Citing Unnecessary Risks, FDA Proposes New Restrictions on Certain ...
www.nelsonhardiman.com › Featured Articles › Healthcare Ventures
13 hours ago - U.S. Food and Drug Administration (FDA), pharmacy compounding is “a practice in which a licensed pharmacist
1 comment:
Almost twenty years ago, under the 1997 Food and Drug Administration Modernization Act (FDAMA), certain requirements were carved out of the Food Drug and Cosmetic Act for compounded medications made in pharmacies. Conditions were included--the compounding provisions of FDAMA struck a delicate balance that permitted pharmacies to advertise the professional service of compounding, while prohibiting the marketing of specific compounded products generally associated with a commercial enterprise. This rational public health policy helped to ensure patient access to providers of professional compounding services should their medical care require a special formulation not otherwise commercially available, while preventing a the growth and expansion of a largely unregulated drug industry. This was not desirable for some compounding pharmacies and the businesses supporting them. FDAMA was quickly upended, the advertising restrictions were removed and compounding pharmacies both large and small adopted commercial business models focused on promotion and sales.
This summary of FDA guidance is an important read. In order for the public to reduce unnecessary exposure to a compounded drug's potential risks, they need to know they are receiving one (they or their doctors may have been uninformed susceptibles to guerrilla marketing tactics), what the anticipated benefits and risks are, and whether or not a commercial alternative exists.
Post a Comment