Drug Distribution, Compounding, and Special Populations
Distribution and compounding questions test the supply chain, USP standards, and safeguards for special populations.
Distribution
- Wholesale distributors need licensure and must comply with DSCSA tracking and verification requirements.
- Pharmacies may return, transfer, or destroy drugs only under lawful procedures; controlled substances require DEA forms and witnesses where required.
- Recalls require prompt identification, quarantine, and patient notification when necessary.
Compounding
- Nonsterile compounding follows USP <795>; sterile follows <797>; hazardous follows <800>. Assign beyond-use dates from the applicable standard and label them.
- Compounding must be patient-specific or in anticipation of a prescription under applicable rules; do not mass-manufacture without the correct registration.
- Verify ingredients, potency, and compatibility; document the master formula and lot numbers.
Special populations
- Long-term care and hospice use unit-dose, emergency kits, and consultant pharmacist oversight.
- Pediatric dosing is weight-based; counsel caregivers on measurement devices.
- Older adults need review for polypharmacy and renal dosing.
Worked example
A pharmacy prepares a sterile compounded injection but stores it beyond the USP <797> beyond-use date because the patient will pick it up later. This is not acceptable. The beyond-use date is a safety limit, not a convenience date. Assign the correct date, label it, and do not dispense after expiry.
Traps
- Using a room-temperature beyond-use date for a refrigerated product.
- Compounding a copy of a commercially available product without legal basis.
- Failing to document ingredients and lot numbers.
- Treating hospice as exempt from controlled-substance records.