Title: Preserving Patient Access to Compounded Medications Act of 2019
Policy area: Health

Summary:
Preserving Patient Access to Compounded Medications Act of 2019
This bill addresses regulations governing compounding pharmacies.
The bill expands the circumstances under which a drug may be compounded (i.e., 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. (Compounded drugs are not required 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 bill limits the scope of Food and Drug Administration (FDA) inspections of compounding pharmacies to certain equipment, materials, containers, and labeling. This aligns the scope of inspections of compounding pharmacies with the scope of inspections of other pharmacies. (Currently, the scope of inspections of compounding pharmacies is the same as the scope of inspections of drug manufacturers.)

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1959 Introduced in House (IH)]

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116th CONGRESS
  1st Session
                                H. R. 1959

   To amend the Federal Food, Drug, and Cosmetic Act with respect to 
            compounding pharmacies, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 28, 2019

  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 2019''.

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 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.
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