Documentation Requirements for Drug Transactions
- Every purchase transaction involving drugs and medicines must be properly documented with a sales invoice.
- The sales invoice must include critical details such as the lot or batch number from the manufacturer’s stock.
Consequences of Procuring from Unauthorized Sources
- Stocks obtained from illegitimate or unauthorized sources are considered violative and not approved by the Food and Drug Administration (FDA).
- Such stocks are subject to immediate seizure or confiscation as prescribed by LOI No. 1223 dated April 12, 1982.
Enforcement and Penalties
- The FDA is empowered to undertake further administrative and legal actions against violations.
- Possible actions include the prosecution of the owner, pharmacist, and other parties involved.
- The closure of the drug establishment may also be enforced as a penalty.
Authority and Implementation
- The directive is issued to ensure strict compliance by all concerned parties in the drug retail sector.
- Issued initially in 1983 and reissued in 1991 to reaffirm the commitment to drug safety and regulatory compliance under FDA supervision.