Specialty Practice: Compounding, Institutional Pharmacy, and Drug Distribution
Compounding
Know the federal framework (FDCA section 503A for patient-specific compounding and 503B for outsourcing facilities) and Alaska's compounding rules. Sterile compounding requires appropriate facilities, equipment, and personnel training; non-sterile compounding has its own standards. The trap: assuming a pharmacy may compound in bulk without meeting the outsourcing or patient-specific requirements, or that a sterile compound may be prepared without validated processes.
Institutional pharmacy
Hospitals and long-term care facilities have distinct rules: unit-dose distribution, floor stock controls, and the role of the pharmacist in the P&T process. The trap: assuming community pharmacy rules apply unchanged in institutions.
Drug distribution
Know the requirements for drug distribution systems, including returns, recalls, and the handling of investigational drugs. The trap: missing the documentation required for distribution records.
Traps
(1) Confusing 503A and 503B. (2) Sterile compounding without proper validation. (3) Applying retail rules to institutional settings. (4) Incomplete distribution records.
Rule of thumb
Match the setting to the rule set: retail, sterile compounding, or institutional-each has distinct requirements.
Worked example
A pharmacy wants to compound a sterile product for a hospital without a cleanroom. Not permitted; sterile compounding requires validated facilities and processes.