[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6638 Introduced in House (IH)]
112th CONGRESS
2d Session
H. R. 6638
To amend chapter V of the Federal Food, Drug, and Cosmetic Act to
enhance the requirements for pharmacies that compound drug products.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 5, 2012
Ms. DeLauro (for herself and Mrs. Lowey) introduced the following bill;
which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend chapter V of the Federal Food, Drug, and Cosmetic Act to
enhance the requirements for pharmacies that compound 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 ``Supporting Access to Formulated and
Effective Compounded Drugs Act of 2012'' or the ``S.A.F.E. Compounded
Drugs Act of 2012''.
SEC. 2. ENHANCED REQUIREMENTS FOR COMPOUNDED DRUGS.
(a) In General.--Section 503A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353a) is amended--
(1) in subsection (a)(1)(A), by inserting ``that is
registered with the Secretary under subsection (b)(6) (or is
subject to the exception under subsection (b)(6)(C))'' after
``State licensed pharmacy'';
(2) in subsection (b)--
(A) in paragraph (1)(D), by striking ``regularly or
in inordinate amounts (as defined by the Secretary)'';
and
(B) by adding at the end the following:
``(4) Notification.--
``(A) Prescriber notification.--Before providing a
prescription order for a drug to be compounded under
subsection (a), the physician or other licensed
practitioner who will write such order shall--
``(i) inform the individual patient for
whom such order is being written that a
compounded drug is being prescribed; and
``(ii) provide such patient with a written
document containing information concerning the
availability, safety, and production of
compounded drugs.
``(B) Confirmation by pharmacist.--Except in the
case of a compounded drug product used in a procedure
described in subparagraph (C), a licensed pharmacist or
licensed physician who dispenses a compounded drug
under subsection (a) shall, at the time such drug is
dispensed--
``(i) confirm that the patient (or the
individual to whom the drug is delivered on
behalf of the patient) understands that the
drug is a compounded drug; and
``(ii) provide a written document
containing the information described in
subparagraph (A)(ii).
``(C) Provider notification.--Prior to providing a
health care service that will be conducted by a health
care provider in a health care setting (such as a
hospital or a physician's office) and during which
service a drug compounded under subsection (a) will be
administered to a patient for purposes of treating such
patient, the health care provider shall--
``(i) inform the patient that a compounded
drug will be used during the procedure; and
``(ii) provide such patient with a written
document containing the information described
in subparagraph (A)(ii).
``(5) Labeling.--
``(A) In general.--A drug product compounded under
subsection (a) shall be clearly labeled as a `non-FDA
approved compounded drug product'.
``(B) Development of requirements.--In determining
the requirements for the label under subparagraph (A),
the Secretary--
``(i) shall establish, and consult with, a
temporary advisory committee on compounded drug
product labeling requirements; and
``(ii) may establish different labeling
requirements for--
``(I) a compounded drug product
intended for use by a health care
provider in an office or treatment
setting; and
``(II) a compounded drug product
intended for any use not described in
subclause (I).
``(6) Registration.--
``(A) Establishment of process.--The Secretary, in
consultation with experts and representatives of
stakeholders including pharmacies, compounding
pharmacies, State regulators, and health care
providers, shall establish a process for pharmacies
described in subsection (a)(1)(A) to register as a
compounding pharmacy. Such registration shall be
conducted through an electronic method.
``(B) Registration requirement.--Except as provided
in subparagraph (C), in order to be registered with the
Secretary for purposes of subsection (a)(1)(A), every
person who owns or operates a pharmacy shall submit to
the Secretary, in such time and manner as the Secretary
may require--
``(i) contact information for the pharmacy;
``(ii) the State or States that the
pharmacy is licensed in;
``(iii) the methods used by the facility in
compounding; and
``(iv) any additional information required
by the Secretary, which may include the
quantity of product compounded at such pharmacy
for the purpose of determining if a drug
manufacturing facility is inappropriately
registering as a compounding pharmacy.
``(C) Exception.--A pharmacy shall be exempt from
the requirement to register under subsection (a)(1)(A)
if the pharmacy--
``(i) employs fewer than 20 full-time
employees (or 20 full-time equivalents); and
``(ii) performs traditional compounding of
drug products for use in a single State.''; and
(3) by adding at the end the following:
``(g) Database.--
``(1) In general.--The Secretary shall establish and
maintain a database of information on pharmacies compounding
drug products under subsection (a) that are licensed in more
than one State, including--
``(A) the minimum standards for a compounding
pharmacy license in each State;
``(B) relevant information provided to the
Secretary by State agencies that regulate pharmacies;
and
``(C) other information determined relevant by the
Secretary.
``(2) Design.--The database under paragraph (1)--
``(A) shall be accessible, as determined
appropriate by the Secretary, to State agencies that
regulate pharmacies that compound drug products;
``(B) shall enable States and the Secretary to
share information to ensure appropriate oversight of
pharmacies that compound drug products; and
``(C) shall be used by the Secretary to inform the
Federal inspection and oversight of pharmacies that
compound drug products to ensure that issues and
pharmacies identified in the database receive
appropriate oversight.
``(h) Minimum Standards.--
``(1) The Secretary shall establish minimum standards for
the safe production of compounded drug products.
``(2) The Secretary shall determine these minimum standards
and shall determine the drug products that must meet the
minimum standards.
``(3) The standards may include but is not limited to the
intended route of administration and if the drug is sterile or
non-sterile. If appropriate, the Secretary may consider the
different types of drug products and set appropriate minimum
standards for specific drug types or drug uses.
``(i) Training.--The Secretary shall conduct a series of regional
training opportunities for State agencies that regulate pharmacies that
compound drug products. These training opportunities should include
information on the minimum standards discussed in (h), sample
inspection protocol, and recordkeeping to facilitate the inclusion of
State findings and inspections into the database discussed in (g).''.
(b) Deadlines and Advisory Committees.--
(1) Deadline for issuance of regulations.--Not later than
18 months after the date of enactment of this Act, the
Secretary of Health and Human Services shall issue regulations
to implement--
(A) paragraphs (4) and (5) of section 503A(b) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (a); and
(B) subsection (g) of section 503A of such Act.
(2) Labeling advisory committee.--
(A) Establishment.--The Secretary of Health and
Human Services shall establish an advisory committee on
labeling (as defined in section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321)) of
compounded drug products and shall consult such
committee in the development of the regulations under
paragraph (1)(A).
(B) Membership.--The advisory committee shall
include representatives of patients or consumers,
health care providers, compounding pharmacies, State
agencies that regulate compounding pharmacies, and at
least one member with expertise on clearly
communicating information in such labeling of drugs.
(C) Meetings.--The advisory committee shall hold an
initial meeting not later than 6 months after the date
of enactment of this Act.
(D) Recommendations.--Not later than 12 months
after the date of enactment of this Act, the advisory
committee shall submit to the Secretary of Health and
Human Services recommendations on the regulations under
paragraph (1)(A), including recommendations on the type
of information and language that should be included on
the labels of drug products that are compounded
pursuant to section 503A of the Federal Food, Drug, and
Cosmetic Act.
(E) Termination.--The advisory committee under this
subparagraph shall terminate upon the submission of the
recommendations under subparagraph (D).
(3) Database advisory committee.--
(A) Establishment.--The Secretary of Health and
Human Services shall establish an advisory committee on
the database described in section 503A(g) of the
Federal Food, Drug, and Cosmetic Act, as added by
subsection (a), and shall consult such committee in the
development of the regulations under paragraph (1)(B).
(B) Membership.--The advisory committee shall
include representatives of patients or consumers,
health care providers, compounding pharmacies, State
agencies that regulate compounding pharmacies, and
information technology experts.
(C) Meetings.--The advisory committee shall hold an
initial meeting not later than 6 months after the date
of enactment of this Act.
(D) Recommendations.--Not later than 12 months
after the date of enactment of this Act, the advisory
committee shall submit to the Secretary of Health and
Human Services recommendations on the regulations under
paragraph (1)(B).
(E) Termination.--The advisory committee under this
subparagraph shall terminate upon the submission of the
recommendations under subparagraph (D).
(4) Permanent advisory committee on pharmacy compounding.--
The Secretary shall convene the Advisory Committee on Pharmacy
Compounding as appropriate to consider issues related to the
safety and availability of compounded drug products.
SEC. 3. REPORTS AND STUDIES.
(a) Biannual Reports.--Not later than 6 months after the date of
enactment of this Act, and at the end of each succeeding 6-month period
that ends before the 25th month after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit to the
Congress a report on the status of the implementation of the
requirements of this Act, and the amendments made by this Act.
(b) Third-Party Accreditation.--Not later than 12 months after the
date of enactment of this Act, the Secretary shall submit to the
Congress a report that contains--
(1) a review of the standards used by organizations that
provide accreditation to compounding pharmacies; and
(2) an evaluation of the effectiveness of such standards in
ensuring the production of safe and effective compounded drug
products.
(c) Structure of State Oversight.--Not later than 18 months after
the date of enactment of this Act, the Secretary shall submit to the
Congress a report that contains--
(1) a review of the models used by States to structure
their oversight of pharmacies that compound drug products,
including the structure of the agency or office responsible for
oversight and its relationship with the industry that it
regulates; and
(2) consideration of how the structure and relationship of
State regulators may impact the development and enforcement of
regulations to ensure safe compounded drug products.
(d) GAO Report.--The Comptroller General of the United States shall
review--
(1) the extent to which Federal health care programs (as
such term is defined in section 1128B(f) of the Social Security
Act (42 U.S.C. 1320a-7b)) ensure that compounded drug products
which are paid for by such programs are compounded in
facilities that comply with the requirements of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.);
(2) whether the reimbursement rates for compounded drug
products under such Federal health care programs are
appropriate, taking into consideration the cost of production
of such compounded drug products; and
(3) whether such Federal health care programs encourage the
use of compounded drug products in place of otherwise available
lawfully marketed drug products.
SEC. 4. PROHIBITIONS AND PENALTIES.
(a) Prohibition of Violations of Section 503A.--Section 301(d) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(d)) is amended
by inserting ``503A,'' before ``505,''.
(b) Penalties.--Section 303(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 333(b)) is amended by adding at the end the
following:
``(8) Notwithstanding subsection (a), any person who
violates section 301(d) with respect to any compounded drug
product--
``(A) knowingly and intentionally to defraud or
mislead; or
``(B) with conscious or reckless disregard of a
risk of death or serious bodily injury,
shall be fined under title 18, United States Code, imprisoned
for not more than 10 years, or both.''.
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