[Federal Register: July 29, 1997 (Volume 62, Number 145)]
[Rules and Regulations]
[Page 40447]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy97-4]
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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:
kuchenbergt@cder.fda.gov), 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: motise@cder.fda.gov).
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