II 

114TH CONGRESS 

1ST SESSION S. 1406 

To amend the Federal Food, Drug, and Cosmetic Act with respect to 

pharmacy compounding. 

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 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Saving Access to Com5 pounded Medications for Special Needs Patients Act’’. 

6 SEC. 2. PHARMACY COMPOUNDING. 

7 Section 503A of the Federal Food, Drug, and Cos8 metic Act (21 U.S.C. 353a) is amended— 

9 (1) by redesignating subsections (b) through (e) 

10 as subsections (c) through (f), respectively; 


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1 (2) by inserting after subsection (a) the fol2 lowing: 

3 ‘‘(b) DRUG PRODUCTS FOR DISTRIBUTION TO PRAC4 TITIONERS.—Sections 501(a)(2)(B), 502(f)(1), and 505 

5 shall not apply to a drug product if the drug product is 

6 compounded and distributed to a practitioner where, as 

7 permitted under State law, the drug product is used in 

8 the treatment of or administered to a patient of the practi9 tioner, and if the compounding is by— 

10 ‘‘(1) a licensed pharmacist in a State licensed 

11 pharmacy or a Federal facility; or 

12 ‘‘(2) a licensed physician.’’; 

13 (3) in subsection (c), as so redesignated— 

14 (A) in paragraph (1)— 

15 (i) in the matter preceding subpara16 graph (A), by striking ‘‘subsection (a)’’ 

17 and inserting ‘‘subsection (a) or (b)’’; 

18 (ii) in subparagraph (A)(i)(III), by 

19 striking ‘‘subsection (c)’’ and inserting 

20 ‘‘subsection (d)’’; 

21 (iii) in subparagraph (C), by striking 

22 ‘‘; and’’ and inserting ‘‘;’’; 

23 (iv) in subparagraph (D), by striking 

24 the period and inserting ‘‘; and’’; and 

25 (v) by adding at the end the following: 


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1 ‘‘(E) complies with standards contained 

2 within the United States Pharmacopeial Con3 vention General Chapters pertaining to the 

4 compounding of drug products.’’; 

5 (B) in paragraph (2), by striking ‘‘identi6 fied individual patient, which produces for that 

7 patient’’ and inserting ‘‘identified individual pa8 tient for whom the drug product is compounded 

9 under subsection (a) or patients of a practi10 tioner to whom the drug product is compounded 

11 and dispensed under subsection (b), which pro12 duces for that patient or patients’’; 

13 (C) in paragraph (3)— 

14 (i) in the matter preceding subpara15 graph (A), by striking ‘‘subsection (a)’’ 

16 and inserting ‘‘subsection (a) or (b)’’; 

17 (ii) in subparagraph (B)— 

18 (I) by amending clause (i) to 

19 read as follows: 

20 ‘‘(i) that has entered into a memo21 randum of understanding with the Sec22 retary that provides for appropriate inves23 tigation by a State agency of complaints 

24 relating to compounded drug products dis25 tributed outside such State; or’’; and 


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1 (II) by amending clause (ii) to 

2 read as follows: 

3 ‘‘(ii) that has not entered into a 

4 memorandum of understanding described 

5 in clause (i) and the licensed pharmacist, 

6 licensed pharmacy, or licensed physician 

7 distributes (or causes to be distributed) 

8 compounded drug products out of the 

9 State in which such products are com10 pounded in quantities that do not exceed 5 

11 percent of the total prescription orders dis12 pensed or distributed by such pharmacy or 

13 physician.’’; and 

14 (iii) in the flush text, by striking ‘‘Na15 tional Association of Boards of Pharmacy’’ 

16 and inserting ‘‘States’’; and 

17 (D) by adding at the end the following: 

18 ‘‘(4) LIMITATION ON MEMORANDUM OF UNDER19 STANDING.—A memorandum of understanding en20 tered into under paragraph (3)(B)(i) shall not create 

21 an unfunded mandate on a State.’’; 

22 (4) in subsection (d), as so redesignated— 

23 (A) in paragraph (1), by striking ‘‘sub24 sections (b)(1)(A)(i)(III), (b)(1)(C), or 


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1 (b)(3)(A)’’ and inserting ‘‘subsections 

2 (c)(1)(A)(i)(III), (c)(1)(C), or (c)(3)(A)’’; and 

3 (B) in paragraph (2), by striking ‘‘sub4 section (b)(1)(A)(i)(III)’’ and inserting ‘‘sub5 section (c)(1)(A)(i)(III)’’; and 

6 (5) by amending subsection (f), as so redesig7 nated to read as follows: 

8 ‘‘(f) DEFINITIONS.— 

9 ‘‘(1) COMPOUNDING.—As used in this section, 

10 the term ‘compounding’ does not include mixing, re11 constituting, or other such acts that are performed 

12 in accordance with directions contained in approved 

13 labeling provided by the product’s manufacturer and 

14 other manufacturer directions consistent with that 

15 labeling. 

16 ‘‘(2) DISTRIBUTE.—For purposes of this sec17 tion, the term ‘distribute’ does not include the dis18 pensing of a compounded drug product for an identi19 fied individual patient.’’. 

Æ 


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