I 

116TH CONGRESS 

1ST SESSION H. R. 1959 

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

compounding pharmacies, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 28, 2019 

Mr. GRIFFITH (for himself and Mr. CUELLAR) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

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

respect to compounding pharmacies, and for other purposes. 

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 ‘‘Preserving Patient Ac5 cess to Compounded Medications Act of 2019’’. 

6 SEC. 2. OFFICE-USE COMPOUNDING WHEN AUTHORIZED BY 

7 STATE LAW. 

8 Section 503A(a) of the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 353a(a)) is amended— 


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1 (1) in the matter preceding paragraph (1), by 

2 inserting ‘‘or drug order for administration to a pa3 tient in an office or clinical setting’’ after ‘‘is nec4 essary for the identified patient’’; 

5 (2) in paragraph (1), by striking ‘‘or’’ at the 

6 end; 

7 (3) in paragraph (2), by striking the period at 

8 the end and inserting ‘‘; or’’; and 

9 (4) by adding at the end the following new 

10 paragraph: 

11 ‘‘(3) is by a licensed pharmacist or licensed 

12 physician pursuant to a valid prescription order or 

13 drug order and the compounded drug is distributed 

14 or dispensed to a licensed prescriber in accordance 

15 with State law, for administration to a patient in an 

16 office or clinical setting.’’. 

17 SEC. 3. UNITED STATES PHARMACOPOEIA OR NATIONAL 

18 FORMULARY MONOGRAPH REQUIREMENT. 

19 Section 503A(b)(1)(A) of the Federal Food, Drug, 

20 and Cosmetic Act (21 U.S.C. 353A(b)(1)(A)) is amend21 ed— 

22 (1) in the matter preceding subclause (i), by in23 serting ‘‘, or dietary supplements’’ after ‘‘Regula24 tions’’; and 

25 (2) in clause (i)— 


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1 (A) by amending subclause (I) to read as 

2 follows: 

3 ‘‘(I) comply with the monograph 

4 standards in any section of the United 

5 States Pharmacopoeia or National 

6 Formulary, including drug substance 

7 or dietary supplement monograph, if a 

8 monograph exists.’’; and 

9 (B) by amending subclause (III) to read as 

10 follows: 

11 ‘‘(III) if such monograph does 

12 not exist and the drug substance or 

13 dietary supplement is not a compo14 nent of a drug approved by the Sec15 retary, but appears on a list developed 

16 by the Secretary through regulations 

17 issued by the Secretary under sub18 section (c) of this section;’’. 

19 SEC. 4. DEFINITIONS. 

20 Subsection (e) of section 503A of the Federal Food, 

21 Drug, and Cosmetic Act (21 U.S.C. 353a) is amended to 

22 read as follows: 

23 ‘‘(e) DEFINITIONS.—In this section: 

24 ‘‘(1) COMPOUNDING.—The term ‘compounding’ 

25 does not include mixing, reconstituting, or other 


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1 such acts that are performed in accordance with di2 rections contained in approved labeling provided by 

3 the product’s manufacturer and other manufacturer 

4 directions consistent with that labeling. 

5 ‘‘(2) DISTRIBUTE OR DISTRIBUTION.—The 

6 terms ‘distribute’ or ‘distribution’ do not include the 

7 act of dispensing of a compounded drug product in 

8 accordance with this section. 

9 ‘‘(3) DISPENSE.—The term ‘dispense’ means 

10 for a drug product compounded in accordance with 

11 this section, the act of the drug product leaving the 

12 facility in which it was compounded for delivery to 

13 a patient, patient’s agent, or health care facility (in14 cluding a hospital, physician’s office, or other health 

15 care setting) pursuant to a valid prescription order 

16 for an identified patient.’’. 

17 SEC. 5. APPLICABILITY OF RECORDS EXEMPTION FOR 

18 COMPOUNDING PHARMACIES. 

19 (a) IN GENERAL.—Section 704(a)(2)(A) of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 374(a)(2)(A)) is amended to read as follows: 

22 ‘‘(A) pharmacies which maintain establish23 ments in conformance with any applicable local 

24 laws regulating the practice of pharmacy and 

25 medicine and, for compounding pharmacies, the 


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1 provisions of section 503A, and which are regu2 larly engaged in dispensing or distributing pre3 scription drugs or devices, upon prescriptions or 

4 drug orders of practitioners licensed to admin5 ister such drugs or devices to patients under 

6 the care of such practitioners in the course of 

7 their professional practice, and which do not, ei8 ther through a subsidiary or otherwise, manu9 facture, prepare, propagate, compound, or proc10 ess drugs or devices for sale other than in the 

11 regular course of their business;’’. 

12 (b) REGISTRATION EXEMPTION.—Section 510(g)(1) 

13 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

14 360(g)(1)) is amended to read as follows: 

15 ‘‘(1) pharmacies which maintain establishments 

16 in conformance with any applicable local laws regu17 lating the practice of pharmacy and medicine and, 

18 for compounding pharmacies, the provisions of sec19 tion 503A, and which are regularly engaged in dis20 pensing or distributing prescription drugs or devices, 

21 upon prescriptions or drug orders of practitioners li22 censed to administer such drugs or devices to pa23 tients under the care of such practitioners in the 

24 course of their professional practice, and which do 

25 not manufacture, prepare, propagate, compound, or 


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1 process drugs or devices for sale other than in the 

2 regular course of their business;’’. 

3 SEC. 6. REGULATIONS. 

4 (a) RULES IMPLEMENTING NEW REQUIREMENTS.— 

5 Not later than 90 days after the date of enactment of this 

6 Act, the Secretary of Health and Human Services shall 

7 promulgate rules on the record to carry out the amend8 ments made by this Act, in accordance with chapter 5 of 

9 title 5, United States Code. 

10 (b) OTHER RULES.—The Secretary of Health and 

11 Human Services shall promulgate rules on the record to 

12 carry out any of the provisions of section 503A of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 353a) 

14 other than those amended by this Act, in accordance with 

15 chapter 5 of title 5, United States Code. 

Æ 


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