FDA seems to have a clear delineation about which pharmacies can and cannot compound for office use, but the issue appears much grayer in some states.

FDA interprets the Drug Quality and Security Act as permitting only registered outsourcers to compound without receiving an individual prescription, but that finding conflicts with some state laws that specifically allow traditional pharmacies to compound for office use.

It creates an unenviable dilemma for pharmacists: whether to follow FDA regulations or those of their state.

The International Academy of Compounding Pharmacists argues that FDA is not following the congressional intent of the Drug Quality and Security Act (DQSA), which was that office use regulation should be left to the states.

Academy executive VP and CEO David Miller said the group wants FDA and/or Congress to clarify the office use issue as well as write other necessary regulations so pharmacists can operate under DQSA.

“It is much more cloudy, muddy, messed up, uncertain, unclear, than we had, even from the compounding professionals’ standpoint, originally anticipated,” Miller said May 19 during a media briefing.

Guidance may be coming, but it is unclear how the agency would address the office use issue.

IACP is conducting its annual Compounders on Capitol Hill conference May 17-20. The academy invited a number of FDA officials to speak at the event, but was told they were not available.

Miller suggested the office use issue could end up in court.

“This will end up in court because there are big questions about some federal and states’ rights,” he said.

“There’s some big, big constitutional questions that are very similar in nature to the constitutional question that was associated with [compounding oversight] all the way back in the late 1990s.”

Among the prompts for DQSA, in addition to the deadly meningitis outbreak that was traced to drugs compounded at the New England Compounding Center, were court rulings that made FDA authority over compounding unclear Also see "FDA Wants Compounding Authority Clarified, Congress Not So Sure It’s Necessary" - Pink Sheet, 15 November, 2012..

DQSA passed in 2013 as an effort to make clear whether FDA or state boards of pharmacy were the primary overseer of compounding pharmacies. Sen. Lamar Alexander, R-Tenn., said he wanted to know who was on the flag pole Also see "Compounding The Problem: Congress, FDA Argue Over Regulatory Responsibility" - Pink Sheet, 19 November, 2012..

Traditional pharmacy regulation was left to states, but FDA was given the ability to oversee compounders that register as outsourcing facilities. While registration was voluntary, the agency said hospitals and providers should encourage compounders to become outsourcers ([A#14140110003]).

Outsourcers also are allowed to compound for office use. It was expected to be one of the reasons to submit to FDA oversight, which includes risk-based inspections, adverse event reporting and annual user fee payments ([A#14131118004]).

Funding Conditioned On Regs

As part of the conference IACP representatives will travel to Capitol Hill and push Congress to clarify the office use problem.

Miller said they also will ask appropriators to keep some of the money earmarked for inspections of traditional compounders on hold until FDA writes rules giving them clear direction.

Gary McCrory, owner of an El Paso, Texas pharmacy and IACP VP, said during the briefing that he would be in violation if FDA inspectors visited.

McCrory owns what he said is a traditional pharmacy practice that would be under state regulation, but also compounds medications for office use. Texas allows traditional pharmacies to engage in office-use compounding.

States also continue to work with FDA to make sure work is not duplicated and facility inspections are more frequent ([A#00140512011]).

FDA warning letters have cited compounders for producing drugs without individual prescriptions and may have implied that those pharmacies wishing to engage in office-use compounding should register with the agency ([A#14140128005]).

Other stakeholders have argued that compounders who produce office stock should be encouraged to register with the agency, especially if they are large operations, because of the risk if product contamination occurs ([A#00140210002]).

The issue also is important for drug manufacturers like Genentech Inc., which makes Lucentis (ranibizumab) for treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion and diabetic macular edema.

Pharmacists often compound the company’s Avastin (bevacizumab) for wet AMD in part because it is cheaper than Lucentis Also see "Ophthotech Underscores Limitations Of Anti-VEGFs in Wet AMD" - Pink Sheet, 8 March, 2014..

Which GMPs Do I Follow?

FDA has listed more than 40 registered outsourcing facilities on its website, but a number of others also may be waiting in the wings.

Miller said a number of pharmacists are thinking of becoming outsourcers, but since FDA has not issued outsourcer regulations, many are waiting.

“We do believe that there are other outsourcing facilities out there that will come into the marketplace … once the agency gives clearer direction as to what their expectations are,” he said.

FDA has stated that outsourcing facilities will have to follow some Good Manufacturing Practices, but has yet to formally issue them ([A#14130509006]).

FDA Power v. State Laws: Compounders Want Clarity On Office Use

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