Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; Revision of Certain Labeling Controls; Partial Extension of Compliance Date

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 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 April 28, 1995 (60 FR 20897),

FDA partially extended the compliance date to August 2, 1996, for that

part of the final rule pertaining to items of cut labeling other than

immediate container labels. This document extends the compliance date

to August 1, 1997. FDA is taking this action to afford the industry

sufficient time to purchase necessary equipment or to take other steps

necessary to comply with certain provisions of the final rule, and to

provide additional time for the agency to consider any revisions to the

final rule.

DATES: Efffective July 19, 1996, the date for compliance with

Sec. 211.122(g) (21 CFR 211.122(g)) for items of labeling (other than

immediate container labels) is now extended to August 1, 1997. The date

of compliance for all other provisions of the final rule published

August 3, 1993 (58 FR 41348) remains August 3, 1994.

FOR FURTHER INFORMATION CONTACT:

Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-

7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD

20855, 301-594-1046, or

Paul J. Motise, Center for Drug Evaluation and Research (HFD-325),

Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855,

301-594-0098.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 1993

(58

[[Page 37680]]

FR 41348), FDA published a final rule that amended the labeling control

provisions in the CGMP regulations. The final rule defined the term

``gang-printed labeling,'' specified conditions for the use of gang-

printed or cut labeling, exempted manufacturers that employ certain

automated inspection systems from labeling reconciliation requirements,

and made other revisions intended to reduce the frequency of drug

product mislabeling and associated drug product recalls. One of the

three special control options for cut labeling is 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)).

In response to two citizen petitions requesting certain amendments

to Sec. 211.122(g) as it applies to cut labeling, a stay of the

effective date, and reopening of the administrative record, FDA, in the

Federal Register of August 2, 1994 (59 FR 39255), granted a partial

extension of the compliance date for certain provisions of

Sec. 211.122(g) to August 3, 1995, and a limited reopening of the

administrative record. In the Federal Register of April 28, 1995 (60 FR

20897), FDA granted a further partial extension of the compliance date

to August 2, 1996.

FDA extended the compliance date to provide industry with

additional time to comply with certain provisions of the final rule.

FDA found that additional time was needed to locate, install, and

validate scanning equipment and other necessary equipment to orient

items properly for bar code scanning because there was a shortage of

contract engineering personnel employed by some drug manufacturers to

evaluate, select, purchase, install, qualify, and validate labeling

verification systems.

FDA reopened 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) as defined in section 201(m)

of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m)), and

whether Sec. 211.122(g) expanded the proposed scope of the provision

from immediate container labels to all drug product labeling.

FDA has held 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. To assess this

information adequately, provide industry with adequate time to comply

fully with a final regulation, and provide additional time for FDA to

consider any revisions to the final rule, the agency is extending to

August 1, 1997, the compliance date for Sec. 211.122(g) as it applies

to items of labeling other than the immediate container label.

FDA's determination as to whether Sec. 211.122(g) will be retained

as currently codified or whether it will be revised will be published

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

that, under 21 CFR 211.125, a waiver of labeling reconciliation is

conditioned on a 100-percent examination for correct labeling performed

in accordance with Sec. 211.122(g)(2).

Dated: July 11, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-18285 Filed 7-18-96; 8:45 am]

BILLING CODE 4160-01-F