Saving Access to Compounded Medications for Special Needs Patients Act

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 (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) subsection (a) or (b) (ii) in subparagraph (A)(i)(III), by striking subsection (c) subsection (d) (iii) in subparagraph (C), by striking ; and ; (iv) in subparagraph (D), by striking the period and inserting ; 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 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) 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 States (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) subsections (c)(1)(A)(i)(III), (c)(1)(C), or (c)(3)(A) (B) in paragraph (2), by striking subsection (b)(1)(A)(i)(III) subsection (c)(1)(A)(i)(III) (5) by amending subsection (f), as so redesignated to read as follows: (f) Definitions (1) Compounding As used in this section, the term compounding (2) Distribute For purposes of this section, the term distribute .

Summary: Saving Access to Compounded Medications for Special Needs Patients Act This bill amends the Federal Food, Drug, and Cosmetic Act to allow drugs to be compounded (manufactured at a small scale) and distributed to practitioners for treatment of, or administration to, patients of that practitioner. Currently, drugs may be compounded only for identified individual patients. (Compounded drugs do not need to meet certain requirements for drugs regarding manufacturing, labeling, or FDA approval.) Compounded drugs must comply with United States Pharmacopeia standards. A memorandum of understanding (MOU) between the FDA and a state regarding compounded drugs no longer must address interstate distribution of inordinate amounts of compounded drugs. Such an MOU must not create an unfunded mandate on a state. (Compounders in states that do not have an MOU with the FDA may not distribute more than 5% of their orders out of state.)