Alabama Pharmaceutical professionals voice concerns over new regulations affecting compounding pharmacies. (Photo by Joe Raedle/Getty Images)
Pharmaceutical professionals in Alabama voiced their concerns Monday over new workplace safety requirements for compounding pharmacies.
The regulation would affect compounding pharmacies and retail pharmacies that make these drugs, or “compound” them by combining, mixing, or altering ingredients to create the medication, according to the Food and Drug Administration (FDA).
The regulation establishes guidelines to limit contamination, and it would require the affected pharmacies to upgrade or build new facilities to ensure proper handling. Under the regulation, pharmacies must have a negative-pressure rooms to minimize risk of exposure when handling hazardous drugs, and separate rooms for receiving and unpacking drugs, for storage and for the actual compounding.
Rep. Philip Rigsby, R-Huntsville, a pharmacist by training and owner of Huntsville Compounding Pharmacy, told the Alabama Board of Pharmacy at a Monday meeting that the cost of becoming compliant needs to be considered. Because of supply chain issues, he said building a unit that is compliant with the new regulation could take as long as two years.
“I think we all can agree that safety of our employees and safety of compounding is of the utmost importance … But the cost impact of USP 800 is something that cannot be ignored,” Rigsby said.
Louise Jones, chief executive officer at the Alabama Pharmacy Association, asked the board to not enforce new standards from the U.S. Pharmacopeia Convention (USP), as well as remove current USP standards. She said compliance with the regulations should be voluntary, not mandatory.
USP establishes standards for agencies and manufacturers to ensure that medications are not only safe for the consumers, but also for healthcare professionals.
“We believe that the Board of Pharmacy is responsible for setting the standards in Alabama, not USP,” Jones said. “We believe that working with the profession, that Alabama can set its own standards and provide a level of safety for our employees.”
Compounded medications are needed when a commercially available drug doesn’t address the patient’s needs adequately, either because of a patient’s intolerance to existing medications; the unavailability of the exact preparation required, or the patient’s need for a drug currently facing shortages or discontinuation.
Jones said that many community and rural pharmacies would likely have to discontinue services due to the financial burden of compliance, such as costly upgrades.
This would ultimately affect the patient, she said, such as pregnant people who need timely hormonal therapy. These patients may not be able to wait for a mail-in order “due to a local Alabama pharmacy not being able to provide these services.”
Supporters said that while implementing the new USP regulations could impact small pharmacists and patients who rely on these drugs, guidelines are needed to keep Alabama patients and workers safe.
Rigsby said that the pharmacy board should consider the level of enforcement as they roll out the regulations, which he said could be unfair to some pharmacies.
“There is going to be a lag time for some,” he said. “There’s going to be a big lag time for many. As I said earlier, depending on supply chain issues, could be up to two years.”
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