Drug Distribution Channels, Compounding, and Institutional Practice
Distribution channels
Drugs move through licensed manufacturers, repackagers, wholesale distributors, and pharmacies. North Carolina requires wholesale distributor permits, and DSCSA imposes tracing, verification, and transaction documentation. A pharmacy that sells to other pharmacies may need a wholesale distributor permit; do not assume the pharmacy permit covers wholesale distribution. Returns and recalls must be handled with documentation and segregation.
Compounding and institutions
Compounding must follow USP standards: USP <795> for nonsterile, <797> for sterile, and <800> for hazardous drugs. Establish beyond-use dates from stability and risk level, not convenience. Institutional pharmacies need a Board permit and must control floor stock, unit-dose distribution, and automated dispensing cabinets. A closed system still requires policies, security, and pharmacist oversight.
Worked example
A hospital wants to place an automated dispensing cabinet on a nursing unit. The pharmacy must approve drug selection, limits, and access; assign unique user codes; maintain override and discrepancy reports; and review restocking and expiration. The cabinet is not a way to bypass the pharmacist’s oversight or the hospital’s permit.
Traps
Thinking a pharmacy permit authorizes wholesale distribution; ignoring USP <797> when making sterile products; using arbitrary beyond-use dates; and treating institutional floor stock as unregulated.