Regulatory Compliance and Documentation
Regulatory Compliance and Documentation
Compliance is layered: the FDA (approval, labeling, recalls, DSCSA), the DEA (controlled substances), state boards of pharmacy (licensure, facility standards), and standards bodies such as USP (<795>, <797>, <800>) plus accreditors like the Joint Commission, ACHC, or URAC.
Know the retention rules. Prescription and controlled-substance records are kept at least 2 years (many states require longer); DSCSA transaction records are kept 6 years; DEA Form 222/CSOS records, biennial inventories, and power-of-attorney documentation follow DEA rules. Temperature, cleaning, training, and competency logs are kept per facility policy. DEA registration renews every 3 years.
Know the forms cold: 222/CSOS = ordering Schedule II; 41 = destruction; 106 = theft or significant loss, reported in writing to the DEA field office within one business day of discovery. Document returns, recalls, and shortage-driven substitutions as well.
Worked example: a pharmacist finds 30 tablets of oxycodone missing during a count. That is a significant loss - complete DEA Form 106 and notify the field office within one business day, notify the state board if required, and run a root-cause review with corrective action.
Traps: swapping Forms 41 and 106; discarding records after 2 years when DSCSA requires 6; assuming an erroneous or altered paper 222 can be corrected - a defective form is void and a new one must be obtained.