[Federal Register Volume 62, Number 145 (Tuesday, July 29, 1997)]
[Rules and Regulations]
[Page 40447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19818]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 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.

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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), revising the packaging and labeling 
control provisions of the current good manufacturing practice (CGMP) 
regulations for the use of cut labeling. FDA is extending the date for 
compliance with a specific provision, as it applies to labeling other 
than immediate container labels, until the effective date of the 
regulation finalizing the proposed rule on this subject published 
elsewhere in this issue of the Federal Register.

DATES: The date for compliance with the cut labeling provision at 
Sec. 211.122(g) (21 CFR 211.122(g)), as it applies to labeling other 
than immediate container labels, is extended until the effective date 
of the regulation finalizing the proposed rule on this subject 
published elsewhere in this issue of the Federal Register. The date for 
compliance with all other provisions of the August 3, 1993, final rule 
remains August 3, 1994.

FOR FURTHER INFORMATION CONTACT:
    Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-
7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5621 (Internet electronic mail: 
[email protected]), or
    Paul J. Motise, Center for Drug Evaluation and Research (HFD-325), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
301-594-1089 (Internet electronic mail: [email protected]).

SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 1993 
(58 FR 41348), FDA published a final rule amending the current good 
manufacturing practice (CGMP) regulations to require that special 
control procedures be instituted if cut labeling is used in packaging 
and labeling operations. One of these procedures requires 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)). The rule applied to all 
types of labeling, including product inserts, multiunit containers 
packaged in individual containers, and shipping containers.
    In May 1994, FDA received two citizen petitions from several trade 
associations requesting that the agency extend the effective date of 
the rule and reopen 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. The petitions stated that 
additional time was needed to obtain, install, or validate equipment 
necessary to comply with the rule. The citizen petitions also asserted 
that the final rule inappropriately expanded the scope of 
Sec. 211.122(g) from immediate container labels to all drug product 
labeling.
    In the Federal Register of August 2, 1994 (59 FR 39255), FDA 
extended the compliance date for Sec. 211.122(g) as it applies to 
labeling other than immediate container labels, and opened the 
administrative record through October 4, 1994, for comments on the 
scope of Sec. 211.122(g). All other provisions of the final rule became 
effective on August 3, 1994. FDA further extended the compliance date 
to August 2, 1996, in the Federal Register of April 28, 1995 (60 FR 
20897), and to August 1, 1997, in the Federal Register of July 19, 1996 
(61 FR 37679).
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule that would limit the scope of Sec. 211.122(g) to 
immediate container labels, individual unit cartons, or multiunit 
cartons when immediate containers are not packaged in individual 
cartons. The proposed rule would also permit the use of any automated 
technique, including differentiation by labeling size and shape, that 
physically prevents incorrect labeling from being processed by labeling 
and packaging equipment.
    In this final rule, FDA is extending the date for compliance with 
Sec. 211.122(g), as it applies to labeling other than immediate 
container labels, until the effective date of the regulation finalizing 
the proposed rule on this subject published elsewhere in this issue of 
the Federal Register. The date for compliance with all other provisions 
of the August 3, 1993, final rule remains August 3, 1994.
    Dated: July 22, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-19818 Filed 7-28-97; 8:45 am]
BILLING CODE 4160-01-F