Saving Access to Compounded Medications for Special Needs Patients Act

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.)

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Saving Access to Compounded 
Medications for Special Needs Patients Act''.

SEC. 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.''.