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APC News

Two proposed state regs changes to be aware of

Published October 10, 2022

Kentucky’s “licensure lite” proposal
Kentucky BOP has proposed a change for non-resident pharmacist licensing. The proposal would create a new non-resident pharmacist license for pharmacists located in other states. The new individual licensure category would exist alongside and in addition to existing non-resident pharmacy permit requirements. Applicants would not have to submit to license transfer requirements or pass the Multistate Pharmacy Jurisprudence Examination. The Board-approved amendment will be open for public comment shortly.

It’s worth noting that Kentucky’s proposal is similar to the current Nevada requirement that requires any pharmacist engaged in the practice of compounding or dispensing prescription drugs for patients in Nevada to pay a $250 annual registration fee to Nevada and to be subject to state oversight. The Nevada requirement goes beyond simply requiring a pharmacist-in-charge to register with the board and applies to all pharmacists engaged in compounding or dispensing activities for patients in Nevada.

Arkansas animal compounding office-use rule change
Arkansas BOP has proposed a rule change that will allow pharmacists in a both 503A and 503B facilities to compound office-use products for veterinarians as allowed under new FDA Guidance.

You may submit comments to Arkansas State Board of Pharmacy, 322 South Main Street, Suite 600, Little Rock, AR 72201, or email asbp@arkansas.gov

The threat to compounded hormones just got real

Published September 9, 2022

FDA has declared desiccated thyroid extract (DTE) to be a biologic drug and therefore ineligible for compounding.

In a September 16 letter to National Association of Boards of Pharmacy CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.”

The letter encourages NABP to share the letter with its members, the state boards of pharmacy, which Carter did in a memo to boards of pharmacy on September 22.

“This is a baffling move by FDA, both the substance of their categorization of DTE as a biologic and the back-door path they’ve taken in declaring it so,” said APC CEO Scott Brunner. “The letter to NABP comes not from FDA CDER leadership but from a branch chief in that division, and no public communication or announcement by FDA has yet been issued.”

“Can state boards of pharmacy be expected to use the letter to cite or otherwise restrict 503A compounding pharmacies that compound with DTE?” Brunner asked.

“We are concerned that states may do just that, but at this time, with so little information, we do not know the approach boards may take on DTE, especially given the significant patient access issues to this important medication that such state action will create.”

“FDA says in the letter that it considers thyroid USP to be a biologic on the basis of a component in the product, thyroglobulin, that is not even an active ingredient of the medication,” said APC President Dave Miller. “Yet neither thyroid USP nor thyroglobulin are listed in FDA’s Purple Book. In addition, the commercially available thyroid USP drug products make no mention of thyroglobulin on their products’ inserts or labeling. If thyroglobulin may cause the patient harm FDA says it does, why is it not even mentioned on those inserts or labels?”

Brunner has reached out to FDA OCQC Director Gail Bormel to request an immediate meeting about the letter and apparent reclassification.

“If you’ve been looking for evidence that FDA aims to restrict hormone compounding, you have to view this as the first real shot fired,” said Brunner. “Now it’s all the more important that we get the funding we need to engage patients and members of Congress—and likely lawyers, too—to push back against this overreach by the agency.”

Want to help? Start by taking our four-question survey

APC has created a preliminary briefing document on this issue and has scheduled an October 13 Town Hall for members. See below for details on that event.

You may also want to share the briefing document with your state board of pharmacy, so they’ll be aware of our concerns about patient access.

In addition, we have created a very brief survey aimed at helping us quantify the effects of thyroid USP compounding. Please complete the survey at your first opportunity:

Take Our Thyroid USP Survey

“After we know more from FDA about this action they’ve taken, APC will likely issue a call to action to our members and patients urging them to reach out to Congress and FDA,” said Miller. “Stay tuned, and be ready to respond.”

 

October 6 stakeholder briefing on measuring patient outcomes

Published September 9, 2022

If patient-reported outcomes can prove your value, why aren’t more of you collecting them?

They say you can’t prove what you don’t measure. That’s certainly true when it comes to the compounds you prepare.

The best tool you have for demonstrating the value of your therapies is your patients—what they say about the compounded medications you dispense to them. But many compounders aren’t measuring patient outcomes, and those who are aren’t doing so in formats that can be aggregated in a way the FDA will find compelling.

Earlier this year, APC announced a collaboration with OutcomeMD, a platform that allows compounding pharmacies to measure patient-reported outcomes (PROs) using the same validated measures that FDA requires in new drug approvals.

Despite that hoopla, the uptake on the program thus far has been lackluster, and that’s a problem—because the future of 503A compounding depends in large part on your ability to measure outcomes that demonstrate your value.

On October 6, we’re hosting a PRO Stakeholder Briefing. If you are an owner or pharmacy manager, you owe it to your business to attend, to learn about our enhancements to the platform, the compounding softwares it now integrates with, and to hear from one of our APC members who has embraced the OutcomeMD platform and whose practice in Philadelphia is better for it. We promise you: No sales pitches, but some good info, and a chance for you to ask questions and make suggestions.

 

FDA uses back door to restrict DTE compounding

Published September 9, 2022

FDA has declared desiccated thyroid extract (DTE) to be a biologic drug and therefore ineligible for compounding.

In a September 16 letter to National Association of Boards of Pharmacy CEO Al Carter, FDA states that DTE products “can put patients at harm” and that “therapies containing DTE are biological products subject to licensure under Section 351(i) of the PHS Act.”

The letter encourages NABP to share the letter with its members, the state boards of pharmacy, which Carter did in a memo to boards of pharmacy on September 22.

“This is a baffling move by FDA, both the substance of their categorization of DTE as a biologic and the back-door path they’ve taken in declaring it so,” said APC CEO Scott Brunner. “The letter to NABP comes not from FDA CDER leadership but from a branch chief in that division, and no public communication or announcement by FDA has yet been issued.”

“Can state boards of pharmacy be expected to use the letter to cite or otherwise restrict 503A compounding pharmacies that compound with DTE?” Brunner asked.

“We are concerned that states may do just that, but at this time, with so little information, we do not know the approach boards may take on DTE, especially given the significant patient access issues to this important medication that such state action will create.”

“FDA says in the letter that it considers thyroid USP to be a biologic on the basis of a component in the product, thyroglobulin, that is not even an active ingredient of the medication,” said APC President Dave Miller. “Yet neither thyroid USP nor thyroglobulin are listed in FDA’s Purple Book. In addition, the commercially available thyroid USP drug products make no mention of thyroglobulin on their products’ inserts or labeling. If thyroglobulin may cause the patient harm FDA says it does, why is it not even mentioned on those inserts or labels?”

Brunner has reached out to FDA OCQC Director Gail Bormel to request an immediate meeting about the letter and apparent reclassification.

“If you’ve been looking for evidence that FDA aims to restrict hormone compounding, you have to view this as the first real shot fired,” said Brunner. “Now it’s all the more important that we get the funding we need to engage patients and members of Congress—and likely lawyers, too—to push back against this overreach by the agency.”

Want to help? Start by taking our four-question survey

APC has created a preliminary briefing document on this issue and has scheduled an October 13 Town Hall for members. See below for details on that event.

You may also want to share the briefing document with your state board of pharmacy, so they’ll be aware of our concerns about patient access.

In addition, we have created a very brief survey aimed at helping us quantify the effects of thyroid USP compounding. Please complete the survey at your first opportunity:

Take Our Thyroid USP Survey

“After we know more from FDA about this action they’ve taken, APC will likely issue a call to action to our members and patients urging them to reach out to Congress and FDA,” said Miller. “Stay tuned, and be ready to respond.”

 

IMPORTANT STAKEHOLDER BRIEFING: Measuring Patient Outcomes

Published September 9, 2022

If patient-reported outcomes can prove your value, why aren’t more of you collecting them?

They say you can’t prove what you don’t measure. That’s certainly true when it comes to the compounds you prepare.

The best tool you have for demonstrating the value of your therapies is your patients—what they say about the compounded medications you dispense to them. But many compounders aren’t measuring patient outcomes, and those who are aren’t doing so in formats that can be aggregated in a way the FDA will find compelling.

Earlier this year, APC announced a collaboration with OutcomeMD, a platform that allows compounding pharmacies to measure patient-reported outcomes (PROs) using the same validated measures that FDA requires in new drug approvals.

Despite that hoopla, the uptake on the program thus far has been lackluster, and that’s a problem—because the future of 503A compounding depends in large part on your ability to measure outcomes that demonstrate your value.

On October 6, we’re hosting a PRO Stakeholder Briefing. If you are an owner or pharmacy manager, you owe it to your business to attend, to learn about our enhancements to the platform, the compounding softwares it now integrates with, and to hear from one of our APC members who has embraced the OutcomeMD platform and whose practice in Philadelphia is better for it. We promise you: No sales pitches, but some good info, and a chance for you to ask questions and make suggestions.

The meeting is FREE, but registration is required: a4pc.org/PROStakeholderBriefing

https://us02web.zoom.us/meeting/register/tZwtduitrjsqGtEfWdCdfY3j72STGdbbwCH-

URGENT: Deadline for joint Congressional letter on GFI 256 is September 30

Published September 9, 2022

One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding.

The bipartisan letter is anchored by Congressmen Mark Pocan (D-WI) and John Carter (R-TX).

Here’s how you can help:

  • Via the link below, please contact your Congressperson and urge them to sign on to this joint letter to CVM on GFI 256.
  • As you’ll read in the message at the link below, they’ll need to contact Penny Stehlik in Rep. Carter’s office at Penny.Stehlik@mail.house.gov to sign on to the letter.

The letter closes September 30, so time is short.

By signing this letter, your Congresspeople are helping to ensure veterinarians and animal patients continue to have access to the compounded medications they need.

One more thing: If you know your US House member personally, call, text or email them directly about this IN ADDITION to sending the message via our portal below.

Remember, the deadline to sign is Friday, September 30, 2022.

CLICK HERE TO SEND A MESSAGE TO YOUR CONGRESSPERSON.

Push back against TRICARE network exclusion

Published September 9, 2022

Express Scripts (ESI) has slashed pharmacy reimbursements for 2023, making it impossible for many independent community pharmacies to participate in the TRICARE pharmacy network.

ESI has also notified TRICARE beneficiaries that their pharmacy will no longer be in network as of October 24, 2022, instead of the end of December this year. ESI’s actions are creating disruptions for TRICARE beneficiaries and their caregivers, and making it more difficult for many to access their necessary prescriptions.

If you would like to take action, NCPA and APC are encouraging pharmacists to use this link to urge your federal legislators to sign on to a letter led by Sen. Tom Cotton (R-Ark.) and Rep. Buddy Carter (R-Ga.) that demands answers from the Department of Defense on the recent TRICARE pharmacy contracts. Don’t delay, as the deadline for Members of Congress to sign on is September 28.

For your patients and their caregivers who are experiencing a disruption, please direct them to this NCPA-created resource to take action. Print this letter in your pharmacy and ask your affected patients to sign and mail directly to the Defense Health Agency.

For PFMs: Protection from legal exposure

Published September 9, 2022

What if APC gave you a tool that would:

  • Meet state and accreditation requirements that you have a continuous quality improvement program?
  • Allow you to track and learn from your patient safety data without fear of legal exposure?
  • Protect the med safety risk mitigation work you do from blanket requests for safety data?

What would that be worth to you?

The good news is, you already have such a tool through APC’s Pharmacy/Facility Membership (PFM). In addition to several other exclusive benefits, PFMs get free membership in the Alliance for Patient Medication Safety, a PSO that provides you those protections.

But first you must become a PFM. Click here or contact Jason Dunn at jason@a4pc.org to learn more about these and the many other benefits that come with being a PFM.

URGENT CALL TO ACTION: Ask your U.S. Representative to sign this joint Congressional letter on GFI 256!

Published September 9, 2022

One result of last week’s Compounders on Capitol Hill visits has been the creation of a joint congressional letter to FDA’s Center for Veterinary Medicine raising concerns about the great ambiguity in GFI 256 on animal compounding.

The bipartisan letter is anchored by Congressmen Mark Pocan (D-WI) and John Carter (R-TX).

Via the link below, please contact your Congressperson and urge them to sign on to this joint letter to CVM on GFI 256. As you’ll read in the message at the link below, they’ll need to contact Penny Stehlik in Rep. Carter’s office at Penny.Stehlik@mail.house.gov to sign on to the letter. The letter closes September 30, so time is short.

In doing so, they are helping ensure veterinarians and animal patients continue to have access to the compounded medications they rely on.

One more thing: If you know your U.S. House member personally, call, text or email them directly about this—IN ADDITION to sending the message via our portal below.

CLICK HERE TO SEND A MESSAGE TO YOUR CONGRESSPERSON

A.J. Day receives APC’s Malmberg Award

Published September 9, 2022

From left: AJ Day, 2022 George + Lucy Malmberg Award Recipient, and Michael Blaire, Chair, APC Board of Directors.

A.J. Day, vice president of clinical services at PCCA, and an APC Board member, was named APC’s 2022 George and Lucy Malmberg Compounding Advocacy Champion during Compounders on Capitol Hill.

A.J. received the award for two prominent, very positive, and very productive accomplishments he achieved on behalf of the profession: 

  • His powerful testimony in support of glutathione at the FDA PCAC meeting in June 2022, where he testified under duress, having to speak rapidly and amid interruptions. Despite these challenges, his testimony was factual and compelling, and it voted in a positive vote for glutathione.
  • Leading in assessing clinical research on compounded hormone therapy, which resulted in an important article in the journal Menopause in April of this year. 

The award was presented by APC Board Chair Michael Blaire.

Congratulations, A.J., on this much deserved recognition!

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