[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
