Definition of Antibiotic Drugs
- Under Section 22(a) of RA 3720 as amended, an antibiotic drug is defined as any drug intended for human use that contains any quantity of a chemical substance produced by microorganisms that can inhibit or destroy microorganisms in dilute solution.
- This definition includes chemically synthesized equivalents of such substances.
Exclusion of Quinolone Derivatives and Veterinary Antibiotic Products
- Quinolone derivatives such as ciprofloxacin, difloxacin, enoxacin, fleroxacin, nalidixic acid, norfloxacin, ofloxacin, perfloxacin, and sparfloxacin, as well as veterinary antibiotic products, are excluded from the scope of the antibiotic drug definition requiring batch certification.
- These products are not strictly covered by the definition provided in Section 22(a) and thus are exempt from BFAD batch certification.
Regulatory Change and Effectivity
- Effective September 15, 1996, the BFAD ceased issuing batch certifications for quinolone derivatives and veterinary antibiotic products.
- This regulatory adjustment allows these products to be released for sale or distribution without BFAD batch certification.
Administrative Reference
- The circular was formally adopted on October 1, 1996, under the authority of Director Quintin L. Kintanar, M.D., Ph.D., CESO I, of the BFAD.
- This issuance serves to inform and guide relevant parties regarding the batch certification requirements concerning specific antibiotic products.