[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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