[109th Congress Public Law 462]
[From the U.S. Government Printing Office]
[DOCID: f:publ462.109]
[[Page 120 STAT. 3469]]
Public Law 109-462
109th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act with respect to
serious adverse event reporting for dietary supplements and
nonprescription drugs, and for other purposes. <<NOTE: Dec. 22,
2006 - [S. 3546]>>
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, <<NOTE: Dietary
Supplement and Nonprescription Drug Consumer Protection Act.>>
SECTION 1. <<NOTE: 21 USC 301 note.>> SHORT TITLE.
This Act may be cited as the ``Dietary Supplement and
Nonprescription Drug Consumer Protection Act''.
SEC. 2. SERIOUS ADVERSE EVENT REPORTING FOR NONPRESCRIPTION DRUGS.
(a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the
following:
``Subchapter H--Serious Adverse Event Reports
``SEC. 760. <<NOTE: 21 USC 379aa.>> SERIOUS ADVERSE EVENT REPORTING FOR
NONPRESCRIPTION DRUGS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a
nonprescription drug that is adverse, including--
``(A) an event occurring from an overdose of the
drug, whether accidental or intentional;
``(B) an event occurring from abuse of the drug;
``(C) an event occurring from withdrawal from the
drug; and
``(D) any failure of expected pharmacological action
of the drug.
``(2) Nonprescription drug.--The term `nonprescription drug'
means a drug that is--
``(A) not subject to section 503(b); and
``(B) not subject to approval in an application
submitted under section 505.
``(3) Serious adverse event.--The term `serious adverse
event' is an adverse event that--
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability
or incapacity; or
[[Page 120 STAT. 3470]]
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical
judgment, a medical or surgical intervention to prevent
an outcome described under subparagraph (A).
``(4) Serious adverse event report.--The term `serious
adverse event report' means a report that is required to be
submitted to the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor
whose name (pursuant to section 502(b)(1)) appears on the label
of a nonprescription drug marketed in the United States
(referred to in this section as the `responsible person') shall
submit to the Secretary any report received of a serious adverse
event associated with such drug when used in the United States,
accompanied by a copy of the label on or within the retail
package of such drug.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by agreement,
authorize the manufacturer or packer of the nonprescription drug
to submit the required reports for such drugs to the Secretary
so long as the retailer directs to the manufacturer or packer
all adverse events associated with such drug that are reported
to the retailer through the address or telephone number
described in section 502(x).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall
submit to the Secretary a serious adverse event report no later
than 15 business days after the report is received through the
address or phone number described in section 502(x).
``(2) New medical information.--The responsible person shall
submit to the Secretary any new medical information, related to
a submitted serious adverse event report that is received by the
responsible person within 1 year of the initial report, no later
than 15 business days after the new information is received by
the responsible person.
``(3) Consolidation of reports.--The Secretary shall develop
systems to ensure that duplicate reports of, and new medical
information related to, a serious adverse event shall be
consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and
an opportunity for comment from interested parties, may
establish an exemption to the requirements under paragraphs (1)
and (2) if the Secretary determines that such exemption would
have no adverse effect on public health.
``(d) Contents of Reports.--Each serious adverse event report under
this section shall be submitted to the Secretary using the MedWatch
form, which may be modified by the Secretary for nonprescription drugs,
and may be accompanied by additional information.
``(e) Maintenance and Inspection of Records.--
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received by
the responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall
permit an authorized person to have access to records
required
[[Page 120 STAT. 3471]]
to be maintained under this section, during an
inspection pursuant to section 704.
``(B) Authorized person.--For purposes of this
paragraph, the term `authorized person' means an officer
or employee of the Department of Health and Human
Services who has--
``(i) appropriate credentials, as determined
by the Secretary; and
``(ii) been duly designated by the Secretary
to have access to the records required under this
section.
``(f) Protected Information.--A serious adverse event report
submitted to the Secretary under this section, including any new medical
information submitted under subsection (c)(2), or an adverse event
report voluntarily submitted to the Secretary shall be considered to
be--
``(1) a safety report under section 756 and may be
accompanied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
``(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the
`Privacy Act of 1974') and a medical or similar file the
disclosure of which would constitute a violation of section 552
of such title 5 (commonly referred to as the `Freedom of
Information Act'), and shall not be publicly disclosed unless
all personally identifiable information is redacted.
``(g) Rule of Construction.--The submission of any adverse event
report in compliance with this section shall not be construed as an
admission that the nonprescription drug involved caused or contributed
to the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall
establish or continue in effect any law, regulation, order, or
other requirement, related to a mandatory system for adverse
event reports for nonprescription drugs, that is different from,
in addition to, or otherwise not identical to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall
affect the authority of the Secretary to provide adverse
event reports and information to any health, food, or
drug officer or employee of any State, territory, or
political subdivision of a State or territory, under a
memorandum of understanding between the Secretary and
such State, territory, or political subdivision.
``(B) Personally-identifiable information.--
Notwithstanding any other provision of law, personally-
identifiable information in adverse event reports
provided by the Secretary to any health, food, or drug
officer or employee of any State, territory, or
political subdivision of a State or territory, shall
not--
``(i) be made publicly available pursuant to
any State or other law requiring disclosure of
information or records; or
``(ii) otherwise be disclosed or distributed
to any party without the written consent of the
Secretary
[[Page 120 STAT. 3472]]
and the person submitting such information to the
Secretary.
``(C) Use of safety reports.--Nothing in this
section shall permit a State, territory, or political
subdivision of a State or territory, to use any safety
report received from the Secretary in a manner
inconsistent with subsection (g) or section 756.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary.''.
(b) Modifications.--The <<NOTE: 21 USC 379aa note.>> Secretary of
Health and Human Services may modify requirements under the amendments
made by this section in accordance with section 553 of title 5, United
States Code, to maintain consistency with international harmonization
efforts over time.
(c) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 704(a);'' and inserting ``, 704(a), or
760;''; and
(2) striking ``, or 564'' and inserting ``, 564, or 760''.
(d) Misbranding.--Section 502 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the
following:
``(x) If it is a nonprescription drug (as defined in section 760)
that is marketed in the United States, unless the label of such drug
includes a domestic address or domestic phone number through which the
responsible person (as described in section 760) may receive a report of
a serious adverse event (as defined in section 760) with such drug.''.
(e) Effective Dates.--
(1) In general.--Except <<NOTE: 21 USC 352 note.>> as
provided in paragraph (2), the amendments made by this section
shall take effect 1 year after the date of enactment of this
Act.
(2) Misbranding.--Section 502(x) of the Federal Food, Drug,
and Cosmetic Act (as added by this section) shall apply to any
nonprescription drug (as defined in such section 502(x)) labeled
on or after the date that is 1 year after the date of enactment
of this Act.
(3) Guidance.--Not <<NOTE: 21 USC 379aa note.>> later than
270 days after the date of enactment of this Act, the Secretary
of Health and Human Services shall issue guidance on the minimum
data elements that should be included in a serious adverse event
report described under the amendments made by this Act.
SEC. 3. SERIOUS ADVERSE EVENT REPORTING FOR DIETARY SUPPLEMENTS.
(a) In General.--Chapter VII of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 371 et seq.) is amended by adding at the end the
following:
``SEC. 761. <<NOTE: 21 USC 379aa-1.>> SERIOUS ADVERSE EVENT REPORTING
FOR DIETARY SUPPLEMENTS.
``(a) Definitions.--In this section:
``(1) Adverse event.--The term `adverse event' means any
health-related event associated with the use of a dietary
supplement that is adverse.
``(2) Serious adverse event.--The term `serious adverse
event' is an adverse event that--
[[Page 120 STAT. 3473]]
``(A) results in--
``(i) death;
``(ii) a life-threatening experience;
``(iii) inpatient hospitalization;
``(iv) a persistent or significant disability
or incapacity; or
``(v) a congenital anomaly or birth defect; or
``(B) requires, based on reasonable medical
judgment, a medical or surgical intervention to prevent
an outcome described under subparagraph (A).
``(3) Serious adverse event report.--The term `serious
adverse event report' means a report that is required to be
submitted to the Secretary under subsection (b).
``(b) Reporting Requirement.--
``(1) In general.--The manufacturer, packer, or distributor
of a dietary supplement whose name (pursuant to section
403(e)(1)) appears on the label of a dietary supplement marketed
in the United States (referred to in this section as the
`responsible person') shall submit to the Secretary any report
received of a serious adverse event associated with such dietary
supplement when used in the United States, accompanied by a copy
of the label on or within the retail packaging of such dietary
supplement.
``(2) Retailer.--A retailer whose name appears on the label
described in paragraph (1) as a distributor may, by agreement,
authorize the manufacturer or packer of the dietary supplement
to submit the required reports for such dietary supplements to
the Secretary so long as the retailer directs to the
manufacturer or packer all adverse events associated with such
dietary supplement that are reported to the retailer through the
address or telephone number described in section 403(y).
``(c) Submission of Reports.--
``(1) Timing of reports.--The responsible person shall
submit to the Secretary a serious adverse event report no later
than 15 business days after the report is received through the
address or phone number described in section 403(y).
``(2) New medical information.--The responsible person shall
submit to the Secretary any new medical information, related to
a submitted serious adverse event report that is received by the
responsible person within 1 year of the initial report, no later
than 15 business days after the new information is received by
the responsible person.
``(3) Consolidation of reports.--The Secretary shall develop
systems to ensure that duplicate reports of, and new medical
information related to, a serious adverse event shall be
consolidated into a single report.
``(4) Exemption.--The Secretary, after providing notice and
an opportunity for comment from interested parties, may
establish an exemption to the requirements under paragraphs (1)
and (2) if the Secretary determines that such exemption would
have no adverse effect on public health.
``(d) Contents of Reports.--Each serious adverse event report under
this section shall be submitted to the Secretary using the MedWatch
form, which may be modified by the Secretary for dietary supplements,
and may be accompanied by additional information.
``(e) Maintenance and Inspection of Records.--
[[Page 120 STAT. 3474]]
``(1) Maintenance.--The responsible person shall maintain
records related to each report of an adverse event received by
the responsible person for a period of 6 years.
``(2) Records inspection.--
``(A) In general.--The responsible person shall
permit an authorized person to have access to records
required to be maintained under this section during an
inspection pursuant to section 704.
``(B) Authorized person.--For purposes of this
paragraph, the term `authorized person' means an officer
or employee of the Department of Health and Human
Services, who has--
``(i) appropriate credentials, as determined
by the Secretary; and
``(ii) been duly designated by the Secretary
to have access to the records required under this
section.
``(f) Protected Information.--A serious adverse event report
submitted to the Secretary under this section, including any new medical
information submitted under subsection (c)(2), or an adverse event
report voluntarily submitted to the Secretary shall be considered to
be--
``(1) a safety report under section 756 and may be
accompanied by a statement, which shall be a part of any report
that is released for public disclosure, that denies that the
report or the records constitute an admission that the product
involved caused or contributed to the adverse event; and
``(2) a record about an individual under section 552a of
title 5, United States Code (commonly referred to as the
`Privacy Act of 1974') and a medical or similar file the
disclosure of which would constitute a violation of section 552
of such title 5 (commonly referred to as the `Freedom of
Information Act'), and shall not be publicly disclosed unless
all personally identifiable information is redacted.
``(g) Rule of Construction.--The submission of any adverse event
report in compliance with this section shall not be construed as an
admission that the dietary supplement involved caused or contributed to
the adverse event.
``(h) Preemption.--
``(1) In general.--No State or local government shall
establish or continue in effect any law, regulation, order, or
other requirement, related to a mandatory system for adverse
event reports for dietary supplements, that is different from,
in addition to, or otherwise not identical to, this section.
``(2) Effect of section.--
``(A) In general.--Nothing in this section shall
affect the authority of the Secretary to provide adverse
event reports and information to any health, food, or
drug officer or employee of any State, territory, or
political subdivision of a State or territory, under a
memorandum of understanding between the Secretary and
such State, territory, or political subdivision.
``(B) Personally-identifiable information.--
Notwithstanding any other provision of law, personally-
identifiable information in adverse event reports
provided by the Secretary to any health, food, or drug
officer or employee of any State, territory, or
political subdivision of a State or territory, shall
not--
[[Page 120 STAT. 3475]]
``(i) be made publicly available pursuant to
any State or other law requiring disclosure of
information or records; or
``(ii) otherwise be disclosed or distributed
to any party without the written consent of the
Secretary and the person submitting such
information to the Secretary.
``(C) Use of safety reports.--Nothing in this
section shall permit a State, territory, or political
subdivision of a State or territory, to use any safety
report received from the Secretary in a manner
inconsistent with subsection (g) or section 756.
``(i) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be necessary.''.
(b) Prohibited Act.--Section 301(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(e)) is amended by--
(1) striking ``, or 760;'' and inserting ``, 760, or 761;'';
and
(2) striking ``, or 760'' and inserting ``, 760, or 761''.
(c) Misbranding.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following:
``(y) If it is a dietary supplement that is marketed in the United
States, unless the label of such dietary supplement includes a domestic
address or domestic phone number through which the responsible person
(as described in section 761) may receive a report of a serious adverse
event with such dietary supplement.''.
(d) Effective Date.--
(1) In general.--Except <<NOTE: 21 USC 343 note.>> as
provided in paragraph (2), the amendments made by this section
shall take effect 1 year after the date of enactment of this
Act.
(2) Misbranding.--Section 403(y) of the Federal Food, Drug,
and Cosmetic Act (as added by this section) shall apply to any
dietary supplement labeled on or after the date that is 1 year
after the date of enactment of this Act.
(3) Guidance.--Not <<NOTE: 21 USC 379aa note.>> later than
270 days after the date of enactment of this Act, the Secretary
of Health and Human Services shall issue guidance on the minimum
data elements that should be included in a serious adverse event
report as described under the amendments made by this Act.
SEC. 4. PROHIBITION OF FALSIFICATION OF REPORTS.
(a) In General.--Section 301 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 331) is amended by adding at the end the following:
``(ii) The falsification of a report of a serious adverse event
submitted to a responsible person (as defined under section 760 or 761)
or the falsification of a serious adverse event report (as defined under
section 760 or 761) submitted to the Secretary.''.
(b) Effective Date.--The <<NOTE: 21 USC 331 note.>> amendment made
by this section shall take effect 1 year after the date of enactment of
this Act.
SEC. 5. IMPORTATION OF CERTAIN NONPRESCRIPTION DRUGS AND DIETARY
SUPPLEMENTS.
(a) In General.--Section 801 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 381) is amended--
(1) in subsection (a), by inserting after the third sentence
the following: ``If such article is subject to a requirement
under
[[Page 120 STAT. 3476]]
section 760 or 761 and if the Secretary has credible evidence or
information indicating that the responsible person (as defined
in such section 760 or 761) has not complied with a requirement
of such section 760 or 761 with respect to any such article, or
has not allowed access to records described in such section 760
or 761, then such article shall be refused admission, except as
provided in subsection (b) of this section.''; and
(2) in the second sentence of subsection (b)--
(A) by inserting ``(1)'' before ``an article
included'';
(B) by inserting before ``final determination'' the
following: ``or (2) with respect to an article included
within the provision of the fourth sentence of
subsection (a), the responsible person (as defined in
section 760 or 761) can take action that would assure
that the responsible person is in compliance with
section 760 or 761, as the case may be,''; and
(C) by inserting ``, or, with respect to clause (2),
the responsible person,'' before ``to perform''.
(b) Effective Date.--The <<NOTE: 21 USC 381 note.>> amendments made
by this section shall take effect 1 year after the date of enactment of
this Act.
Approved December 22, 2006.
LEGISLATIVE HISTORY--S. 3546:
---------------------------------------------------------------------------
SENATE REPORTS: No. 109-324 (Comm. on Health, Education, Labor, and
Pensions).
CONGRESSIONAL RECORD, Vol. 152 (2006):
Dec. 6, considered and passed Senate.
Dec. 8, considered and passed House.
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