[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