[Federal Register Volume 60, Number 82 (Friday, April 28, 1995)]
[Rules and Regulations]
[Page 20897]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10461]



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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.

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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, which was 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 August 2, 1994 
(59 FR 39255), FDA partially extended the compliance date for a 
provision of the regulation to August 3, 1995, and requested comments 
on the scope of this provision. The agency is further extending the 
compliance date to August 2, 1996. FDA is taking this action in order 
to adequately assess comments received on the scope of a particular 
provision of that rule.

DATES: The final rule published at 58 FR 41348, August 3, 1993, is 
effective August 3, 1994. The date for compliance with Sec. 211.122(g) 
for items of labeling (other than immediate container labels) is 
extended to August 2, 1996. The date of compliance for all other 
provisions of the final rule remains August 3, 1994.

FOR FURTHER INFORMATION CONTACT:
    Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-
362), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1046, or
    Paul J. Motise, Center for Drug Evaluation and Research (HFD-323), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 
301-594-1089.

SUPPLEMENTARY INFORMATION:

    In the Federal Register of August 3, 1993 (58 FR 41348), FDA 
published a final rule that amended the CGMP regulations to require 
that certain special control procedures be instituted if cut labeling 
is used. 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)).

    On May 4, 1994, FDA received a citizen petition from five trade 
associations requesting that the agency take a number of actions 
including, but not limited to, extending the August 3, 1994, effective 
date of this rule as it applies to labeling (other than the immediate 
container labels) as defined in section 201(m) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 321(m)). The petition 
stated that additional time was needed because of the unavailability of 
bar code or machine readers as well as other equipment necessary to 
orient the labeling codes properly, and requested that FDA reopen its 
administrative record to reassess the scope of a certain provision of 
the regulation, as discussed below in this document.

     On May 6, 1994, the agency received an additional petition from a 
trade association that requested, among other things, a 1-year stay of 
the effective date; the petitioner stated that additional time was 
needed to locate, install, and validate scanning equipment and other 
necessary equipment to orient items properly for bar code scanning.

    Appropriate electronic or electromechanical equipment primarily 
consists of systems that scan identity codes printed on labeling. If an 
incorrect code is detected, the defective labeling is ejected from the 
labeling line. FDA contacted vendors of this equipment and determined 
that while there was not a general shortage of system hardware, there 
was a possible shortage of contract engineering firms employed by some 
drug manufacturers to evaluate, select, purchase, install, qualify, and 
validate labeling verification systems.

    In response to this situation, FDA extended the compliance date of 
Sec. 211.122(g) as it applied to items of labeling (other than the 
immediate container label) to assess further the availability of 
equipment necessary for compliance with the final rule and to evaluate 
adequately other issues raised by petitioners.

    The first petition also requested that the agency reopen the 
administrative record to receive additional comments on the application 
of Sec. 211.122(g) to items of labeling (other than that of the 
immediate container label) as defined in section 201(m) of the act. 
Both citizen petitions contended that Sec. 211.122(g) expanded the 
proposed scope of the provision from immediate container labels to all 
drug product labeling.
    In response to the issues raised, FDA agreed to receive comments on 
this issue and to evaluate those comments in light of the existing 
language of Sec. 211.122(g). The comment period ended on October 4, 
1994, and since that time FDA has had 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.
    In order to adequately assess this information, determine whether 
any possible revision of the regulation should result, and provide 
industry adequate time to fully comply with a final regulation, FDA is 
extending the compliance date of Sec. 211.122(g) as its applies to 
items of labeling other than the immediate container label to August 2, 
1996. Should FDA determine, after completing its assessment of the 
comments, that Sec. 211.122(g) should be retained in its current state 
or revised, FDA will provide notice of that decision 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, however, 
that Sec. 211.125 makes a waiver of labeling reconciliation conditional 
on a 100-percent examination for correct labeling performed in 
accordance with Sec. 211.122(g)(2).

    Dated: April 24, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-10461 Filed 4-27-95; 8:45 am]
BILLING CODE 4160-01-F