1.This Act may be cited as the
Verifying Authority and Legality In
Drug Compounding Act of 2012
.
2.Application of
Federal law to practice of pharmacy compounding
(a)Section 503A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:
503A.
(a)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)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; updatesThe 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)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 agenciesUpon 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)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)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 prohibitedThe 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)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)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 waiverSubject 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
understandingThe 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)The
Secretary shall establish criteria and a process for determining whether to
authorize a State to grant waivers under paragraph (1).
(C)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)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)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 pharmacistsIn 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)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)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 prohibitedThe Secretary may not authorize any State to
grant waivers under this subsection.
(f)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)
(1)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 safetyThe Secretary may cancel a waiver
without regard to paragraph (1) in order to prevent an adverse impact on public
health or safety.
(h)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)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 deathIf 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)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)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)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)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)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)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.
3.Registration and
inspection of manufacturers compounding drug products
(a)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)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)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)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.