Patient Access to Urgent-Use Pharmacy Compounding Act of 2021

To amend the Federal Food, Drug, and Cosmetic Act to ensure patients have access to certain urgent-use compounded medications, and for other purposes. 1. Short title This Act may be cited as the Patient Access to Urgent-Use Pharmacy Compounding Act of 2021 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) (1) in paragraph (1), by striking or (2) in paragraph (2)(B)(ii)(II), by striking the period at the end and inserting ; or (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). . 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) (2) Definition For purposes of paragraph (1)(D), the term essentially a copy of a commercially available drug product (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). .

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.