6.2 Recordkeeping, Storage & Handling

Recordkeeping, Storage & Handling

Once drugs are acquired, the pharmacy must store them correctly, keep usable prescription records, and secure controlled substances. The PA MPJE tests the USP storage temperature definitions, the 2-year retention minimum, the rules for moving records off-site, and the federal security standards for Schedule II drugs.

Prescription Files Under §27.18(b)

49 Pa. Code §27.18(b) requires a pharmacy to maintain a prescription file for every prescription compounded or dispensed. Each file entry must show the patient name and address, prescriber name and address or other identifier, date of issue (required for controlled substances and PRN refills), drug name and quantity, directions, cautions communicated by auxiliary labels, date compounded and dispensed, and the name or initials of the dispensing pharmacist. Refill records must show refill date, dispensing pharmacist's initials, and quantity dispensed.

Retention minimum is 2 years from the date of the most recent filling (§27.14 mirrors this for original prescriptions). Controlled-substance records follow the federal 2-year minimum in 21 CFR 1304.04. After 2 years, a pharmacy may transfer records to an off-site storage location, but only after notifying the PA State Board of Pharmacy in writing; off-site storage must still permit retrieval within 72 hours of a Board request. Records transferred to microfilm or electronic image must preserve the audit trail.

Storage Temperature Requirements

Pennsylvania adopts the USP General Chapter <659> storage definitions. Pharmacists must store each drug according to its label. The most common exam-relevant temperatures:

Storage areas must be monitored with a calibrated thermometer, and the daily minimum and maximum temperatures logged. A refrigerator used for vaccines must be dedicated pharmacy storage — no food or beverages — and must have a continuous data logger or min/max thermometer. Excursions outside the labeled range must be documented and the manufacturer contacted for stability guidance before dispensing.

Controlled-Substance Storage (21 CFR 1301.72–1301.76)

Federal security rules apply to all registered pharmacies handling controlled substances:

• 1301.72 — Storage must be in a securely locked, substantially constructed cabinet, safe, or vault. Schedule II drugs require the highest security: a vault or DEA-approved safe, anchored, with combination or electronic access limited to authorized personnel.
• 1301.73 — Access is limited to persons duly authorized by the registrant; the PIC controls the authorization list.
• 1301.74 — The dispensing area must be alarmed or observed by personnel at all times the pharmacy is open.
• 1301.75 — A registrant must report theft or significant loss promptly (DEA Form 106).
• 1301.76 — Inspection by DEA is permitted at any reasonable time; PA Board inspectors have similar access.

PA does not add a separate state security cabinet requirement, but Board inspectors look for a secured, access-controlled area and a written access policy. The PIC is responsible for ensuring the combination is changed when authorized personnel leave.

Record Formats and Audit

PA pharmacies may keep records in paper, electronic, or a hybrid. An electronic system must:

1. Produce a printed, sortable audit trail on Board request.
2. Capture every dispensing event with date, drug, quantity, patient, prescriber, and dispensing pharmacist.
3. Not permit alteration without an audit-flagged entry;
4. Back up daily, with off-site or cloud backups;
5. Permit retrieval of any single record within 72 hours of a Board or DEA request.

A common Board inspection finding is a record that exists but cannot be located within a reasonable time — the inspector treats that as a missing record. The PIC should run quarterly self-audits: pull 10 random prescriptions, verify all §27.18(b) elements are present, and verify temperature logs are signed.

Temperature & Retention Quick Table

Exam Traps

• “May a pharmacy move 3-year-old prescription files to a warehouse?” — Yes, but only after notifying the PA Board in writing and ensuring 72-hour retrieval.
• “What temperature is refrigerated?” — 2–8°C, not 'under 8°C'; the lower bound matters.
• “Who controls the CII safe combination?” — The PIC, and the combination must be changed when an authorized employee departs.
• “Does PA require a perpetual inventory for non-CS?” — No; PA requires accurate records, but perpetual inventory is best practice, not a hard rule.