S. 1406 — Introduced in Senate

II 114th CONGRESS 1st Session S. 1406 IN THE SENATE OF THE UNITED STATES May 20, 2015 Mr. Vitter introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to pharmacy compounding. 1. Short title This Act may be cited as the Saving Access to Compounded Medications for Special Needs Patients Act. 2. Pharmacy compounding Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is amended— (1) by redesignating subsections (b) through (e) as subsections (c) through (f), respectively; (2) by inserting after subsection (a) the following: (b) Drug products for distribution to practitioners Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded and distributed to a practitioner where, as permitted under State law, the drug product is used in the treatment of or administered to a patient of the practitioner, and if the compounding is by— (1) a licensed pharmacist in a State licensed pharmacy or a Federal facility; or (2) a licensed physician. ; (3) in subsection (c), as so redesignated— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by striking subsection (a) and inserting subsection (a) or (b); (ii) in subparagraph (A)(i)(III), by striking subsection (c) and inserting subsection (d); (iii) in subparagraph (C), by striking ; and and inserting ;; (iv) in subparagraph (D), by striking the period and inserting ; and; and (v) by adding at the end the following: (E) complies with standards contained within the United States Pharmacopeial Convention General Chapters pertaining to the compounding of drug products. ; (B) in paragraph (2), by striking identified individual patient, which produces for that patient and inserting identified individual patient for whom the drug product is compounded under subsection (a) or patients of a practitioner to whom the drug product is compounded and dispensed under subsection (b), which produces for that patient or patients; (C) in paragraph (3)— (i) in the matter preceding subparagraph (A), by striking subsection (a) and inserting subsection (a) or (b); (ii) in subparagraph (B)— (I) by amending clause (i) to read as follows: (i) that has entered into a memorandum of understanding with the Secretary that provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or ; and (II) by amending clause (ii) to read as follows: (ii) that has not entered into a memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which such products are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician. ; and (iii) in the flush text, by striking National Association of Boards of Pharmacy and inserting States; and (D) by adding at the end the following: (4) Limitation on memorandum of understanding A memorandum of understanding entered into under paragraph (3)(B)(i) shall not create an unfunded mandate on a State. ; (4) in subsection (d), as so redesignated— (A) in paragraph (1), by striking subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A) and inserting subsections (c)(1)(A)(i)(III), (c)(1)(C), or (c)(3)(A); and (B) in paragraph (2), by striking subsection (b)(1)(A)(i)(III) and inserting subsection (c)(1)(A)(i)(III); and (5) by amending subsection (f), as so redesignated to read as follows: (f) Definitions (1) Compounding As used in this section, 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 For purposes of this section, the term distribute does not include the dispensing of a compounded drug product for an identified individual patient. .