In the recent warning letter to compounding pharmacy, the FDA states:
During the FDA inspection, the investigator observed that your firm produces drug products with domperidone. Compounded drug products containing domperidone are not eligible for the exemptions under section 503A of the FDCA because domperidone is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and it does not appear on a list of bulk drug substances that may be used for compounding developed by the Secretary. Accordingly, the drug products that you compound using domperidone are not entitled to the exemptions in section 503A of the FDCA.
quoted from FDA Warning Letter Dated February 3, 2015 to Perry Drug Inc. Attorney's representing compounding pharmacies need to make sure their clients are aware of this warning letter and that the pharmacies they represent are in compliance with all federal and state laws and regulations.
See also
Domperidone is not currently a legally marketed human drug and it is not approved ...While there are currently no pharmacies that are authorized to compound
During the FDA inspection, the investigator observed that your firm produces drug products with domperidone. Compounded drug products containing domperidone are not eligible for the exemptions under section 503A of the FDCA because domperidone is not the subject of an applicable USP or NF monograph, is not a component of an FDA-approved human drug, and it does not appear on a list of bulk drug substances that may be used for compounding developed by the Secretary. Accordingly, the drug products that you compound using domperidone are not entitled to the exemptions in section 503A of the FDCA.
quoted from FDA Warning Letter Dated February 3, 2015 to Perry Drug Inc. Attorney's representing compounding pharmacies need to make sure their clients are aware of this warning letter and that the pharmacies they represent are in compliance with all federal and state laws and regulations.
See also
Domperidone – How to Obtain - Food and Drug Administration
www.fda.gov/Drugs/.../ucm368736.htm
Food and Drug Administration
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