It’s been a week of mixed messages from FDA regarding pharmacy compounding.
On Monday, HHS and FDA delivered technical assistance comments to the House Energy & Commerce Committee about HR 3662, the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021, supported by APC.
Despite the fact that much in the legislation mirrors FDA’s own pandemic-timed temporary guidance, they don’t much like the bill: “FDA would have significant concerns if section 503A of the Federal Food, Drug, and Cosmetic Act were amended to allow for compounding, distribution, or dispensing of drug products before the receipt of a valid prescription order or notation for an identified individual patient under the conditions described in the proposed Act.”
Okay, now hold that thought for a sec.
On Wednesday, FDA released revised draft guidance for health systems that describes “certain circumstances under which FDA generally would not intend to take action if a hospital or health system pharmacy distributed compounded drug products without first receiving a patient-specific prescription or order.” The revision removes the one-mile radius provision contained in an earlier draft guidance, which would have allowed a hospital compounding facility to distribute a compounded drug to a hospital-affiliated facility withing a one-mile radius.
“There is baffling inconsistency between these two FDA stances,” said APC CEO Scott Brunner, CAE. “And it’s multi-layered inconsistency. First, FDA is telling Congress it opposes something the agency is presently allowing: The ability of 503A compounding pharmacies to prepare shortage drugs for hospitals when the drugs cannot be sourced from manufacturers of 503B facilities. Second, FDA bases its opposition largely on concerns about such distributions without prior receipt of a valid prescription — something not required under its current temporary guidance. And then it proposes revised guidance for health systems that actually removes altogether any requirement for hospital compounders to have a patient-specific prescription under certain circumstances — and those circumstances are fairly broad. This looks an awful lot like a double standard.”
In addition to the concerns Brunner enunciates, the hospital guidance creates a big loophole to get around commercially available/essentially a copy requirements. “FDA’s guidance is far more permissive than what HR 3662 would accomplish, and doesn’t have the same safety guardrails APC made sure are built built into HR 3662,” added Brunner.
HR 3662 would allow 503As to source shortage drugs to hospitals only when those drugs are on the shortage list and unavailable from manufacturers or 503Bs. The legislation would require a patient-specific prescription after the fact. It also would require adverse event reporting. None of those are required in FDA’s draft guidance for health systems.
Notable in FDA’s objections to HR 3662 are the agency’s assertions that 503Bs can fill the gap when manufactured drugs are in shortage. “If that’s the case,” said Brunner, “Why haven’t they been able to fill that gap during the pandemic? Why did FDA need to issue temporary guidance allowing 503As to source Covid drugs under tight guardrails? There is indeed a place and great need for 503Bs, but their number and nimbleness are not at all as FDA describes to Congress in its comments on HR 3662. It’s a mirage.”
APC will submit comments to FDA on the draft hospital guidance and will be working with members of Congress to assure that their understanding of HR 3662 is accurate.
A federal district court judge has issued a summary judgment in favor of a group of compounding pharmacies, ruling that FDA’s MOU on interstate shipments of compounded drugs violated the law, and the agency cannot enforce it. The MOU will be remanded back to FDA, and the agency must “either certify that it will not have a significant economic effect on small businesses or prepare a regulatory flexibility analysis.”
While obviously not the end of issue, the ruling will allow APC and its coalition partners more time to work with FDA and boards of pharmacy to hopefully craft an MOU that’s less onerous for states to implement and which doesn’t expand FDA oversight beyond what the statute mandates.
The ruling was in response to a suit brought by a group of seven compounding pharmacies, led by Birmingham, Ala.-based Wellness Pharmacy, alleging several significant issues with the process FDA used to develop the MOU. It was a risky move for those pharmacies, but one that paid off.
The plaintiff pharmacies were Medquest Pharmacy, Wellness Pharmacy, Madame Rx, KEBD Enterprises, Hartley Medical Center Pharmacy, Womens International Pharmacy, and VLS Pharmacy. APC was party to an amicus brief filed on behalf of the plaintiffs.
The court found that, because FDA made arbitrary decisions that have “significant binding legal consequences for plaintiffs and pharmacies across the country, and […] signals a substantive change in the current legal regime governing interstate compounding,” the MOU becomes a legislative rule.
“As a result,” wrote United States District Judge Christopher Cooper, “FDA was required to comply with the Regulatory Flexibility Act before issuing it. It did not.”
“This was a great piece of news,” said APC Board Chair Shawn Hodges. “We were certain FDA overstepped its authority. And it was heartening to have Judge Cooper see the logic in our argument. I think it will help bring us to an MOU that’s fairer, and hopefully one APC can wholeheartedly endorse.”
Because it was released just this afternoon, we haven’t had time to study the 38-page ruling in depth. We’ll have a more detailed analysis in this week’s Compounding Connections newsletter, and we’ll certainly keep members informed of what happens next.
It won’t be long: “The Court,” Cooper wrote, “will request a progress report from the agency within sixty days.”
Here we are, six weeks out from APC’s congressional fly-in, Compounders on Capitol Hill. The exhibits are sold out. The hotel room block is filling up fast. (By the way, the preferred rate is only good through October 12.)
But our registration count right now is, well, meh. Not awful, but not so good either.
And, yeah, that’s making me sweat.
We need you to join us in Washington, DC, November 2-3 for visits with members of Congress. We’ve made it easy: In by noon on Tuesday and done by late afternoon Wednesday. For many of you, that will be only one night away from home. And the good you’ll do for your business will be worth far more than the cost of that hotel room ($215 a night, if you’re asking).
At our virtual town hall Wednesday, APC released the results of the first-ever “Snapshot of Pharmacy Compounding in America 2021,” along with a detailed report, the “2021 National Pharmacy Compounding Demographics Study.”
The study was commissioned by APC and conducted by the Center for Business Research at the University of Mary Washington — the results are based on data compiled from more than 725 pharmacy compounding professionals across the country.
“Details about the wide use of pharmacy compounding have been hard to come by in recent years,” said APC Chief Executive Officer Scott Brunner, CAE. “This Snapshot provides some definition for the profession here and now — how it’s structured, what compounders are doing in their businesses, and yes, what are the challenges they’re facing. It’s a level of helpful detail that we’ve not had in several years.”
Some key statistics:
During the pandemic, 67 percent of compounding pharmacies have prepared hand sanitizer for consumer use.
35 percent of compounding pharmacies are administering Covid-19vaccines.
43 percent are licensed in — and ship medications to — more than one state.
Almost 40 percent employ more than a dozen people.
77% of owners say compounded hormones are the most common type of compounded preparation they dispense, followed by dermatology preparations and animal medication.
87 percent of compounding pharmacies also do traditional, retail dispensing.
CBR’s Dr. Lance Gentry, PhD, said that “the data paints an inspiring story of American entrepreneurship overcoming obstacles. This study discovered how small entrepreneurs across America helped address the Covid-19 pandemic.”
APC leaders say they plan to share the report and Snapshot with state and federal regulators and lawmakers.
“Pharmacy compounding serves millions of patients in this country every day,” said APC President Michael Blaire of Scottsdale, Ariz. “It’s important that our elected officials and regulators understand the impact of pharmacy compounding in the American healthcare economy.”
You can download the full report, “2021 National Pharmacy Compounding Demographics Study” as well as the infographic, “Snapshot of Pharmacy Compounding in America 2021” and a video of the town hall meeting at A4PC.org/profile.
The Center for Business Research at the University of Mary Washington conducted the survey with assistance from APC supporters Letco, Medisca and PCCA.
APC applauds the heroic efforts of pharmacy compounders who continue to provide patients with access to vaccines and a wide variety of treatment options during the ongoing Covid-19 pandemic.
APC does not endorse any particular prescribed drugs or treatment for Covid-19 that meet the standard of care and satisfy all applicable federal and state statutes and rules. As set forth in APC’s Pharmacy Compounding Professional’s Code of Ethics, we continue to encourage compounders to uphold the triad relationship among patients, prescribers, and pharmacists and to work collaboratively in determining the course of treatment that is in the patient’s best interest. In making such decisions, pharmacists should exercise their professional judgment and remember that patient safety is always of paramount importance.
APC strongly cautions compounders against making claims of efficacy with respect to any drug that has not undergone the FDA’s premarket approval process or that is being prescribed for an off-label use.
The Nevada Board of Pharmacy has asked the state’s attorney general’s office whether state law requires that all out-of-state pharmacists who compound for patients in the state hold a Nevada pharmacist’s license. That’s pharmacists not pharmacies.
The law in question “requires any pharmacist compounding or dispensing any prescription for a controlled substance or dangerous drug for a patient located in Nevada to be registered with the board.”
For decades, the state has interpreted that to mean — as it does in most other states — that the out-of-state facility and (in some states) the pharmacist-in-charge must be licensed in Nevada. Now it seems to be considering the possibility that any individual pharmacist compounders who touches a compounded prescription to be shipped to Nevada must hold Nevada licenses.
Such a novel requirement would be onerous for pharmacies, clearly. But more importantly, it would cause untold disruption for patients’ medication access. Out-of-state compounding pharmacies — especially larger, national companies — would need to consider whether the burden of licensing every pharmacist in Nevada is worth the benefits of shipping to the state at all. And because the rule is not only related to compounded preparations, so would any entity — like, say, ExpressScripts, which employs hundreds of pharmacists — that ships medications into Nevada.
While it waits for the AG’s opinion, the BoP there is requiring all out-of-state pharmacist compounders to obtain a temporary license.
We’ve only had a short time to review them, but we’ve found several notable changes. The Compounding Expert Committee:
…expanded its guidance for assigning BUDs for compounded nonsterile preparations (CNSPs) in the absence of stability information.
…elaborated on the role of water activity in determining BUD limits for preparations.
…added a table of commonly compounded dosage forms and their respective aw values to aid compounders in determining BUD limits for CNSPs.
…clarified the requirements for identifying the need for a recall and related procedures.
…created of a Category 3 for CSPs that allows for “extended” BUDs with requirements above and beyond what is required for Categories 1 and 2
“Earlier this year, APC made recommendations to USP’s <795> and <797> CEC subcommittees, and we’re glad to see that some of our recommendations have been incorporated in these new proposals,” said APC President Michael Blaire. “Still, we’re concerned that the proposed revised chapters continue to place unnecessary limits on BUDs, even when sterility testing, increased environmental monitoring, increased personnel qualification, and stability studies are conducted.”
USP has also announced several open forums at which it will receive feedback on the proposed revisions. APC is reviewing the proposed revisions, and we will be participating in USP’s stakeholder process. We’ll have more details to share soon.
Phone: (281) 933-8400
Mailing: Alliance for Pharmacy Compounding
100 Daingerfield Road, Suite 401
Alexandria, VA 22314
APC is committed to addressing any concerns or complaints within one business day. Please send them — and, of course, any compliments — to firstname.lastname@example.org.