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APC News

APC now accepts ACH payments

Published June 6, 2022

APC can now accept ACH (automated clearing house) transactions online through its MemberMax platform. Using this system avoids exposing your accounts to fraudulent activity and reduces the fee load that APC covers.

Next time you’re renewing your membership, moving to a Pharmacy/Facility Membership or paying your registration for Compounders on Capitol Hill 2022 (coming soon!), this system handles your transaction safely.

Click here for instructions on how to get set up for easy, breezy payment processing.

PCAC recommends glutathione for bulks list

Published June 6, 2022

FDA’s Pharmacy Compounding Advisory Committee this week voted to recommend that FDA add glutathione to the final 503A Bulks List, signaling that it can be compounded. The 8-5 vote, with one abstention, is not binding on FDA, however.

“As with methylcobalamin last year, the committee bucked the FDA staff’s recommendation against adding glutathione to the bulks list,” said APC’s Scott Brunner. “And just as with methylcobalamin, now we wait to see what formal action FDA may take on PCAC’s recommendation.”

Representing PCCA and NCPA, APC board member and PCCA Vice President of Clinical Services A.J. Day made a case to the committee for why the substance should be added to the bulks list.

“A.J. did a heroic job dismantling FDA’s inaccurate assessments of research that the agency referenced to argue against the addition of glutathione,” said Brunner, “And he did it under duress. While the FDA had a fairly unlimited time to present to the committee, A.J.’s presentation was limited, and he was cut off before completion.

He was forced to speak incredibly rapidly, yet still made a thorough case for why FDA was off base in its recommendation.”

“This is a win, thanks to A.J., and we’ll take it,” added Brunner. “But we simply must protest this PCAC process, from the insufficient time to review materials prior to the meeting to the limit of a 10-minute presentation per substance to the lack of any deliberation at all among committee members. We will raise it at next week’s compounding listening session with FDA for sure.”

In addition to glutathione, PCAC considered three additional substances for the 503A Bulks List in its meeting this week. The other three are ferric subsulfate, enclomiphene citrate, and ammonium tetrathiomolybdate. Only glutathione received the committee’s recommendation. PCAC also voted to add lorcaserin hydrochloride to the Withdrawn or Removed List, which affects 503A and 503B compounders.

APC Fellow nominations due June 30

Published June 6, 2022

Image courtesy of PIRO4D via Pixabay.com.

Think you have “the right stuff”?

The APC Fellows Program recognizes pharmacists and pharmacy technicians who are exemplary in their professionalism and commitment to the practice of pharmacy compounding.

Interested candidates must be registered pharmacists or pharmacy technicians who are APC members and who have practiced pharmacy for at least five years and practiced in the compounding pharmacy profession for at least three years.

The application deadline is June 30, 2022. Click here to learn more about the requirements and to submit an application.

APC Members are invited to show their pride in membership

Published June 6, 2022

APC Individual and Pharmacy/Facility Members (PFMs) can now display an APC logo on their websites, business cards and email signatures.

Not an APC member yet? Learn more about becoming one here.

For those who are, click on the appropriate link below, then complete, sign and return the logo usage agreement. Upon completion, we’ll send you the appropriate logo(s) so you can start showing your APC pride.

OneFund to unite them all

Published June 6, 2022

Here at APC, we do a lot with a little: we’re a small organization and our resources aren’t bottomless. But we’re scrappy, and when we tackle an issue, the results are usually good for your compounding practice.

APC’s OneFund is how we pay for our advocacy work. Right now—almost halfway into the year—OneFund has only raised 15% of its 2022 funding goal. That means our ability to keep doing what we’re doing is at risk.

If you believe what we’re doing benefits your patients or your profession or the pharmacy or facility you work for—please make a meaningful contribution to OneFund today.

Our newest PFM affinity service provider: Rx Advisors

Published June 6, 2022

Rx Advisors logoAPC Pharmacy/Facility Members (PFMs) are entitled to exceptional value opportunities through several hand-picked affinity service providers.

We’re pleased to introduce our newest one: Rx Advisors.

Rx Advisors is a full-service accounting and tax firm specializing in independent pharmacies, with specific expertise in compounding pharmacies.

Pharmacy/Facility Members only are eligible to receive a 20% discount on income tax, bookkeeping, payroll, and business advisory services.

Interested in learning more or taking advantage of RxAdvisor’s free income tax review. Well, first you have to become a PFM. If you’ve already made that smart move, contact Rx Advisors’ Curtis Cole at curtis@fleming-advisors.com or 855.877.9807.

APC’s Career Center is your new recruiting (and job-hunting) solution

Published June 6, 2022

Image courtesy of Amber McAuley on Pixabay.com

APC has launched a career website to help professionals and compounding pharmacies and facilities find each other quicker and easier.

Employers are invited to connect with our network of elite compounding professionals through our state-of-the-art recruitment platform.

Commercial job boards such as LinkedIn and ZipRecruiter cannot provide this level of targeted exposure. Employment advertising specialists are on hand to help you:

  • Develop strategic recruitment campaigns to place your employment brand in front of our elite talent pool
  • Build custom media packages for diversified exposure
  • Expedite real-time ads to help you get critical positions filled

To learn more, please visit our Employer home page.

For compounding pharmacy professionals looking for their next opportunity
APC’s Career Center provides access to the employers, job opportunities and job-hunting resources. Visit the Career Center Job Seeker home page to browse openings, upload your resume and set up job alerts.

APC’s OneFund helps us help you

Published June 6, 2022

Here at APC, we do a lot with a little: we’re a small organization and our resources aren’t bottomless. But we’re scrappy, and when we tackle an issue, the results are usually good for your compounding practice. 

Most recently, we’ve launched a portal to help our members aggregate patient-reported outcomes to prove to FDA that compounded medications are benefitting millions of patients. Via our Legal Action Fund, we’ve filed two recent amicus briefs in court cases, one defending your right to compound methylcobalamin and another addressing ambiguity in FDA’s insanitary conditions guidance.

We’re also:

  • Proposing to TRICARE a pilot project to demonstrate that compounded medications can help the agency achieve desired health outcomes and contain costs.
  • Talking with FDA about the practical flaws in its “final” GFI 256 on veterinary compounding—flaws that may impede animal healthcare.
  • Developing a “decision points document” to assist state boards of pharmacy in implementing and enforcing USP 800.
  • Proposing a DQSA fix that would eliminate the 25-year-old MOU, mandate reporting to state regulators by pharmacies that ship more than 50 percent of their compounded medications out of state, and create in law a narrow path for 503As to provide shortage drugs to hospitals and clinics.
  • Advocating to enable 503Bs to manufacture generics that have been off-patent for 20+ years, are on FDA’s essential drug list, and do not have a U.S.-based manufacturer. Our intent with this is threefold: address drug supply chain issues, stimulate stateside manufacturing, and strengthen the 503B business model.
  • Working with FDA and Congress to insist that compounding pharmacies’ 483 files be closed out within a more reasonable timeframe.
  • Providing our members an online payments platform that is integrated with the major compounding softwares.

But none of this stuff happens without funding—and right now, APC is running low on funds to support our advocacy work.

If you find the list above impressive—if you think the work we’re doing benefits your patients or your profession or the pharmacy or facility you work for—please click below:

OneFund banner

OneFund is supported by gifts from members like you. It’s how we pay for our advocacy work. Right now—almost halfway into the year—OneFund has only raised 15% of its 2022 funding goal. That means our ability to keep doing what we’re doing is at risk.

Please invest now, so we can keep watching out for you.

USP 800 work group aims to assist BOPs

Published May 5, 2022

A new APC workgroup is charged with developing guidance to help state boards of pharmacy interpret, implement and enforce USP 800. USP 800 provides guidelines for safe handling of hazardous drugs to minimize the risk of exposure for healthcare personnel, patients and the environment.

Chaired by Matt Martin, the group met for the first time this week to plan its work. The workgroup includes Cheri Kraemer; Jon Pritchett; Rad Dillon; John Herr; John Kim; Dave Rochefort; Kathleen Kane; and incoming APC Director of Public Policy Savannah Cunningham.

“We hope to provide boards of pharmacy thoughtful considerations about areas of USP 800 that have created significant discussion and/or concern for both pharmacists and some boards of pharmacy,” Martin said. “This USP chapter and its implementation will have a significant impact on patient access, the cost of healthcare and how healthcare is delivered across all disciplines of medicine based on how compliance is carried out. It is important that substantive discussions around the implementation of this chapter occur.”

The workgroup hopes to make its guidance resource available to boards of pharmacy in fall 2022.

APC amicus brief addresses ambiguity in FDA insanitary conditions guidance

Published May 5, 2022

Image of man signing legal document

Image by Leandro Aguilar from Pixabay.com

“Insanitary conditions” are whatever FDA says they are. This is neither legal nor fair.

That’s the gist of APC’s argument in a “friend of the court” brief filed in U.S. District Court in New Jersey on May 13.

Funded by member contributions to the APC’s Legal Action Fund, the amicus brief was authorized in response to an urgent request from Wedgewood Pharmacy that APC support its filing for a temporary restraining order against FDA.

Wedgewood filed its papers seeking a TRO on May 5, 2022, only after FDA demanded that Wedgewood immediately recall all nonsterile products within their expiry period, gave the pharmacy only 24 hours to respond, and failed to provide the pharmacy any information supporting the need for such an extraordinary, broad recall. Wedgewood told the court it suspected that, without the TRO, FDA would move quickly to publish a news release impugning Wedgewood based on FDA’s unsubstantiated findings of “insanitary conditions” at the pharmacy.

In the TRO filing, Wedgewood and its lawyers argued that FDA had inspected the pharmacy and issued eight observations in a Form 483 related to vague notions of insanitary conditions, which focused on areas well outside the pharmacy’s compounding areas. Wedgewood further stated that none of the observations listed on the Form 483 FDA violated applicable USP standards.

APC’s amicus brief, approved by the Executive Committee*, focused solely on the lack of standards in FDA’s Insanitary Conditions GFI and FDA’s failure to promulgate any enforceable rules concerning the same.

APC engaged in the matter because we were—and remain—concerned about the significant implications on other APC-member compounding pharmacies if FDA continues to impose what appears to be the vague, subjective disciplinary standard suffered by Wedgewood. In particular, FDA derives its enforcement authority from a non-binding guidance document that contains not any objective standards, but instead relies on what appears to be a bunch of examples and the nebulous statement that “other conditions not described in the guidance may also be considered unsanitary.” How is a compounder to know what is in fact violative conduct?

In that vein, we argue in the amicus that a pharmacy “would have no basis to know under the plain meaning of the term ‘insanitary conditions’ or under the explanation set forth in the Insanitary Conditions Guidance that ‘observed personnel who moved rapidly in a sterile compounding area’ or who ‘was noted to have their safety glasses down on their nose’ would meet the standard for insanitary conditions.” Both of those were among FDA’s Form 483 observations against Wedgewood.

Last week the District Court denied Wedgewood’s request for a TRO. The judge said she could not issue a restraining order on an action that had not yet occurred—in this case, FDA’s publishing of a damning press release. But during oral argument, she also made clear that she expected FDA to work with Wedgewood to settle their difference and seemed to suggest she wanted that to occur without FDA publishing a news release that could unnecessarily damage Wedgewood’s reputation based on unsubstantiated or exaggerated claims of “insanitary conditions.”

While APC strongly supports the maintenance of sanitary workspaces where compounded drugs are prepared—it’s simply essential for assuring patient safety—there must be standards for what constitute “insanitary conditions,” and those standards need to be rooted in science and the law. Our amicus brief in this matter is the clearest elucidation of the flaws in FDA’s Insanitary Condition Guidance I’ve seen. I do urge you to read it.

APC is proud of our involvement in this matter. Just another way we’re looking out for you.

By the way, if you’d like to fuel our ability to be involved in other legal cases related to pharmacy compounding, please give to APC’s Legal Action Fund.

* Two Wedgewood employees who are members of APC’s Executive Committee recused themselves entirely from the deliberation and voting on the funding request.

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