Importation of Active Pharmaceutical Ingredients (APIs) Requirements CPG 460.200 Pharmacy Compounding Compliance Policy Guides Manual (Tab M), in part provides:
Generally, FDA will continue to defer to state authorities regarding less significant violations of
the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases,
cooperative efforts between the states and the Agency will result in coordinated investigations,
referrals, and follow-up actions by the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of concerns
normally associated with a drug manufacturer and result in significant violations of the new
drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should
seriously consider enforcement action. In determining whether to initiate such an action, the
Agency will consider whether the pharmacy engages in any of the following acts:
1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited
quantities in relation to the amounts of drugs compounded after receiving valid
prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for safety reasons.
Appendix A provides a list of such drugs that will be updated in the future, as appropriate.
3. Compounding finished drugs from bulk active ingredients that are not components of FDA
approved drugs without an FDA sanctioned investigational new drug application (IND) in
accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
4. Receiving, storing, or using drug substances without first obtaining written assurance from
the supplier that each lot of the drug substance has been made in an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise determined to
meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding drug product
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or commercial
entities for resale.
8. Compounding drug products that are commercially available in the marketplace or that are
essentially copies of commercially available FDA-approved drug products. In certain
circumstances, it may be appropriate for a pharmacist to compound a small quantity of a
drug that is only slightly different than an FDA-approved drug that is commercially
available. In these circumstances, FDA will consider whether there is documentation of the
medical need for the particular variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the practice of
pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate
for consideration in a particular case.
Generally, FDA will continue to defer to state authorities regarding less significant violations of
the Act related to pharmacy compounding of human drugs. FDA anticipates that, in such cases,
cooperative efforts between the states and the Agency will result in coordinated investigations,
referrals, and follow-up actions by the states.
However, when the scope and nature of a pharmacy's activities raise the kinds of concerns
normally associated with a drug manufacturer and result in significant violations of the new
drug, adulteration, or misbranding provisions of the Act, FDA has determined that it should
seriously consider enforcement action. In determining whether to initiate such an action, the
Agency will consider whether the pharmacy engages in any of the following acts:
1. Compounding of drugs in anticipation of receiving prescriptions, except in very limited
quantities in relation to the amounts of drugs compounded after receiving valid
prescriptions.
2. Compounding drugs that were withdrawn or removed from the market for safety reasons.
Appendix A provides a list of such drugs that will be updated in the future, as appropriate.
3. Compounding finished drugs from bulk active ingredients that are not components of FDA
approved drugs without an FDA sanctioned investigational new drug application (IND) in
accordance with 21 U.S.C. § 355(i) and 21 CFR 312.
4. Receiving, storing, or using drug substances without first obtaining written assurance from
the supplier that each lot of the drug substance has been made in an FDA-registered facility.
5. Receiving, storing, or using drug components not guaranteed or otherwise determined to
meet official compendia requirements.
6. Using commercial scale manufacturing or testing equipment for compounding drug product
7. Compounding drugs for third parties who resell to individual patients or offering
compounded drug products at wholesale to other state licensed persons or commercial
entities for resale.
8. Compounding drug products that are commercially available in the marketplace or that are
essentially copies of commercially available FDA-approved drug products. In certain
circumstances, it may be appropriate for a pharmacist to compound a small quantity of a
drug that is only slightly different than an FDA-approved drug that is commercially
available. In these circumstances, FDA will consider whether there is documentation of the
medical need for the particular variation of the compound for the particular patient.
9. Failing to operate in conformance with applicable state law regulating the practice of
pharmacy.
The foregoing list of factors is not intended to be exhaustive. Other factors may be appropriate
for consideration in a particular case.
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