[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6584 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 6584
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
compounding of drug products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 2, 2012
Mr. Markey (for himself, Mr. Cohen, Ms. Slaughter, Mr. Lynch, and Mr.
Olver) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to provide for the
compounding of drug products.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Verifying Authority and Legality In
Drug Compounding Act of 2012''.
SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF PHARMACY COMPOUNDING.
(a) Amendment.--Section 503A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:
``SEC. 503A. PHARMACY COMPOUNDING.
``(a) In General.--Sections 501(a)(2)(B) and 505 shall not apply
with respect to a drug product if each of the following applies:
``(1) The drug product is compounded for an identified
individual patient based on the receipt of--
``(A) a valid prescription order; or
``(B) a notation, approved by the prescribing
practitioner, on the prescription order that a
compounded product is necessary for the identified
patient.
``(2) The drug product is compounded by a licensed
pharmacist in a State-licensed pharmacy or a Federal facility,
or by a licensed physician, pursuant to such prescription order
or notation.
``(3) The drug product is compounded exclusively from--
``(A) ingredients that comply with the standards of
an applicable United States Pharmacopoeia or National
Formulary monograph; or
``(B) if such a monograph does not exist,
ingredients that are ingredients in a drug--
``(i) for which an approval of an
application filed under subsection (b) or (j)
of section 505 is in effect; or
``(ii) that may be lawfully marketed in the
United States without such an approval pursuant
to the definition of a new drug in section 201.
``(4) Any bulk substance used for purposes of compounding
the drug product--
``(A) is manufactured by an establishment that is
registered under section 510 (including a foreign
establishment that is registered under section 510(i));
and
``(B) is accompanied by valid certificates of
analysis.
``(5) The pharmacist or physician compounding the drug
product complies with the standards of any applicable United
States Pharmacopoeia chapters on pharmacy compounding.
``(6) The drug product, including the dosage form and any
ingredient thereof, is not included in the list under
subsection (b).
``(7) The drug product is not a copy of a commercially
available drug.
``(b) List of Drug Products That Should Not Be Compounded.--
``(1) In general.--For purposes of subsection (a)(6), the
Secretary shall--
``(A) develop and maintain a list of drug products
that should not be compounded, including any
categories, dosage forms, or ingredients of such drug
products; and
``(B) include on such list, at a minimum--
``(i) drug products (or categories, dosage
forms, or ingredients thereof) whose
compounding is reasonably likely to cause an
adverse effect on safety or effectiveness of
such drug product; and
``(ii) drug products (or categories, dosage
forms, or ingredients thereof) that have been
withdrawn or removed from the market because
they have been found to be unsafe or not
effective.
``(2) Initial publication; updates.--The Secretary shall--
``(A) not later than 1 year after the date of the
enactment of the Verifying Authority and Legality In
Drug Compounding Act of 2012, publish an initial list
under paragraph (1); and
``(B) not less frequently than every year
thereafter, review and, as appropriate, update the list
under paragraph (1).
``(3) Availability.--The Secretary shall make the list
under paragraph (1) available on the public Web site of the
Food and Drug Administration.
``(4) Transmission to state regulatory agencies.--Upon
publication of the initial list under paragraph (1), and upon
each update to the list, the Secretary shall transmit an up-to-
date copy of the list to the agency in each State with primary
responsibility for regulating the compounding of drugs.
``(c) Waiver of Requirement of Individually Identified Patient for
Specified Drug Products.--
``(1) Waiver authority.--The Secretary may, with respect to
a drug product sold or dispensed by a pharmacy or pharmacist,
waive the requirement of subsection (a)(1) that the drug
product be compounded for an individually identified patient if
the Secretary determines that compounding the drug product is
necessary--
``(A) to address a drug shortage; or
``(B) to protect public health or well-being.
``(2) Duration.--The duration of a waiver under paragraph
(1) shall not exceed 1 year, unless the Secretary determines
that an extension is necessary to continue--
``(A) to address the drug shortage for which such
waiver was originally approved; or
``(B) to protect public health or well-being.
``(3) Waivers by states prohibited.--The Secretary may not
authorize any State to grant waivers under this subsection.
``(d) Waiver of Requirement of Individually Identified Patient for
Specified Pharmacies and Pharmacists.--
``(1) Waiver authority.--The Secretary may waive the
requirement of subsection (a)(1) that the drug product be
compounded for an individually identified patient if the
pharmacy or pharmacist--
``(A) submits an application that meets the
requirements of paragraph (5)(A) and is satisfactory to
the Secretary (or, subject to paragraph (3), the
State); and
``(B) agrees to comply with any condition of
operation and any limitations specified by the
Secretary as a requirement for such waiver, including
the conditions and limitations specified under
paragraph (5).
``(2) Ineligible pharmacies.--A pharmacy or pharmacist
required to be registered under section 510 for purposes of
compounding a drug product is not eligible for a waiver under
this subsection for such purposes.
``(3) Types of pharmacies eligible for waiver.--Subject to
paragraph (2), the Secretary shall specify types of pharmacies
and pharmacists that are eligible for a waiver under this
subsection, and shall include the following types:
``(A) Any pharmacy or pharmacist within a hospital
system that is compounding drug products exclusively
for dispensing to patients within that hospital system.
``(B) Any pharmacy or pharmacist that compounds
sterile drug products.
``(C) Any pharmacy or pharmacist that compounds
drug products in limited quantities before the receipt
of a valid prescription for an individual patient who
is located in the same State as the pharmacy or
pharmacist, based on a history of the pharmacy or
pharmacist receiving such valid prescription.
``(4) Waivers by states allowed.--
``(A) Memorandum of understanding.--The Secretary
may authorize a State to grant waivers under paragraph
(1) to pharmacies and pharmacists in such State
pursuant to a memorandum of understanding entered into
between the Secretary and the State--
``(i) ensuring, to the Secretary's
satisfaction, that the State's program for
granting waivers will be implemented in
accordance with the requirements of this
section (including the application of different
requirements for different types of pharmacies,
as specified under paragraph (5)(B)); and
``(ii) including such other information and
assurances as the Secretary may require.
``(B) Determination.--The Secretary shall establish
criteria and a process for determining whether to
authorize a State to grant waivers under paragraph (1).
``(C) Scope of authorization.--In authorizing a
State to grant waivers under subparagraph (A), the
Secretary may limit such authority to apply only with
respect to certain types of pharmacies and pharmacists
specified under paragraph (3).
``(D) Limitation.--A waiver granted by a State to a
pharmacy or pharmacist under subparagraph (A) shall
only apply with respect to compounded drug products
sold or dispensed within such State.
``(5) Applications; requirements.--
``(A) In general.--For each type of pharmacy or
pharmacist specified under paragraph (3), the Secretary
shall specify, in the regulations under subsection (j),
the following:
``(i) The information that is required to
be included in an application for a waiver
under paragraph (1).
``(ii) The circumstances necessary to
support the approval of such an application by
the Secretary, or by a State that is authorized
to grant waivers under paragraph (4), including
the criteria that shall be used to evaluate
such an application.
``(iii) The conditions of operation,
including good manufacturing practices and
requirements for third-party testing,
applicable to the compounding of drugs under
such a waiver.
``(iv) Any limitations on the activities
that a pharmacy or pharmacist may engage in
under such a waiver.
``(v) The duration (and renewability) of
such a waiver.
``(B) Specificity to types of pharmacies and
pharmacists.--In establishing requirements under
subparagraph (A), the Secretary shall make the
requirements specific to each type of pharmacy and
pharmacist specified by the Secretary under paragraph
(3).
``(e) Waiver of Requirement Regarding Copies of Commercially
Available Drug.--
``(1) Waiver authority.--The Secretary may, with respect to
a drug product sold or dispensed by a pharmacy or pharmacist,
waive the requirement of subsection (a)(7) if the Secretary
determines that compounding the drug product is necessary to
protect public health or well-being.
``(2) Duration.--The duration of a waiver under paragraph
(1) shall not exceed 1 year, unless the Secretary determines
that an extension is necessary to protect public health or
well-being.
``(3) Waivers by states prohibited.--The Secretary may not
authorize any State to grant waivers under this subsection.
``(f) Inspections.--The facilities of any pharmacy or pharmacist
compounding drug products pursuant to a waiver under subsection (c),
(d), or (e) shall be subject to inspection under section 704 for
purposes of determining compliance with the provisions of this Act
applicable to such compounding.
``(g) Cancellation of Waiver.--
``(1) In general.--The Secretary shall publish notice at
least 30 days before cancelling a waiver under subsection (c),
(d), or (e).
``(2) Exception for public health and safety.--The
Secretary may cancel a waiver without regard to paragraph (1)
in order to prevent an adverse impact on public health or
safety.
``(h) Labeling.--The labeling of any drug product compounded
pursuant to subsection (a) shall include the following statement: `This
drug has not been tested for safety and effectiveness and is not
approved by the FDA. Serious adverse reactions to this drug should be
reported to the pharmacy where it was received and the FDA at _____.'
The blank shall specify a phone number and a Web site, to be provided
by the Secretary for purposes of this subsection.
``(i) Reporting by Pharmacists and Physicians.--
``(1) Adverse event.--If a pharmacist or physician
compounding a drug product pursuant to this section becomes
aware of any adverse event associated with the use of such
product, not later than 10 calendar days after becoming so
aware, the pharmacist or physician shall report such adverse
event to the Secretary.
``(2) Information related to risk of injury or death.--If a
pharmacist or physician compounding a drug product pursuant to
this section becomes aware of information concerning any
bacteriological, fungal, or other contamination; any
significant chemical, physical, or other change; or any
deterioration of a compounded drug product that has already
been distributed by the pharmacist or physician, that could
cause serious injury or death, not later than 5 calendar days
after becoming so aware, the pharmacist or physician shall
report such information to the Secretary.
``(j) Regulations.--The Secretary shall promulgate regulations for
carrying out this section, which shall include the following:
``(1) The types of pharmacies and pharmacists specified
pursuant to subsection (d)(3).
``(2) The criteria and process for determining whether a
State may provide a waiver under subsection (d)(4).
``(3) The information specified under subsection (d)(5)(A).
``(4) The requirements applicable to different types of
pharmacies and pharmacists under subsection (d)(5).
``(5) The requirements for inspections under subsection
(f).
``(k) Definitions.--In this section:
``(1) The term `copy of a commercially available drug
product' does not include a drug product in which there is a
change, made for an identified individual patient, which
produces for that patient a significant difference, as
determined by the prescribing practitioner, between the
compounded drug and the comparable commercially available drug
product.
``(2) The term `compounding' does not include mixing,
reconstituting, or other such acts that are performed in
accordance with directions contained in approved labeling
provided by the product's manufacturer and other manufacturer
directions consistent with that labeling.''.
(b) 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:
``(bb) If it is a drug product compounded pursuant to section 503A
and its labeling does not include the statement required by section
503A(h).''.
(c) Conforming Amendment.--Section 704(a)(2)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)(A)) is amended by
inserting ``subject to section 503A,'' before ``pharmacies which
maintain establishments''.
(d) Regulations.--Not later than 1 year after the date of the
enactment of this Act, the Secretary shall promulgate final regulations
for carrying out the amendments made by subsections (a), (b), and (c).
(e) Effective Date.--The amendments made by subsections (a), (b),
and (c) shall take effect on the date that is 1 year after the date of
the enactment of this Act.
SEC. 3. REGISTRATION AND INSPECTION OF MANUFACTURERS COMPOUNDING DRUG
PRODUCTS.
(a) Registration.--Section 510(g) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(g)) is amended by adding at the end the
following: ``With respect to compounding drugs, the exemption in
paragraph (1) does not apply with respect to any pharmacy to the extent
to which the pharmacy is, in effect, manufacturing such drugs, as
determined by the Secretary, taking into consideration the extent to
which such pharmacy sells the drugs across State lines, the quantity of
the drugs sold, and any other factors determined appropriate by the
Secretary.''.
(b) Inspection.--Section 704(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374(a)(2)) is amended by adding at the end the
following flush text:
``With respect to compounding drugs, the exemption in
subparagraph (A) does not apply with respect to any pharmacy to
the extent to which the pharmacy is, in effect, manufacturing
such drugs, as determined by the Secretary, taking into
consideration the extent to which such pharmacy sells the drugs
across State lines, the quantity of the drugs sold, and any
other factors determined appropriate by the Secretary.''.
(c) Regulations.--Not later than 1 year after the date of the
enactment of this Act, the Secretary of Health and Human Services shall
promulgate regulations for carrying out the amendments made by
subsections (a) and (b).
(d) Effective Date.--The amendment made by subsection (a) shall
take effect on the date that is 1 year after the date of the enactment
of this Act.
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