APhA comments on two FDA compounding draft guidances

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Association submits recommendations on insanitary conditions at compounding facilities and on compounded drug products that are essentially copies of a commercially available drug product

Compounding is an important part of pharmacy practice as it permits patients with unique medical needs to have access to vital medications.  APhA recently submitted comments to FDA on two draft guidance documents related to compounding.

On October 3, APhA submitted comments on FDA’s draft guidance on insanitary conditions at compounding facilities.

The Association highlighted concerns that certain provisions in the draft guidance seemed to go beyond congressional intent under section 503A of the Food, Drug, & Cosmetic Act by imposing higher standards on compounding pharmacists and pharmacies than required by the states.

APhA also recommended FDA modify certain provisions and language in this draft guidance to accommodate nuclear pharmacists and pharmacies working with radiopharmaceuticals.

On October 11, APhA submitted separate comments on FDA’s draft guidance on compounded drug products that are essentially copies of a commercially available drug product.

The Association recommended that FDA modify the draft guidance to allow for clinician judgement and expand the scenarios for the compounding of commercially available drugs to include when compounding is reasonable, appropriate, and critical to meeting the needs of patients.  

APhA also expressed concern that the draft guidance will restrict the ability to meet the individualized needs of patients in different scenarios, including when drugs are unavailable but not yet listed on FDA’s drug shortage list. 

Updated November 8, 2016

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