Pharmacy Operations, Recordkeeping, Inspections, and Federal Compliance
Records and retention
Prescription records, DEA records, inventories, invoices, and compounding logs must be complete, retrievable, and kept for the required period - at minimum the two-year federal standard for controlled substance records, and longer where Board rule specifies. Records must be readily retrievable for inspection; 'somewhere in the basement' is a deficiency. Prescriptions for controlled substances are filed so they can be separated by schedule on request.
Inspections
Board inspectors and DEA investigators may examine the pharmacy, records, security, and equipment. Prepare through routine self-inspection: license postings, current credential verification for every employee, security and alarm checks, temperature monitoring, expired stock segregation, and a current policy manual. Document corrective actions with dates and responsible parties; a repeat deficiency suggests an inadequate quality system.
FDCA and DSCSA
Products must be lawfully marketed, not adulterated, misbranded, or counterfeit. The Drug Supply Chain Security Act requires transactions only with authorized trading partners, receipt and retention of transaction information, transaction history, and a transaction statement, verification of product identifiers for suspect or illegitimate product, quarantine and notification when suspect product is found, and handling of saleable returns. FDA has issued time-limited enforcement exemptions for parts of the enhanced system, so verify the current compliance date rather than memorizing one.
HIPAA
Use and disclose protected health information for treatment, payment, and operations under the minimum-necessary standard; obtain authorization for marketing and psychotherapy notes; have business associate agreements; and notify affected individuals of breaches without unreasonable delay and no later than 60 days after discovery.
Worked example
An unfamiliar wholesaler offers oxycodone at a steep discount. Before ordering, verify the wholesaler's state licensure and status as an authorized trading partner, confirm the transaction data and product identifiers, and refuse the order if anything cannot be verified.