Title: Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
Policy area: Health

Summary:
Patient Access to Urgent-Use Pharmacy Compounding Act of 2021
This bill relaxes certain requirements for compounding drugs that are facing shortages.
Drug compounding is the process of mixing or otherwise altering drugs to create a medication. Currently, the Food and Drug Administration (FDA) allows for drug compounding subject to certain requirements. Generally a licensed pharmacist or physician not registered with the FDA may only compound drugs in limited quantities for prescriptions for a specific individual patient. On the other hand, an FDA-registered outsourcing facility may compound drugs in bulk for use in medical facilities but is subject to additional requirements.
This bill allows a compounder not registered with the FDA to compound drugs in limited quantities for urgent medical need not involving a specific patient if, among other things, (1) the prescriber certifies that they are unable to obtain, despite reasonable attempts, certain related drugs with the same active ingredient and route of administration; (2) the compounded drug meets certain labeling requirements, including an indication that the compounded drug is provided only for urgent administration to a patient; and (3) the compounder requests and maintains certain records about patients receiving the compounded drug.
Furthermore, a restriction against an unregistered compounder regularly compounding (or compounding inordinate amounts of) what is essentially a copy of a commercially available drug shall not apply if the drug is on a shortage list maintained by the FDA or the American Society of Hospital Pharmacists.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3662 Introduced in House (IH)]

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117th CONGRESS
  1st Session
                                H. R. 3662

 To amend the Federal Food, Drug, and Cosmetic Act to ensure patients 
have access to certain urgent-use compounded medications, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              June 1, 2021

  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 to ensure patients 
have access to certain urgent-use compounded medications, 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 ``Patient Access to Urgent-Use 
Pharmacy Compounding Act of 2021''.

SEC. 2. URGENT-USE COMPOUNDING FOR ADMINISTRATION IN HOSPITALS OR OTHER 
              CLINICAL SETTINGS.

    Section 503A(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353a(a)) is amended--
            (1) in paragraph (1), by striking ``or'' at the end;
            (2) in paragraph (2)(B)(ii)(II), by striking the period at 
        the end and inserting ``; or''; and
            (3) by adding at the end the following new paragraph:
            ``(3) notwithstanding the requirement in the matter 
        preceding paragraph (1) that the drug product is compounded for 
        an identified individual patient based on a valid prescription 
        order or notation described in such matter, is by a licensed 
        pharmacist or licensed physician and the compounded drug 
        product is compounded for distribution in limited quantities to 
        a licensed prescriber for urgent administration to a patient in 
        a hospital or other clinical setting, provided that all of the 
        following are met:
                    ``(A) The licensed prescriber certifies by notation 
                on the order to the compounding pharmacist or physician 
                that the licensed prescriber has made reasonable 
                attempts to obtain, and has not been able to obtain, to 
                address the urgent medical need--
                            ``(i) a drug product that is approved or 
                        authorized by the Food and Drug Administration 
                        with the same active ingredient and the same 
                        route of administration; or
                            ``(ii) a drug product that is compounded by 
                        an outsourcing facility in accordance with 
                        section 503B with the same active ingredient 
                        and the same route of administration.
                    ``(B) The compounded drug product is labeled with a 
                beyond-use-date in accordance with applicable United 
                States Pharmacopeia standards.
                    ``(C) The licensed pharmacist or licensed physician 
                marks the packaging of the compounded drug product with 
                text--
                            ``(i) indicating that the drug product is 
                        provided to the hospital or other clinical 
                        setting only for urgent administration to a 
                        patient; and
                            ``(ii) requesting that the hospital or 
                        other clinical setting provide to the 
                        compounding pharmacist or physician the records 
                        that identify the patient or patients to whom 
                        the drug products were administered within--
                                    ``(I) 7 days of each such patient 
                                receiving such medication; or
                                    ``(II) 7 days of each such patient 
                                being discharged.
                    ``(D) Upon receipt of records requested pursuant to 
                subparagraph (C)(ii), the licensed pharmacist or 
                licensed physician ensures that the patient information 
                in such records is linked with the respective order.
                    ``(E) The licensed pharmacist or licensed physician 
                reports adverse events associated with the compounded 
                drug product as soon as possible but no later than 15 
                days after becoming aware of such events to the 
                MedWatch Adverse Event Reporting program of the Food 
                and Drug Administration (or any successor program).''.

SEC. 3. COMPOUNDING FOR SHORTAGES FOR ADMINISTRATION IN HOSPITALS OR 
              OTHER CLINICAL SETTINGS.

    Paragraph (2) of section 503A(b) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 353a(b)(2)) is amended to read as follows:
            ``(2) Definition.--For purposes of paragraph (1)(D), the 
        term `essentially a copy of a commercially available drug 
        product' does not include--
                    ``(A) 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; or
                    ``(B) a drug product that meets each of the 
                following conditions:
                            ``(i) At the time of compounding, 
                        distribution, or dispensing, the drug product 
                        appears on--
                                    ``(I) the drug shortage list in 
                                effect under section 506E; or
                                    ``(II) the drug shortage list 
                                maintained by the American Society of 
                                Hospital Pharmacists.
                            ``(ii) If the drug product is not 
                        compounded for an identified individual patient 
                        based on a valid prescription order or 
                        notation, notwithstanding such requirement in 
                        the matter preceding paragraph (1) of 
                        subsection (a), then the drug product--
                                    ``(I) is labeled in accordance 
                                subparagraphs (B) and (C) of subsection 
                                (a)(3); and
                                    ``(II) is documented by the 
                                compounding pharmacist or physician in 
                                accordance with subparagraphs (D) and 
                                (E) of subsection (a)(3).''.
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