The Compounded Cream and the Unapproved Drug
A Georgia pharmacy compounds a topical cream containing a bulk drug substance that is not the subject of an applicable USP/NF monograph and is not a component of an FDA-approved drug. The pharmacy has a section 503A exemption and compounds for individual patient prescriptions. A local dermatologist asks the pharmacy to make a 500-unit batch to keep on the shelf for walk-in patients, and to add a small amount of a substance that is on FDA's list of drugs withdrawn for safety reasons. The pharmacy's designated representative for its wholesale distributor permit is the same pharmacist. The pharmacy also wants to ship 50 units to a physician's office in a neighboring state.
1. Can the pharmacy make the 500-unit shelf batch and include the withdrawn substance? Analyze under section 503A and Georgia compounding rules.
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No on both counts.
Batch for walk-ins: Section 503A protects compounding pursuant to a patient-specific prescription (or a limited anticipatory basis under FDA guidance). A 500-unit batch held for unspecified walk-in patients is manufacturing, not compounding, and falls outside 503A. It would require FDA registration as a manufacturer and would violate Georgia Board rules on compounding.
Withdrawn substance: Section 503A expressly excludes bulk drug substances that are components of drugs withdrawn or removed from the market for safety reasons (21 U.S.C. § 353a(b)(1)(C); 21 CFR 216.24). Including it is prohibited regardless of prescription status.
Bulk substance not in a monograph and not in an approved drug: Under 503A, a bulk substance must comply with a USP/NF monograph, be a component of an FDA-approved drug, or appear on FDA's list of bulk substances that may be used in compounding. If it meets none of these, it cannot be used. The pharmacist must verify the substance's status before compounding.
Georgia: Board compounding rules require patient-specific prescriptions, appropriate equipment and records, and prohibit manufacturing-scale production under a pharmacy permit.
2. What are the implications of shipping 50 units to an out-of-state physician's office, given the pharmacy's wholesale distributor permit?
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Compounding vs. distribution: Shipping 50 units to a physician's office for that office to dispense is distribution, not dispensing pursuant to a patient prescription. Under 503A, a compounded drug may not be distributed to a physician's office for office dispensing in quantities exceeding the office's needs for patient-specific prescriptions, and the pharmacy cannot use its 503A status to act as a manufacturer/wholesaler of compounded drugs.
Wholesale distributor permit: Holding a Georgia wholesale distributor permit does not authorize distributing unapproved compounded drugs in interstate commerce. The pharmacy must comply with the destination state's licensure requirements (nonresident pharmacy/wholesale license) and federal FDCA rules. If the product is an unapproved new drug, interstate shipment can trigger FDCA violations.
Designated representative: The pharmacist as designated representative is personally responsible for wholesale distribution records, licensure, and compliance. Shipping compounded products under the wholesale permit without confirming the product's legal status and the destination state's requirements creates personal and entity exposure.
Correct course: Decline the batch and the interstate office shipment; compound only patient-specific prescriptions; verify bulk substance eligibility; and, if the pharmacy genuinely wants to distribute, obtain the correct FDA registration and state licenses and ensure the product is lawfully marketed.