§ 431.12 - Certification of antibiotic drugs after shipment in bulk containers.

(a) The Food and Drug Administration has received inquiries from certain interested manufacturers concerning their shipment of certified antibiotics, packaged in bulk containers, to hospitals and pharmacies for repacking or for use in the manufacture of another drug on the order or prescription of a physician. The regulations promulgated under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) do not prohibit the shipment of certified bulk containers of antibiotics to such persons. However, under the provisions of § 431.11(b)(2)(i), certification should be requested of each repacked batch and of each batch of another drug manufactured from such bulk drug, unless the repackaged drug or other drug has been made exempt from the certification requirements by regulation. The fact that the drug is to be repacked or manufactured on the order or prescription of a physician does not exempt it from the certification requirements of the act. Under the provisions of § 431.11(b)(2)(ii), it is only when the drug used to compound a prescription is in a container packaged for dispensing that certification of the drug so compounded is not required.

(b) In the light of these provisions, unless the manufacturer and shipper of bulk containers of antibiotics has, with the consignee, an effective permit issued under § 433.16 of this chapter, if the drug is to be repacked, or under § 433.13 of this chapter if it is to be used in the manufacture of another drug, the shipper has the responsibility of seeing that certification is requested of each repacked batch and of each batch of another drug manufactured from such drug.