AHA recommends FDA actions to ease regulation, improve device security

AHA News Now

AHA again urged the Food and Drug Administration today to allow health system pharmacies to distribute compounded products to other system facilities located more than one mile away. “The AHA is concerned that the one-mile radius limitation [included in draft guidance last year] is not workable for many... read more

Topic: Advocacy and Public Policy
Tags: Drug Compounding, Cybersecurity, regulation

FDA issues draft guidance on insanitary conditions for compounding facilities

AHA News Now

The Food and Drug Administration today issued draft guidance for pharmacies, physician offices and outsourcing facilities that compound or repackage drugs or mix, dilute or repackage biological products. The guidance provides examples of insanitary conditions under the Federal Food, Drug and Cosmetic Act,... read more

Topic: Advocacy and Public Policy
Tags: quality, patient safety, physicians, Drug Compounding, regulation

AHA recommends changes to FDA draft hospital and health system compounding guidance

AHA News Now

The AHA today urged the Food and Drug Administration to revise its draft compounding guidance to allow hospital and health system pharmacies to continue to distribute compounded drug products to other health care facilities in the same system. The AHA “strongly recommends that the FDA remove the arbitrary... read more

Topic: Advocacy and Public Policy
Tags: Drug Compounding, regulation

FDA issues draft guidance on hospital and health system compounding

AHA News Now

The Food and Drug Administration today issued draft guidance explaining how it intends to apply section 503A of the Federal Food, Drug and Cosmetic Act to drugs compounded in state-licensed hospital or health system pharmacies for use within the hospital or health system. Pharmacies located within a... read more

Topic: Advocacy and Public Policy
Tag: Drug Compounding

AHA urges FDA to clarify draft memorandum on compounded drugs

AHA News Now

The AHA today urged the Food and Drug Administration to clarify certain provisions in its draft memorandum of understanding with states for interstate distribution of compounded drugs, which pharmacies seeking exemption from certain FDA requirements must satisfy. Specifically, AHA urged the agency to... read more

Topic: Quality and Patient Safety
Tags: patient safety, Drug Compounding

Senators concerned about draft FDA guidance on repackaging biologics

AHA News Now

Leaders of the Senate Special Committee on Aging yesterday expressed concerns with the Food and Drug Administration’s draft guidance for compounding and repackaging biologics. “In particular, we are concerned that the beyond-use-dates proposed in the draft guidance would not allow doctors enough time to... read more

Topic: Advocacy and Public Policy
Tag: Drug Compounding

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