The U.S. Food and Drug Administration (FDA) may take action against a compounding pharmacy if certain violations are noted.


Reasons for an FDA enforcement action:

(1) Compounding a drug before receiving a valid prescription (exception: very limited amount prepared).

(2) Compounding a drug using an ingredient that has been withdrawn/removed because of safety reasons.

(3) Compounding a prescription using active ingredients that are not FDA approved.

(4) Receiving, storing or using material without written documentation that it was made in an FDA-registered facility.

(5) Receiving, storing, or using material not guaranteed or not determined to meet official compendia requirements.

(6) Using commercial scale manufacturing or testing equipment for compounding the prescription.

(7) Compounding a prescription for wholesale or for a third party that will resell it.

(8) Compounding a prescription which is essentially a copy of a commercially available, FDA-approved drug (exception: There is documentation that a small quantity is prepared and that it shows a particular variation intended for a particular patient).

(9) Failing to conform with the state pharmacy laws for the state in which the compounding pharmacy is located.


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