[Federal Register Volume 59, Number 147 (Tuesday, August 2, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18784]
[[Page Unknown]]
[Federal Register: August 2, 1994]
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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; Reopening of Administrative
Record
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; partial extension of compliance date; reopening of
administrative record.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a partial
extension of the compliance date of and giving interested persons an
opportunity to comment on the scope of a provision of the final rule,
which published in the Federal Register of August 3, 1993 (58 FR
41348), that revised the current good manufacturing practice (CGMP)
regulations for certain labeling control provisions. The agency is
taking this action to assess further the availability of equipment
necessary for compliance with the regulation for items of labeling
(other than immediate container labels) and to address concerns about
the scope of a particular provision of that rule in partial response to
two citizen petitions that were submitted to FDA.
DATES: The final rule published at 58 FR 41348, August 3, 1993, is
effective August 3, 1994. The labeling provisions (other than for the
immediate container label) in Sec. 211.122(g) must be complied with on
August 3, 1995, unless modified as discussed in section II. below.
Submit written comments by October 4, 1994.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT:
Tom 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:
I. Partial Extension of The Compliance Date
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 the options available under 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***.'' (21 CFR 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 Federal Food, Drug,
and Cosmetic Act (the act) (21 U.S.C. 321 (m)). The petition states
that additional time is needed because of the unavailability of bar
code or machine readers as well as other equipment necessary to orient
the labeling codes properly, and the petition also requests that FDA
reopen its administrative record to reassess the scope of a certain
provision of the regulation, as discussed in section II. of 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 is
needed to locate, install, and validate scanning equipment and other
necessary equipment to orient items properly for bar code scanning.
Currently, 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 has contacted vendors of this
equipment and has not found a general shortage of system hardware. The
agency has determined, however, that there may be a shortage of
contract engineering firms that are employed by some drug manufacturers
to evaluate, select, purchase, install, qualify, and validate labeling
verification systems.
FDA believes that proper validation of electromechanical labeling
control systems is vital to the effective operation of such systems and
the prevention of potentially dangerous labeling mixups. The agency is,
therefore, as discussed in section II. of this document, extending to
August 3, 1995, the compliance date of Sec. 211.122(g) as it applies to
items of labeling other than the immediate container label in order to
assess further the availability of equipment necessary for compliance
with the final rule and to evaluate adequately other issues raised by
petitioners.
II. Reopening of The Administrative Record
The first petition also requests 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 contend that final Sec. 211.122(g) expanded the
proposed scope of the provision from immediate container labels to all
drug product labeling.
Although FDA disagrees with these assertions, it is willing to
receive comments on this issue and to evaluate those comments in light
of the existing language in Sec. 211.122(g). After assessing the
comments, FDA will provide notice in the Federal Register of the
agency's decision on whether or not to retain Sec. 211.122(g) in its
current state. If the agency decides to retain the current provision,
compliance will be required on August 3, 1995. FDA notes that the
proposed rule is replete with references to ``labeling;''
Sec. 211.122(g), in fact, expressly addresses ``packaging and labeling
operations.'' FDA notes that it expressly directed its proposal to
control a method of printing, gang printing, because the cut labeling
that necessarily results from such a method has been implicated in a
number of recalls. Moreover, in the proposed rule, FDA announced its
intent to ``revise certain labeling control provisions. The changes are
intended to reduce the frequency of drug product mislabeling.'' (54 FR
26394 (emphasis added)). Immediately following, in the summary of the
proposed rule, FDA focused on the practices targeted for control,
stating ``The proposal specifies conditions for the use of gang-printed
or cut labeling***.'' (54 FR 26394 (emphasis added)).
Furthermore, in the proposal, FDA described the control procedures
to be used by ``labeling and packaging'' lines and in proposed
Sec. 211.122(g)(1), referred to one of the special control features as
the ``Dedication of labeling and packaging lines to each different drug
product * * *.'' (54 FR 26394 at 26395 (emphasis added)). Likewise, FDA
referred to the second special control feature in proposed
Sec. 211.122(g)(2), which provides for the ``use of appropriate
electronic or electromechanical equipment to conduct a 100-percent
examination for correct labeling***'' (54 FR 26394 at 26395 (emphasis
added)). Despite such explanations in the proposal, FDA will,
nonetheless, accept and review comments addressing the scope of
Sec. 211.122(g) with respect to its application to labeling, as that
term is defined in section 201(m) of the act.
FDA also reiterates its explanation of the terms ``cut labels'' and
``cut labeling'' in the preamble to the final rule: ```Cut labels' and
`cut labeling' are items of labeling that have been detached from
printed stock material prior to being brought to a labeling line***''
(58 FR 41348 at 41350 (emphasis added)).
This partial extension of the compliance date and limited reopening
of the administrative record grant, in essence, the requests of the
citizen petitions to have additional time for compliance with one
aspect of the final rule, while reserving judgment on the underlying
issues pending FDA's receipt and review of any comments. Compliance
with the remainder of Sec. 211.122, including Sec. 211.122(g) as it
applies to labels as that term is defined in section 201 of the act, is
expected on August 3, 1994. It is important to note, 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).
Interested persons may on or before October 4, 1994, submit to the
Dockets Management Branch (address above) written comments on this
final rule. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments are to be identified with the
docket number found in brackets in the heading of this document.
Received comments may be seen in the office above between 9 a.m. and 4
p.m., Monday through Friday.
This document is issued under sections 201, 501, 502, 505, 506,
507, 512, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 351, 352, 355, 356, 357, 360b, 371, 374).
Dated: July 27, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-18784 Filed 8-1-94; 8:45 am]
BILLING CODE 4160-01-F