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April 28, 1975 i4 / (jt - HYLAND D IV ISIO N T R A V E N O L L A B O R A T O R IE S , INC. Post Office Box 2214 3300 Hyland Avenue Costa Mesa, California 92626 (714) 540-5000 Alexander M. Schmidt, M.D. Commissioner Food and Drug Administration 5600 Fishers Lane R o ck v ille , Maryland 20852 Dear Doctor Schmidt: On March 14, 1975, the Food and Drug Administration published certain revisions to 21CFR133 (40FR11865-11869). These revisions addressed them selves to the elim ination of fib er- releasin g f i l t e r s during product manufacture [21CFR133.8(j)] and to the requirement that containers for parenteral drugs, drug products or drug components be cleansed with water filte r e d through a non-fiber-releasing f i l t e r (21CFR133.9). The e ffe c tiv e date of the order is given as A pril 14, 1975. We note that 21CFR133.8(j)(3) provides a hopefully reasonable time period for manufacturers to achieve substitution for fiber-releasing f ilt e r s that may cu rre n tly be used during production. However, the revised 21CFR133.9 had an e ffe c tiv e date of A p ril 14, 1975, meaning that manufacturers had only 30 days (le ss the time i t takes for d e live ry of the Federal Reg ister) to in s t a ll a su itab le non-fiber-releasing f i l t e r into th e ir container wash water lin e s . This, in our opinion, is not a s u ffic ie n t time period and f a i l s to recognize the impact on manufacturers. I f manufacturers can be allowed 18 months to elim inate fib er- releasin g f i l ters from production, we cannot see the need fo r requiring in s ta lla tio n of a membrane-type f i l t e r in wash water lin e s w ithin 30 days. We question what hazard ex ists to warrant th is urgency. Alexander M. Schmidt, M.D. April 28, 1975 Page 2 We urgently request that you publish a notice in the Federal Register delay ing the e f f e c t iv it y of revised 21CFR133.9 u n til a t le a s t September 14, 1975 Michael B. R o d e ll, Ph.D. Director of Regulatory A ffairs and C lin ic a l Development cc: John Adams, Ph.D. PMA