Maintenance of Records in Drug Stores is a fundamental requirement for both retail and wholesale drug stores.
Proper record-keeping ensures traceability, accountability, and regulatory compliance.
Here's a breakdown of the common record-keeping requirements for both entities.
Retail Pharmacies
1) Prescription Records
Retention: Keep for 2-10 years in secure storage.
Details: Patient and prescriber info, medication details, dispensing date, pharmacist ID.
2) Controlled Substances
Inventory: Perpetual record of receipts and disbursements.
DEA Compliance: Use DEA Form 222 for Schedule II; report losses.
3) Patient Profiles
Records: Track medication history, allergies, adverse reactions.
Confidentiality: Follow HIPAA and secure against unauthorized access.
4) Financial Records
Sales: Document all sales, especially ID-required OTC.
Insurance: Record third-party transactions and claims.
Wholesale Drug Stores (Maintenance of Records in Drug Stores)
1) Inventory Records
Stock: Track receipts, storage, distribution with batch info.
Audits: Regular inventory reconciliation.
2) Transaction Records
Purchasing: Keep purchase orders, invoices, receipts.
Sales: Document sales details as per regulations.
3) Controlled Substances
Compliance: Maintain strict records; monitor unusual orders.
4) Quality Assurance
Product Checks: Record quality, temperature checks, recalls.
Compliance Docs: Keep licenses and inspection records.