[Federal Register: January 3, 2008 (Volume 73, Number 2)]
[Rules and Regulations]
[Page 402-404]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03ja08-6]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 208, and 209
[Docket No. 2003N-0342]
RIN 0910-AC35
Toll-Free Number for Reporting Adverse Events on Labeling for
Human Drug Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Interim final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is issuing an interim
final rule to codify the provisions of the proposed rule entitled
``Toll-Free Number for Reporting Adverse Events on Labeling for Human
Drug Products'' (69 FR 21778, April 22, 2004) (the toll-free number
proposed rule or proposed rule) that, under the Food and Drug
Administration Amendments Act of 2007 (FDAAA), became effective by
operation of law on January 1, 2008. This interim final rule requires
the addition of a statement on the labeling of certain human drug
products for which an application is approved under the Federal Food,
Drug, and Cosmetic Act (the act). The added statement includes a toll-
free number and advises that the number is to be used only for
reporting side effects and is not intended for medical advice (the side
effects statement). As mandated by FDAAA, this interim final rule does
not apply to over-the-counter drug products approved as new drugs under
the act if the product packaging includes a manufacturer's or
distributor's toll-free number for reporting complaints.
DATES: Effective Date: This rule is effective January 1, 2008.
Compliance Date: The agency anticipates that affected entities,
including manufacturers, authorized dispensers, and pharmacies, will
need time to update labeling and systems to comply with the new
requirements. Therefore, FDA intends to exercise its enforcement
discretion and not take enforcement actions with regard to these
regulations until January 1, 2009.
FOR FURTHER INFORMATION CONTACT: Carol Drew, Center for Drug Evaluation
and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
SUPPLEMENTARY INFORMATION:
I. Background
On September 27, 2007, the President signed into law FDAAA (Public
Law 110-85). Among other things, FDAAA reauthorized the Best
Pharmaceuticals for Children Act (BPCA). When enacted in 2001, the BPCA
(Public Law 107-109) directed FDA to issue a final rule requiring the
labeling of each human drug product for which an application is
approved under section 505 of the act (21 U.S.C. 355) to include: (1) A
toll-free number maintained by FDA for the purpose of receiving reports
of adverse events regarding drugs and (2) a statement that the number
is to be used for reporting purposes only, not to receive medical
advice. Collectively, we refer to the toll-free number and reporting
statement as the ``side effects statement.'' The BPCA stated that the
final rule must reach the broadest consumer audience and minimize the
cost to the pharmacy profession.
As required, FDA issued a proposed rule entitled ``Toll-Free Number
for Reporting Adverse Events on Labeling for Human Drug Products'' (69
FR 21778, April 22, 2004). FDA received 22 comments on this proposed
rule and was in the process of analyzing the comments and conducting
research on consumer comprehension of the side effects statement when
FDAAA was enacted (see section IV of this document).
II. FDAAA Requirements
Section 502(f) of FDAAA states that ``the proposed rule * * *
`Toll-Free Number for Reporting Adverse Events on Labeling for Human
Drug Products' * * * shall take effect on January 1, 2008,'' unless FDA
issues a final rule before that date.
FDAAA mandates one change to the proposed rule. As described in
section III of this document, section 502(f)(2) of FDAAA states that
the toll-free number proposed rule shall not apply to over-the-counter
(OTC) drugs marketed with an application approved under section 505 of
the act (application OTC drug products) if these application OTC drug
products meet certain labeling requirements. (Neither the BPCA, the
proposed rule, nor this interim final rule addresses OTC drugs marketed
without approved applications.)
Because the agency's rulemaking process is ongoing, for the reasons
explained in section IV of this document, this interim rule codifies
the provisions of the proposed rule as modified by FDAAA. As mandated
by FDAAA, these provisions came into effect on January 1, 2008. The
agency is publishing this interim final rule to codify the modified
toll-free number proposed rule that has now come into effect.
[[Page 403]]
III. Description of the Interim Final Rule
Consistent with the mandates of the BPCA, FDA proposed to require
that the side effects statement be included in FDA-approved Medication
Guides for drug products approved under section 505 of the act. We also
proposed that the side effects statement be distributed with each
prescription drug product approved under section 505 of the act and
dispensed to consumers by pharmacies and authorized dispensers in an
outpatient setting. In addition, as described in the toll-free number
proposed rule, FDA interpreted the BPCA to apply to application OTC
drug products. Accordingly, FDA also proposed to require the side
effects statement in the labeling for application OTC drug products.
Section 502(f)(2) of FDAAA states that the proposed rule shall not
apply to a drug: (1) For which an application is approved under section
505 of the act; (2) that is not described under section 503(b)(1) of
the act (21 U.S.C. 353(b)(1)); and (3) the packaging of which includes
a toll-free number through which consumers can report complaints to the
manufacturer or distributor of the drug. This provision means that the
proposed rule as it has come into effect by operation of law in
accordance with FDAAA does not apply to an application OTC drug product
if the product's packaging includes a manufacturer's or distributor's
toll-free number for reporting complaints. Accordingly, this interim
final rule includes a modified Sec. 201.66(c)(5)(vii) reflecting the
change to the proposed rule mandated by FDAAA.
IV. Ongoing Research on the Side Effects Statement
FDA is in the process of conducting research on the wording of the
side effects statement published in the toll-free number proposed rule.
FDA initiated this research after reviewing the comments on the
proposed rule. Among the reasons cited in these comments for testing
the statement were: (1) To determine the best and most precise wording
for the statement; (2) to evaluate consumer comprehension of the
proposed statement; and (3) to address concerns that consumers who read
the statement will mistakenly call FDA in search of medical advice.
FDA designed a two-part study in response to these comments. Part
one consisted of focus groups held to narrow the field of potential
statement alternatives. This research was completed in 2006 (OMB
Control No. 0910-0497). The second part of this research is a labeling
comprehension experiment to be conducted over the Internet (OMB Control
No. 0910-0603). FDA plans to complete this research. Then, based on the
results of the data collected from the research and the comments
received on the proposed rule, the agency will determine whether to
finalize this interim final rule as published or to publish a final
rule that amends this interim final rule. The effective date and
implementation schedule for the final rule will be designed to minimize
the burden of any additional regulatory changes for affected entities
who must comply with this interim final rule.
V. Legal Authority
Section 502(f) of FDAAA states that the toll-free number proposed
rule shall take effect on January 1, 2008, unless the agency publishes
a final rule prior to that date. FDA determined that the research being
undertaken to inform the proposed side effects statement could not be
completed in time for FDA to publish a final rule prior to January 1,
2008, and that this research needed to be completed for the agency to
respond fully to the comments received on the toll-free number proposed
rule. Therefore, FDA did not publish a final rule before January 1,
2008, and the toll-free number proposed rule, as modified by FDAAA,
came into effect by operation of law on that date.
FDA has received comments on the proposed rule addressing issues
including the scope of the rule, the content and presentation of the
side effects statement, the reporting provisions, the costs and
benefits of the rule, implementation of the rule, and compliance with
it. As part of the final rulemaking that the agency will undertake
after completing the research on the side effects statement (see
section IV in this document), FDA will consider and address all
comments submitted to the docket for the toll-free number proposed
rule.
VI. Effective Date/Compliance Date
As mandated by FDAAA, the effective date of the interim final rule
is January 1, 2008. In the preamble to the toll-free number proposed
rule, the agency proposed that all manufacturers, dispensers and
pharmacies subject to the rule be in compliance not more than 1 year
after the effective date of the final rule. FDA explained that the
agency anticipated these entities would require time to update labeling
and systems to comply with the new requirements.
FDAAA does not address timing needs for affected entities to come
into compliance with the rule. The only change FDAAA makes to the
agency's proposal is to limit the scope of the proposed rule to make
the rule inapplicable to certain application OTC drug products.
Accordingly, FDA concludes that FDAAA was not intended to make any
other changes to the agency's proposal, including with regard to
addressing the anticipated needs of affected entities for time to come
into compliance with the rule.
FDA continues to anticipate that affected entities, including
manufacturers of drug products, authorized dispensers, and pharmacies,
will need time to update labeling and systems to comply with the new
requirements. Therefore, consistent with the agency's proposal, the
agency intends to exercise its enforcement discretion with regard to
these regulations until January 1, 2009. That is, the agency does not
intend to take enforcement action with regard to this interim final
rule before that date.
List of Subjects
21 CFR Part 201
Drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 208
Labeling, Prescription drugs, Reporting and recordkeeping
requirements.
21 CFR Part 209
Authorized dispensers, Drugs, Pharmacies, Prescription drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended as follows:
PART 201--LABELING
0
1. The authority citation for 21 CFR part 201 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
0
2. Amend Sec. 201.66 by adding two sentences at the end of paragraph
(c)(5)(vii) to read as follows:
Sec. 201.66 Format and content requirements for over-the-counter
(OTC) drug product labeling.
* * * * *
(c) * * *
(5) * * *
(vii) * * * For all OTC drug products under an approved drug
application whose packaging does not include a toll-free number through
which consumers can report complaints to the manufacturer or
distributor of the drug product, the following text shall
[[Page 404]]
immediately follow the subheading: ``[Bullet] side effects occur. You
may report side effects to FDA at 1-800-FDA-1088.'' The telephone
number must appear in a minimum 6-point bold letter height or type
size.
* * * * *
PART 208--MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
0
3. The authority citation for 21 CFR part 208 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,
360, 371, 374; 42 U.S.C. 262.
0
4. Amend Sec. 208.20 by adding paragraph (b)(7)(iii) to read as
follows:
Sec. 208.20 Content and format of a Medication Guide.
* * * * *
(b) * * *
(7) * * *
(iii) For drug products approved under section 505 of the act, the
following verbatim statement: ``Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-
1088.''
* * * * *
0
5. Add part 209 to read as follows:
PART 209--REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO
DISTRIBUTE A SIDE EFFECTS STATEMENT
Subpart A--General Provisions
Sec.
209.1 Scope and purpose.
209.2 Definitions.
Subpart B--Requirements
209.10 Content and format of the side effects statement.
209.11 Dispensing and distributing the side effects statement.
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 371; 42
U.S.C. 241.
Subpart A--General Provisions
Sec. 209.1 Scope and purpose.
(a) This part sets forth requirements for human prescription drug
products approved under section 505 of the Federal Food, Drug, and
Cosmetic Act and dispensed by authorized dispensers and pharmacies to
consumers. This part requires distribution of a side effects statement
and applies to new and refill prescriptions. This part is not intended
to apply to authorized dispensers dispensing or administering
prescription drug products to inpatients in a hospital or health care
facility under an order of a licensed practitioner, or as part of
supervised home health care.
(b) The purpose of providing the side effects statement is to
enable consumers to report side effects of prescription drug products
to FDA.
Sec. 209.2 Definitions.
For the purposes of this part, the following definitions apply:
Act means the Federal Food, Drug, and Cosmetic Act (sections 201-
907 (21 U.S.C. 301-397)).
Authorized dispenser means an individual licensed, registered, or
otherwise permitted by the jurisdiction in which the individual
practices to provide drug products on prescription in the course of
professional practice.
Consumer medication information means written information
voluntarily provided to consumers by dispensing pharmacists as part of
patient medication counseling activities.
Medication Guide means FDA-approved patient labeling conforming to
the specifications set forth in part 208 of this chapter and other
applicable regulations.
Pharmacy includes, but is not limited to, a retail, mail order,
Internet, hospital, university, or clinic pharmacy, or a public health
agency, regularly and lawfully engaged in dispensing prescription
drugs.
Side effects statement means the following verbatim statement:
``Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.''
Subpart B--Requirements
Sec. 209.10 Content and format of the side effects statement.
(a) Content. The side effects statement provided with each
prescription drug product approved under section 505 of the act must
read: ``Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.''
(b) Format. The side effects statement must be in a single, clear,
easy-to-read type style. The letter height or type size used for the
side effects statement in accordance with paragraphs (b)(1) and (b)(2)
of Sec. 209.11 must be no smaller than 6 points (1 point = 0.0138
inch). The letter height or type size for the side effects statement
under paragraphs (b)(3), (b)(4), and (b)(5) of Sec. 209.11 must be no
smaller than 10 points.
Sec. 209.11 Dispensing and distributing the side effects statement.
(a) Each authorized dispenser or pharmacy must distribute the side
effects statement with each prescription drug product approved under
section 505 of the act and dispensed. The side effects statement must
be distributed with new and refill prescriptions.
(b) An authorized dispenser or pharmacy must choose one or more of
the following options to distribute the side effects statement:
(1) Distribute the side effects statement on a sticker attached to
the unit package, vial, or container of the drug product;
(2) Distribute the side effects statement on a preprinted pharmacy
prescription vial cap;
(3) Distribute the side effects statement on a separate sheet of
paper;
(4) Distribute the side effects statement in consumer medication
information; or
(5) Distribute the appropriate FDA-approved Medication Guide that
contains the side effects statement.
Dated: December 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-25426 Filed 1-2-08; 8:45 am]
BILLING CODE 4160-01-S