Preserving Patient Access to Compounded Medications Act of 2017
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the circumstances under which a drug may be compounded (manufactured at small scale) to allow pharmacists and physicians to compound drugs for administration to patients in an office or clinical setting, in accordance with state law. (Drugs that are compounded do not need to meet certain federal requirements regarding manufacturing, labeling, or approval.)
Dietary supplements may be used in the compounding of a drug.
The bill exempts from interstate distribution limits the dispensing of a compounded drug from the facility where it is compounded to a patient or health facility.
The scope of Food and Drug Administration (FDA) inspections of compounding pharmacies is limited to pertinent equipment, materials, containers, and labeling, which is the same scope as inspections of pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same scope as inspections of drug manufacturers.)
The bill eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.
[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2871 Introduced in House (IH)]
<DOC>
115th CONGRESS
1st Session
H. R. 2871
To amend the Federal Food, Drug, and Cosmetic Act with respect to
compounding pharmacies, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 12, 2017
Mr. Griffith (for himself and Mr. Cuellar) 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 with respect to
compounding pharmacies, and for other purposes.
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 ``Preserving Patient Access to
Compounded Medications Act of 2017''.
SEC. 2. OFFICE-USE COMPOUNDING WHEN AUTHORIZED BY STATE LAW.
Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353a(a)) is amended--
(1) in the matter preceding paragraph (1), by inserting
``or drug order for administration to a patient in an office or
clinical setting'' after ``is necessary for the identified
patient'';
(2) in paragraph (1), by striking ``or'' at the end;
(3) in paragraph (2), by striking the period at the end and
inserting ``; or''; and
(4) by adding at the end the following new paragraph:
``(3) is by a licensed pharmacist or licensed physician
pursuant to a valid prescription order or drug order and the
compounded drug is distributed or dispensed to a licensed
prescriber in accordance with State law, for administration to
a patient in an office or clinical setting.''.
SEC. 3. UNITED STATES PHARMACOPOEIA OR NATIONAL FORMULARY MONOGRAPH
REQUIREMENT.
Section 503A(b)(1)(A) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353A(b)(1)(A)) is amended--
(1) in the matter preceding subclause (i), by inserting ``,
or dietary supplements'' after ``Regulations''; and
(2) in clause (i)--
(A) by amending subclause (I) to read as follows:
``(I) comply with the monograph
standards in any section of the of the
United States Pharmacopoeia or National
Formulary, including drug substance or
dietary supplement monograph, if a
monograph exists.''; and
(B) by amending subclause (III) to read as follows:
``(III) if such monograph does not
exist and the drug substance or dietary
supplement is not a component of a drug
approved by the Secretary, but appears
on a list developed by the Secretary
through regulations issued by the
Secretary under subsection (c) of this
section;''.
SEC. 4. DEFINITIONS.
Subsection (e) of section 503A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353a) is amended to read as follows:
``(e) Definitions.--In this section:
``(1) Compounding.--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.
``(2) Distribute or distribution.--The terms `distribute'
or `distribution' do not include the act of dispensing of a
compounded drug product in accordance with this section.
``(3) Dispense.--The term `dispense' means for a drug
product compounded in accordance with this section, the act of
the drug product leaving the facility in which it was
compounded for delivery to a patient, patient's agent, or
health care facility (including a hospital, physician's office,
or other health care setting) pursuant to a valid prescription
order for an identified patient.''.
SEC. 5. APPLICABILITY OF RECORDS EXEMPTION FOR COMPOUNDING PHARMACIES.
(a) In General.--Section 704(a)(2)(A) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(a)(2)(A)) is amended to read as
follows:
``(A) pharmacies which maintain establishments in
conformance with any applicable local laws regulating
the practice of pharmacy and medicine and, for
compounding pharmacies, the provisions of section 503A,
and which are regularly engaged in dispensing or
distributing prescription drugs or devices, upon
prescriptions or drug orders of practitioners licensed
to administer such drugs or devices to patients under
the care of such practitioners in the course of their
professional practice, and which do not, either through
a subsidiary or otherwise, manufacture, prepare,
propagate, compound, or process drugs or devices for
sale other than in the regular course of their
business;''.
(b) Registration Exemption.--Section 510(g)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(g)(1)) is amended to read as
follows:
``(1) pharmacies which maintain establishments in
conformance with any applicable local laws regulating the
practice of pharmacy and medicine and, for compounding
pharmacies, the provisions of section 503A, and which are
regularly engaged in dispensing or distributing prescription
drugs or devices, upon prescriptions or drug orders of
practitioners licensed to administer such drugs or devices to
patients under the care of such practitioners in the course of
their professional practice, and which do not manufacture,
prepare, propagate, compound, or process drugs or devices for
sale other than in the regular course of their business;''.
SEC. 6. REGULATIONS.
(a) Rules Implementing New Requirements.--Not later than 90 days
after the date of enactment of this Act, the Secretary of Health and
Human Services shall promulgate rules on the record to carry out the
amendments made by this Act, in accordance with chapter 5 of title 5,
United States Code.
(b) Other Rules.--The Secretary of Health and Human Services shall
promulgate rules on the record to carry out any of the provisions of
section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
353a) other than those amended by this Act, in accordance with chapter
5 of title 5, United States Code.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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