steps “are not all followed when preparing beta-lactam oral antibiotic suspension products that appear on FDA’s shortage list.”

“This guidance is a remarkably rapid and helpful response from the agency, and I know compounders will take seriously their commitment to mitigate risks to get these medications to the children who need them,” said Brunner. “As with the help 503A compounders provided in sourcing shortage COVID drugs to hospitals under temporary FDA guidance back during the pandemic, this is another episode of ‘Compounders to the rescue!’”

As reported in a recent email message to APC members, FDA is interested in the data APC is gathering so that it can assess the scope of the problem. Please complete our amoxicillin survey.

Amoxicillin shortage: Can compounders help?

Published November 11, 2022

The start of cold and flu season has led to an immense spike in respiratory illness and also a shortage of amoxicillin oral suspension.

In the wake of the infant formula shortage, we must make sure we do everything we can to keep our pediatric patients healthy. We’d like to think compounders can help mitigate the problem, but we need your help.

Hospitals and some pharmacies would like to be able to compound amoxicillin suspension from the commercially available amoxicillin tablets or capsules. Trouble is, FDA’s Insanitary Conditions Guidance requires compounders to completely and comprehensively separate beta-lactams from non beta-lactam products, which many pharmacies, including those in hospitals, cannot accommodate.

APC has reached out to FDA about this concern and to ask the agency to consider temporary enforcement discretion that might allow 503A pharmacies to meet this current shortage need.

But we need some data to help quantify the scope of the problem, so we’ve launched a short survey of compounders. Please complete it ASAP so that we can share the result with FDA—and perhaps provide a solution that can save lives. The survey will only be open through Wednesday, November 23 at 8PM ET.

CLICK HERE TO TAKE THE SURVEY

APC testifies on Delaware proposal

Published November 11, 2022

APC Board Chair-Elect Anthony Grzib spoke on behalf of APC during the open comment period of the Delaware Board of Pharmacy meeting on Wednesday November 16. APC and NCPA submitted a comment letter to the Board of Pharmacy (BOP) regarding the proposal to add new subsection 5.1.7.3 to Section 2500 of the Delaware Administrative Code.

The letter recommends striking the current 10 percent limitation on 503A pharmacies providing office stock to veterinarians, as well as continuing to align state regulations with GFI #256 and any clarifications we may receive on the guidance. The BOP will discuss and vote on the proposed rule at their next meeting in January.

APC reported on this story earlier this month.

PCF announces 2023 leadership

Published November 11, 2022

Please join us in welcoming the Pharmacy Compounding Foundation’s 2023 Board of Directors.

Executive Officers
President: Stacy Hightower, Las Colinas Pharmacy, Aubrey, TX
President-elect: Jennifer Burch, Central Compounding, Durham, NC
Treasurer: Lloyd Levidow, Scottsdale, AZ

Directors
Michael Blaire, Wedgewood Pharmacy, Scottsdale, AZ
Liza Chapman, PTCB, Atlanta, GA
Barbara Exum, VCU School of Pharmacy, Glen Allen, VA
Greg Lake, Fagron, Hideout, UT
Katie Lewis, Pharmacy Solutions, Lincoln, NE
Robert Nickell, Nubratori RX, Torrance, CA

Ex officio, nonvoting
APC Chair: Anthony Grzib, Wedgewood Pharmacy, Swedesboro, NJ
APC CEO: Scott Brunner, Alexandria, VA

APC signs letter supporting antitrust bill

Published November 11, 2022

Earlier this week, APC and two dozen other independent business organizations signed a letter to Congressional leaders, urging them to prioritize an antitrust bill that targets tech giants during the lame-duck session.

The letter emphasized that passing the antitrust bill was crucial to the livelihood of small businesses: “Our members see little future…if the tech giants continue to corner the digital markets and use their power to favor their own products and block those of smaller rivals.”

December 8 webinar: How to leverage medical literature to support your compounded therapies

Published November 11, 2022

In a world of one-offs how do you develop a compounded treatment formula? It is essential to start with knowledge of the disease state, understanding the biology & pathophysiology involved and what are the pharmacologic therapeutic targets or goals.

The best place to obtain the most current knowledge on these topics is medical literature in both journal and text publications. The internet has brought the explosion of world’s scientific literature to our fingertips, but how do you decide what is fact from fiction or just bad science?

Speaker Nat Jones, RPh, FAPC, will show attendees how to identify and use medical research to help you better help your patients.

Webinar details

  • December 8, 2022
  • 2pm EST
  • $25 registration fee. Note: This webinar does not offer CE credit.

Click here to register.

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