[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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