Question & AnswerQ&A (BFAD MEMORANDUM CIRCULAR NO. 20 S. 1992)
The purpose of BFAD Memorandum Circular No. 20 s. 1992 is to authorize specific outlets to sell and dispense Nalbuphine Hydrochloride (Nubain Injection) 10 mg/mL, in addition to government hospitals, by amending the Certificate of Product Registration (CPR) to include these outlets.
The circular specifically addresses Nalbuphine Hydrochloride 10 mg/mL (Nubain Injection) manufactured by Boots Pharmaceuticals, Inc.
The CPR must indicate the names of the authorized outlets allowed to sell Nalbuphine Hydrochloride in addition to government hospitals.
No, only the outlets specifically listed in Annex 'A' of the memorandum are authorized to carry and dispense Nalbuphine Hydrochloride 10 mg/mL.
The authorized outlets cover Metro Manila, Luzon, Visayas, and Mindanao regions.
No, drugstores not listed in the authorized outlets are not permitted to sell or dispense the product, and doing so would be a violation of the memorandum and relevant laws.
The amendment legally restricts the sale of Nalbuphine Hydrochloride to only the listed outlets and government hospitals, making it a compliance requirement for the manufacturer and the sellers.
The authorized outlets include specific commercial drugstores and pharmacy chains listed in Annex 'A', such as Mercury Drug Chain and regional drugstores across different provinces.
Understanding this memorandum is important because it illustrates regulatory controls imposed by the Philippine government on the distribution of controlled substances, emphasizing the role of the BFAD and compliance with the law in pharmaceutical distribution.