[Federal Register Volume 60, Number 77 (Friday, April 21, 1995)]
[Rules and Regulations]
[Pages 19846-19847]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-9951]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 206

[Docket Nos. 88P-0380 and 89P-0163]


Imprinting of Solid Oral Dosage Form Drug Products for Human Use; 
Clarification

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; clarification.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations requiring the imprinting of solid oral dosage form drug 
products for human use. This final rule clarifies FDA's intent 
regarding the effective date for drug products introduced or delivered 
for introduction into interstate commerce.

DATES: Effective September 13, 1995; written comments by July 20, 1995.

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: Deborah A. Wolf, Center for Drug 
Evaluation and Research (HFD-362), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1046.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 13, 1993 (58 FR 47948), FDA 
published a final rule requiring the imprinting of all solid oral 
dosage form drug products for human use. The regulation requires that 
all drugs covered by it bear an imprint that will permit the 
identification of the drug product, including its active ingredients 
and dosage strength, and its manufacturer or distributor. The 
regulation was based on a proposed rule that was published in the 
Federal Register of May 15, 1991 (56 FR 22370). The preamble to the 
proposed rule stated that, among other things, any final rule based on 
the proposal would become effective 1 year after its date of 
publication in the Federal Register. The preamble also stated that any 
drug product subject to the requirements of this rule that is 
``introduced or delivered for introduction into interstate 
commerce''after the effective date would be deemed to be adulterated, 
misbranded, or an unapproved new drug, unless it is imprinted in 
compliance with the regulation (see 56 FR 22370 at 22375 (emphasis 
added)). Under the proposed rule, FDA intended the rule to be effective 
for drug products entering interstate commerce at the manufacturing 
level 1 year after the date of publication of a final rule in the 
Federal Register.
    In response to the proposed rule, many drug companies commented 
that 1 year was insufficient time to comply with the requirements of 
the rule. Industry comments indicated that it would take longer than 1 
year for equipment retooling and product imprinting.
    In response to industry's concerns, FDA provided for an 
implementation period of 2 years. The agency intended to provide an 
effective date of September 13, 1995, which is 2 years after its date 
of publication in the Federal Register.
    However, in revising the final rule to provide for a 2-year 
implementation period, the agency inadvertently replaced the reference 
to drug products ``introduced or delivered for introduction into 
interstate commerce'' with a reference to drug products ``distributed 
in interstate commerce'' (see 58 FR 47948 at 47950) (emphasis added). 
This change created the misimpression that FDA intended the rule to 
apply to drug products distributed by manufacturers, repackers, and 
retail distributors, thereby increasing, rather than decreasing, the 
burden on the pharmaceutical industry. FDA has received inquires 
expressing concern that FDA intended to initiate recall actions at the 
retail level because ``distribution'' would include sale at that level.
    This final rule amends 21 CFR 206.10(a) by replacing the language 
``distributed in interstate commerce'' with ``introduced or delivered 
for introduction into interstate commerce.'' This will clarify the 
requirements of the rule as it pertains to products in interstate 
commerce.
    Because this amendment to the imprinting regulations makes only a 
change necessary to conform the rule to FDA's original intention as 
stated in the preamble to the proposed rule and to be consistent with 
the agency's intent to provide a 2-year implementation period as 
provided for in the final rule, notice and public procedure are 
unnecessary. FDA finds that there is good cause to dispense with notice 
of proposed rulemaking, pursuant to 5 U.S.C. 553(b)(3)(B). FDA is 
therefore publishing this revision as a final rule effective September 
13, 1995. However, the agency is giving interested persons 90 days to 
comment on this final rule.

II. Request for Comments

    Interested persons may, on or before July 20, 1995, submit to the 
Dockets Management Branch (address above) written comments regarding 
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.

 List of Subjects in 21 CFR Part 206

    Drugs.

PART 206--IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR 
HUMAN USE

    1. The authority citation for 21 CFR part 206 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 505, 507, 701 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 
355, 357, 371); sec. 351 of the Public Health Service Act (42 U.S.C. 
262).

    2. Section 206.10 is amended by revising the first sentence of 
paragraph (a) to read as follows:


Sec. 206.10  Code imprint required.

    (a) Unless exempted under Sec.  206.7, no drug product in solid 
oral dosage form may be introduced or delivered for introduction into 
interstate commerce unless it is clearly marked or imprinted with a 
code imprint that, in conjunction with the product's size, shape, and 
color, permits the unique identification of the drug product and the 
manufacturer or distributor of the product. * * *
* * * * *

     [[Page 19847]] Dated: April 13, 1995.
 William B. Schultz,
 Deputy Commissioner for Policy.
[FR Doc. 95-9951 Filed 4-20-95; 8:45 am]
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