Preserving Patient Access to Compounded Medications Act of 2019

To amend the Federal Food, Drug, and Cosmetic Act with respect to compounding pharmacies, and for other purposes. 1. Short title This Act may be cited as the Preserving Patient Access to Compounded Medications Act of 2019 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) (1) in the matter preceding paragraph (1), by inserting or drug order for administration to a patient in an office or clinical setting is necessary for the identified patient (2) in paragraph (1), by striking or (3) in paragraph (2), by striking the period at the end and inserting ; or (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. . 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) (1) in the matter preceding subclause (i), by inserting , or dietary supplements Regulations (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; . 4. Definitions Subsection (e) of section 503A of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 353a (e) Definitions In this section: (1) Compounding The term compounding (2) Distribute or distribution The terms distribute distribution (3) Dispense The term dispense . 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) (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) (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; . 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 (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 chapter 5

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.) The bill also eliminates the requirement for compounding pharmacies to register with the FDA as drug manufacturers.