Authorized Outlets and Geographic Coverage
- Only outlets officially listed are permitted to carry and dispense the product.
- Authorized outlets include a detailed list of drugstores across Metro Manila, Luzon, Visayas, and Mindanao.
- The list includes well-known pharmacy chains and independent drugstores in strategic locations.
Procedure for Dispensing
- Outlets must comply strictly with the listing to legally dispense Nalbuphine Hydrochloride.
- The amendment enforces accountability by Boots Pharmaceuticals, Inc. for supply control.
Regulatory Authority and Enforcement
- The directive is issued by the Director of the Bureau of Food and Drugs (BFAD), granting regulatory authority.
- BFAD will oversee and ensure compliance with the amended CPR conditions.
Legal and Public Health Implications
- Restricting sales to authorized outlets helps prevent misuse and illegal distribution of narcotic or psychotropic substances.
- Maintains public safety and ensures proper medical dispensing protocols are followed.
Penalties (Implied)
- Selling Nalbuphine outside the authorized outlets may result in legal consequences under existing pharmaceutical laws and BFAD regulations.
- Suspensions or revocation of CPR for non-compliant outlets or manufacturers may apply.