The Food and Drug Administration Friday issued final guidance clarifying that an organization may operate both a compounding pharmacy and outsourcing facility at the same address or general location if they are completely segregated by clearly identified boundaries, for example permanent physical barriers such as walls or doors that are locked. If the pharmacy is not completely segregated from the outsourcing facility, FDA would generally consider the pharmacy part of the outsourcing facility and subject to Section 503B of the Federal Food, Drug and Cosmetic Act and current good manufacturing practice, the agency said. Both compounders also should clearly label their drug products as compounded at a pharmacy or outpatient facility, FDA said. The Drug Quality and Security Act of 2013 created the outsourcing facility category.
AHA expresses support for the Maternal Health Accountability Act (S. 1112), as amended and passed by the Senate Health, Education, Labor and Pensions Committee…
This AHA Legislative Advisory offers a detailed summary of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for…
Northern Maine Medical Center – Fort Kent, Maine
AHA letter to the US Senate supporting Amendment #3787 to address ‘out-of-control cost’ of prescription drugs.
AHA comments on the Department of Health and Human Services’ Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
On June 6, President Trump signed into law the VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018, (S. 2372), known as…