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.

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

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