Title
Procurement of drugs only from legitimate sources
Law
Bfad Fda Memorandum Circular 001 S. 1983
Decision Date
Mar 10, 1983
Retailers are mandated to source drugs exclusively from authorized distributors, with strict penalties for non-compliance, to combat the distribution of substandard medications.
A

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.

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