South Carolina Board of Pharmacy's Position on Domperidone powder

Compounding – Carole Russell, R.Ph. The committee made a motion to ask the Board for approval of their proposed USP 797 revisions and comments to USP. A second to the motion is not required when coming from a committee. It passed unanimously.The committee made a motion to ask the Board to approve the following advice for the inspectors on how to handle Domperidone questions: 1. When a facility has a Domperidone powder that has a British Pharmacopeia Monograph that isn’t labeled for veterinary use only, remind the pharmacist that it may disqualify them from their 503A exempt status upon inspection by the FDA. 2. If a facility has this powder and it’s labeled for veterinary use only and it’s being used for human products, follow procedures for handling as a misbranded or adulterated product. 3. A facility may use “for veterinary use” powder to compound veterinary prescriptions. A second to the motion is not required when coming from a committee. It passed unanimously. The committee made a motion to approve the Non-Sterile Compounding List of Requirements for Non-Dispensing Permit. A second to the motion is not required when coming from a committee. It passed unanimously. The committee formed a sub-committee/working group to work on the sterile compounding inspection form and will present to the board after completion.

quoted from South Carolina Board of Pharmacy January 13, 2016 Minutes