FDA 483 Observations in 503B Outsourcing Facilities

In this issue, we will continue our review of FDA 483 observations in 503B facilities, specifically looking at the "Facility."

FACILITY, Part 1

• Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are easily cleanable.
• Rust was observed on the base of several chairs being used inside of an ISO-7 room as well as rust on the bolts in the area below an ISO-5 BSC.
• Your firm did not document pressure differential readings between the ISO 8 Anteroom where gowning occurs and the ISO-7 room.
• Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions; specifically, your firm did not document the temperature in the incubators where the environmental and personnel monitoring samples are incubated.
• Aseptic process areas are deficient in that floors and walls are not smooth and/or hard surfaces that are easily cleanable.
• Your firm's floor drains appear un-clean and stained.
• Blue painter's tape was observed affixed to the corner of your cleanroom wall and glass frame covering the gap between areas.
• It was observed during production that with Compounding Suite ISO-7, the base of the loading ramp leading onto the floor production scale contains a black-colored substance and is stained.
• Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
• The design of the facility and operations in the main cleanroom result in a cluttered ISO-7 room in which personnel must turn sideways and hold up their arms to pass each other and which requires aseptic operators to routinely handle paper within the ISO-5 space.
• Printers are located directly beneath the workbenches which require the operator to print and handle the paper batch record for each IV unit produced.
• APIs were observed in an area of your warehouse where there is no temperature monitoring performed.

More next week.

FROM THE ALLIANCE FOR PHARMACY COMPOUNDING [APC]

Judge rules in favor of compounders, against FDA in lawsuit over MOU

A federal district court judge has issued a summary judgment in favor of a group of compounding pharmacies, ruling that the 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 the 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 the 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, Alabama-based Wellness Pharmacy, alleging several significant issues with the process the 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, Women's International Pharmacy, and VLS Pharmacy. APC was party to an amicus brief filed on behalf of the plaintiffs.

The court found that, because the 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."