APC News

Strategic sessions: An Owner Summit recap

Published April 4, 2024

We kept most of our Owner Summit sessions short and sweet, but some of our Saturday topics were too meaty to cover in 30 minutes. Here’s a quick roundup of three sessions:


Compounding Cases: A Survey of Legal Action By and Against Compounding Pharmacies

A timely Owner Summit session this weekend included a survey on Legal Action by and against compounding pharmacies by Fagron’s Jay McEniry. Jay covered the following cases:

  • Athenex v. Azar
  • Allergan v. Sincerus
  • Nexus v. [Everybody] 
  • Hope v. Fagron
  • SCA Pharmaceuticals v. FDA
  • Absolute Pharmacy v. California BOP
  • Evexias Health Solutions v. FDA

The rulings in these cases will have serious implications on compounding practice today, covering legal issues such as the concept of implied preemption (whereby only the FDA has the right to enforce the FDCA), the appropriate regulatory procedures for Section 705(b) Notices, and the requirement of a state to have a basis in their state law before enforcing federal laws. Here are his slides with more details on the cases.  


Best Practice for Ketamine Compounding

Panelists Jack Korbutov, Peter Koshland, and Gina Besteman, all pharmacists experienced in dispensing compounded ketamine, discussed techniques to avoid diversion of the controlled substance, typical dosage and formulation bioavailability considerations, and typical “red flags” with prescribers and prescriptions.They also touched on documentation best practices, pharmacist corresponding responsibility, and favorite flavors. (One more time: Here’s the ketamine best practices document.)


How FDA Thinks

In this final Owner Summit session, Hyman, Phelps & McNamara attorneys Dara Levy and Karla Palmer discussed how FDA thinks about its bulks lists nominations, reviews, and claims and substantiation.They discussed the history of the 503A bulks list, the most recent update to the list made in September 2023, legal challenges to the list, and the various levels of evidence for substantiating claims about prescription drugs. You can find their slides here.

Free money for students and technicians

Published April 4, 2024

Thanks to Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation is offering up to two $2,500 scholarships to pharmacy students who have demonstrated commitment to a career in compounding pharmacy in the United States.

All applications must be submitted by THIS MONDAY, April 15 at 11:59pm ET. All applicants must read and comply with all official rules, found at a4pc.org/scholarships.

In addition, the Pharmacy Compounding Foundation is awarding up to 10 pharmacy technicians a grant valued of up to $495 to complete APC’s online 15-hour curriculum, The Ethical, Legal, and Regulatory Foundations of Pharmacy Compounding. All applications must be submitted by June 30 and can be found here

New ‘best practices’ + constructive transfer and peptides

Published April 4, 2024

Last week in a special edition of Compounding Connections, we shared a handful of new information and practice resources approved by the APC Board of Directors. 

It’s important for you to be aware of them, so we’re sharing again here. Take a look and incorporate them into your compounding SOPs.

You can find all four on our homepage at a4pc.org as well.

Let’s get this over with

Published April 4, 2024

Me again, asking you for money. I do this a lot – too much, really – but the alternative is an underfunded APC that can’t protect your job, pharmacy, and patients.

So I’ve got a deal for you, and if you say yes, this could very possibly be the last time this year I’m going to ask you for money.

Seriously: Your response to this ask could rid your email box for the rest of this year of our regular solicitations for …

  • OneFund, which fuels our lobbying work.
  • The Legal Action Fund, which allows us to engage in legal cases affecting compounding.
  • Our Compounding the Joy of Living Campaign, including our work to save compounded hormones, engage prescribers, and expand compounding.com.
  • The Pharmacy Compounding Foundation, which makes grants and investments to help assure compounding’s future.

Just imagine all those emails you won’t have to wade through!

Last week at Owner Summit, we rolled out new APC Package Deals – whereby you make one annual investment to support all four of those initiatives mentioned above.

It’s an efficient way for you both to fund our work and have some peace – as in, a break from our solicitation emails, but also the peace of mind that comes from doing your part for your profession.

I don’t like asking for money any more than you like being asked (and asked and asked and asked). So let’s get this over with.

Click below to take a look at our Package Deals, make your one-time investment, and help us continue to do what we do for you.

Invest ONCE in APC

— Scott

Scott Brunner, CAE, is APC’s chief executive officer. You can reach him at scott@a4pc.org.

Just in time for ketamine: APC updates Constructive Transfer statement

Published April 4, 2024

APC’s Board this week approved minor revisions to its policy statement on Constructive Transfer of compounded controlled substance drugs. The statement was first adopted in 2010.  The new revisions provide pharmacy compounders with an updated briefing, highlighting the DEA’s recent limited enforcement actions regarding the constructive transfer of controlled substances to physicians. The statement also reiterates the position the DEA has taken regarding pharmacists and their obligations outlined in the federal Controlled Substances Act. 

“The provided information aims to support pharmacists in making informed decisions regarding the delivery of controlled substances to prescribers for in-office administration, including certain dosage forms of ketamine,” said APC’s Tenille Davis.

New ‘Primer on Compounding Accreditations’ released

Published April 4, 2024

APC is releasing to its Pharmacy/Facility Members this week a Primer on Compounding Accreditations (PFM login and password required) to assist them in determining accreditations they may wish to pursue.

“Researching the various accreditations can be a real chore for pharmacy owners or their staff,” said APC’s Chief Advocacy Officer Tenille Davis. “With this document, we’re trying to make that process just a little easier for them, so they can see at a glance what each of a number of possible accreditations does and the circumstances in which having a particular one might be helpful.”

Board approves ketamine and office-pay best practices docs

Published April 4, 2024

APC’s Board of Directors has authorized two “best practices” documents aimed at helping APC members practice with utmost care and consistency. 

Developed by a working group comprised of APC member experts, the documents are: 

“These best practices flow from APC’s mission to elevate the practice of pharmacy compounding,” said APC Board Chair Joe Navarra. “They’ll guide our members in practicing with the highest ethics and integrity — all in the interest of ensuring patients get the compounded medications they need and that those medications are of highest quality.”

Pharmacist and APC Board Vice President Gina Besteman of Women’s International, who chaired the work group that proposed the documents, sees them as compliance checklists that pharmacies can post and pharmacy team members can reference. “Most of these best practices are just good common sense. What we’ve tried to do is collect and organize them in a way that can help compounding pharmacies think carefully about what they’re doing when they prepare ketamine or enter into a relationship with a clinic for direct billing.”

The ketamine best practices document makes clear APC’s stance on compounding the drug: “The Alliance for Pharmacy Compounding supports the responsible compounding and dispensing of ketamine products by pharmacies pursuant to a prescription,” it reads. The document covers: 

  • Pharmacist Legal Obligations
  • Diversion Concerns
  • Dosing Limits
  • Dosage Forms
  • Documentation
  • Patient Education
  • Constructive Transfer
  • Ketamine Onboarding Checklist for 503B Wholesaling

“The Office Pay best practices were developed in response to action by some state boards of pharmacy to cite compounders for a practice that is perfectly legal in most states when done correctly,” said APC’s CEO Scott Brunner. “We believe some inspectors were misinformed about the practice, but we also see an opportunity to enunciate for our members the proper steps they should consider when doing clinic direct billing.”

APC “developed this ‘best practices’ guidance regarding billing of patient-specific compounded medications directly to a provider’s office to assist compounding pharmacies in complying with federal and state laws,” the document reads. It goes on to cover: 

  • Obtaining a signed physician/prescriber attestation that they understand the particulars of the arrangement
  • Verifying the patient-prescriber relationship
  • Adherence to applicable laws and regulations, both federal and state.
  • Veterinary clinic billing considerations 
  • Marketing
  • Knowing the prescriber and their limitations

APC also will be sharing the documents with boards of pharmacy, other policymakers and stakeholders, and news media.

California requires med errors reporting … eventually

Published April 4, 2024

Community pharmacies — defined as any pharmacy that dispenses medication to an outpatient, including both resident and nonresident pharmacies — are now required to report medication errors in California. 

In the new law, a medication error includes any variation from a prescription drug order not authorized by the prescriber, including errors involving the wrong drug, dose, patient, directions, preparation, and/or route of administration. Errors that are corrected prior to dispensing are not required to be reported. The law provides that such reports are confidential and not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act. The CA board is authorized to publish certain de-identified information compiled from the data in the reports in accordance with specified requirements.

The law went into effect January 1, but the California Board of Pharmacy is delaying enforcement until they identify a vendor to receive the medication error reports.  

As an aside, remember that APC PFM member dues include membership in APMS, a patient safety organization that helps pharmacies report and learn from medication errors.

Call for compounding scholarship applications

Published April 4, 2024

Through the generosity of Pharmacists Mutual Insurance Company, the Pharmacy Compounding Foundation is offering up to two (2) pharmacy students a scholarship valued at $2,500.

All applications must be submitted by April 15, 2024 at 11:59pm ET. All applicants must read and comply with all official rules, found at a4pc.org/scholarships.

Applicants will be notified of results by May 15, 2024. Scholarship winners will be announced to the public via pre-recorded video during APC’s Compounders on Capitol Hill in September 2024.

Contact the Pharmacy Compounding Foundation at foundation@a4pc.org with any questions.


Input needed: FDA’s demonstrably difficult rule

Published April 4, 2024

As we reported last week, a proposed FDA rule, Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A and 503B of the Federal Food Drug and Cosmetic Act, has been published in the Federal Register.   

In previous comments, APC and others raised procedural concerns with FDA proposing categories of drugs for the list prior to the criteria for evaluation being finalized. The criteria that the FDA has proposed for determining if a compound presents demonstrable difficulties for a pharmacy to prepare are: the formulation complexity, drug delivery mechanism complexity, dosage form complexity, complexity of achieving or assessing bioavailability, compounding process complexity, and complexity of physicochemical or analytical testing of the drug product or category of drug products. FDA has indicated that it intends to consider these criteria individually and collectively, and to take into account the risks and benefits to patients of the compounded drug product or categories of drug products. 

Before APC determines its position and prepares comments to FDA on the proposed rule, we want to hear from you. Do you compound solid modified-release drug products that employ coated systems, liposome drug products, or drug products produced using hot melt extrusion? (Yes/No) We hope to ascertain if these products/processes being added to the DDC list will affect our members and your ability to serve patients..Additionally, please share input on any other comments you might want APC to include in its letter to FDA. Just email tenille@a4pc.org

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