[Federal Register Volume 61, Number 140 (Friday, July 19, 1996)] [Rules and Regulations] [Pages 37679-37680] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-18285] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. 88N-0320] Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls; Partial Extension of Compliance Date AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; partial extension of compliance date. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing a continuation of the partial extension of the compliance date for a provision of the final rule published in the Federal Register of August 3, 1993 (58 FR 41348). The document revised the current good manufacturing practice (CGMP) regulations for certain labeling control provisions. In the Federal Register of April 28, 1995 (60 FR 20897), FDA partially extended the compliance date to August 2, 1996, for that part of the final rule pertaining to items of cut labeling other than immediate container labels. This document extends the compliance date to August 1, 1997. FDA is taking this action to afford the industry sufficient time to purchase necessary equipment or to take other steps necessary to comply with certain provisions of the final rule, and to provide additional time for the agency to consider any revisions to the final rule. DATES: Efffective July 19, 1996, the date for compliance with Sec. 211.122(g) (21 CFR 211.122(g)) for items of labeling (other than immediate container labels) is now extended to August 1, 1997. The date of compliance for all other provisions of the final rule published August 3, 1993 (58 FR 41348) remains August 3, 1994. FOR FURTHER INFORMATION CONTACT: Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD- 7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1046, or Paul J. Motise, Center for Drug Evaluation and Research (HFD-325), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0098. SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 1993 (58 [[Page 37680]] FR 41348), FDA published a final rule that amended the labeling control provisions in the CGMP regulations. The final rule defined the term ``gang-printed labeling,'' specified conditions for the use of gang- printed or cut labeling, exempted manufacturers that employ certain automated inspection systems from labeling reconciliation requirements, and made other revisions intended to reduce the frequency of drug product mislabeling and associated drug product recalls. One of the three special control options for cut labeling is the use of ``appropriate electronic or electromechanical equipment to conduct a 100-percent examination for correct labeling during or after completion of finishing operations'' (Sec. 211.122(g)(2)). In response to two citizen petitions requesting certain amendments to Sec. 211.122(g) as it applies to cut labeling, a stay of the effective date, and reopening of the administrative record, FDA, in the Federal Register of August 2, 1994 (59 FR 39255), granted a partial extension of the compliance date for certain provisions of Sec. 211.122(g) to August 3, 1995, and a limited reopening of the administrative record. In the Federal Register of April 28, 1995 (60 FR 20897), FDA granted a further partial extension of the compliance date to August 2, 1996. FDA extended the compliance date to provide industry with additional time to comply with certain provisions of the final rule. FDA found that additional time was needed to locate, install, and validate scanning equipment and other necessary equipment to orient items properly for bar code scanning because there was a shortage of contract engineering personnel employed by some drug manufacturers to evaluate, select, purchase, install, qualify, and validate labeling verification systems. FDA reopened the administrative record to receive additional comments on the application of Sec. 211.122(g) to items of labeling (other than the immediate container label) as defined in section 201(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m)), and whether Sec. 211.122(g) expanded the proposed scope of the provision from immediate container labels to all drug product labeling. FDA has held a number of meetings with representatives of the labeling industry and others to determine control options available through current technology and to evaluate this information in light of comments received during the extended comment period. To assess this information adequately, provide industry with adequate time to comply fully with a final regulation, and provide additional time for FDA to consider any revisions to the final rule, the agency is extending to August 1, 1997, the compliance date for Sec. 211.122(g) as it applies to items of labeling other than the immediate container label. FDA's determination as to whether Sec. 211.122(g) will be retained as currently codified or whether it will be revised will be published in a future issue of the Federal Register. The compliance date for the remainder of Sec. 211.122, including Sec. 211.122(g) as it applies to immediate container labels, was August 3, 1994. The agency emphasizes that, under 21 CFR 211.125, a waiver of labeling reconciliation is conditioned on a 100-percent examination for correct labeling performed in accordance with Sec. 211.122(g)(2). Dated: July 11, 1996. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 96-18285 Filed 7-18-96; 8:45 am] BILLING CODE 4160-01-F