Federal Register / Vol. 60, No. 82 / Friday, April 28, 1995 / Rules and Regulations 20897

Dated: April 21, 1995.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 95–10487 Filed 4–27–95; 8:45 am]

BILLING CODE 8010–01–P

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 § 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’’

(§ 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

§ 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 § 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 § 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

§ 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 § 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 § 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 § 211.122, including § 211.122(g) as it

applies to immediate container labels,

was August 3, 1994. The agency

emphasizes, however, that § 211.125

makes a waiver of labeling

reconciliation conditional on a 100-

percent examination for correct labeling

performed in accordance with

§ 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

21 CFR Part 310

[Docket No. 77N–334S]

RIN 0905–AA06

Topical Drug Products for Over-theCounter Human Use; Products for the

Prevention of Swimmer’s Ear and for

the Drying of Water-Clogged Ears;

Final Rule; Correction

AGENCY: Food and Drug Administration,

HHS.