AF 9-561 FILE NADA 55-056 John C. Stoner, D.V.!. Director, Veterinary Professional & Regulatory Affairs E.R. Squibb & Sons, Inc. P.0. LOX 4090 Princeton, NJ 00540 Dear Dr. Stoner: SEP 8 1975 We refer to your letter dated July 29, 1975, in which you submitted a supplemental now animal drug application for your product Princillin (sterile ampicillin suspension) Injection for use in dogs and cats. The application provides for the addition of the John D. Copanos, Inc., baltimore, (0, as an alternate manufacturer of the subject product. The labeling provided is identical to that previously approved, except that the qualifier "distributed by" is added and an additional change is the use of a 10 vial carton instead of the single vial carton. We wish to remind you that a Form 4 exemption for the bulk antibiotic will be needed to permit shipment from Squibb to Copanos unless other appropriate arrangement have been made. This supplemental new animal drug application is approved. This is in further rescease to your August 27 letter on behalf In order to be as useful as possible with respect to the records The Federal Food, Brug, and Cosmetic Act specifies that a drug shall In the case of frday Laboratories a larue orodure of fatravenous FILE hes Fromm 1/5/20 DATE In view of the potential hazard to health presented by distribution and use of these products. FDA requested the firm to voluntarily cease operations until its manufacturing systems could be qualified and to recall these products produced with a lack of assurance that they were safe (sterile). The firm complied with this request. McGaw, acting on the problems identified by FDA, accomplished the necessary corrections to achieve compliance with GMP Regulations during the six-month shut-dom period. The plant resumed operations on July 21, 1975, with the concurrence of FDA. Similar findings questioning product sterility were found during an Inspection of Travenol's Hays facility, a producer of small volume Injectables. The FDA proposed to enjoin Travenol through the Federal District Court in Wichita, Kansas. This Agency and Travenol worked out an agreement whereby the Hays facility was shut down and all products were recalled. We do not know what the firm's intentions are with regard to this plant. Both firms have facilities in other locations. Current GMP Regulations do not require that penicillin manufacturing facilities ba completely separate from facilities for nonpenicillin products. Based on the experience of FDA, however, there is a potential for hazardous contamination of nonpenicillin drugs with penicillin wherever common equipment or facilities are used for drug production. While the current GMP Regulations have an allowable tolerance for penicillin contamination in nonpenicillin products, the revision of the regulations (Federal Register proposal currently being developed) will delete the allowable tolerance for penicillin contamination of nonpenicillin drugs. The FDA finds that current good manufacturing practice in the industry has, to a large extent, eliminated penicillin cross-contamination by producing penicillin products in a separate building, or a separate area that has an air-handling system independent of other production areas, and is effectively sealed off from other parts of the building to prevent contamination of areas handling nonpenicillin products. The revision of GMP Regulations is expected to require that penicillin products be produced in a separate sealed-off area with a separate air-handling system. This will not necessarily require a separate building. We do not have a file which reflects the names of firms who propose to build a separate plant for penicillin production. We are aware that some firms have created a separate area within an existing building for the production of penicillin products, while others have constructed a separate plant for the production of penicillin products. In either case, exercising appropriate precautions, compliance with the expected revised regulations can be achieved. As indicated above, the current GMP Regulations refer to penicillin contamination under Title 21 Code of Federal Regulations, Section 211.58 (1) (copy enclosed). The revision of the CHP Regulations, when proposed in the Federal Register, will provide new conditions for penicillin production and will eliminate the current tolerance for penicillin contamination in nonpenicillin products. The Federal Register proposal, expected soon, will provide a time period and procedure for commenting. With respect to the request for the names of five former FDA employees now consulting for Squibb, we do not have records containing such Information. There is no requirement that a former employee keep us informed as to his occupational activities, nor do we have authority to engage in any surveillance. Of course, former FDA employees are personally responsible for observing the restrictions contained in the Federal Post-Employment statute (18 U.S.C. 207). This statute provides two restrictions on the activities of formar employees. The first precludes any former employee for a period of one year after separation from FDA, from acting as an agent before FDA on any particular matter which was under the employee's official responsibility while in FDA. The second restriction prohibits any former FDA employee from ever acting as an agent before FDA on a particular matter in which the employce participated personally and substantially while employed by this Agency. Although we have no specific file of former FDA employees consulting for Squibb, through conversation with staff personnel in the Bureau of Drugs, we did learn of one former FDA employee who has contacted FDA with regard to a consulting contract he has with Squibb. The name of this former employce is Amiel Kirschbaum, who several years ago was the Director of the National Center for Antibiotic Analysis, a unit of the Bureau of Drugs. His contact with FDA did not involve the problem of penicillin cross-contamination. We hope this information is helpful to you and the 011, Chemical and Atomic Workers International Union. |