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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Preserving Patient Ac-
cess to Compounded Medications Act of 2019’’. 
SEC. 2. OFFICE-USE COMPOUNDING WHEN AUTHORIZED BY 
STATE LAW. 
Section 503A(a) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 353a(a)) is amended— 
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(1) in the matter preceding paragraph (1), by 
inserting ‘‘or drug order for administration to a pa-
tient in an office or clinical setting’’ after ‘‘is nec-
essary for the identified patient’’; 
(2) in paragraph (1), by striking ‘‘or’’ at the 
end; 
(3) in paragraph (2), by striking the period at 
the end and inserting ‘‘; or’’; and 
(4) by adding at the end the following new 
paragraph: 
‘‘(3) is by a licensed pharmacist or licensed 
physician pursuant to a valid prescription order or 
drug order and the compounded drug is distributed 
or dispensed to a licensed prescriber in accordance 
with State law, for administration to a patient in an 
office or clinical setting.’’. 
SEC. 3. UNITED STATES PHARMACOPOEIA OR NATIONAL 
FORMULARY MONOGRAPH REQUIREMENT. 
Section 503A(b)(1)(A) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 353A(b)(1)(A)) is amend-
ed— 
(1) in the matter preceding subclause (i), by in-
serting ‘‘, or dietary supplements’’ after ‘‘Regula-
tions’’; and 
(2) in clause (i)— 
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(A) by amending subclause (I) to read as 
follows: 
‘‘(I) comply with the monograph 
standards in any section of the United 
States Pharmacopoeia or National 
Formulary, including drug substance 
or dietary supplement monograph, if a 
monograph exists.’’; and 
(B) by amending subclause (III) to read as 
follows: 
‘‘(III) if such monograph does 
not exist and the drug substance or 
dietary supplement is not a compo-
nent of a drug approved by the Sec-
retary, but appears on a list developed 
by the Secretary through regulations 
issued by the Secretary under sub-
section (c) of this section;’’. 
SEC. 4. DEFINITIONS. 
Subsection (e) of section 503A of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353a) is amended to 
read as follows: 
‘‘(e) DEFINITIONS.—In this section: 
‘‘(1) COMPOUNDING.—The term ‘compounding’ 
does not include mixing, reconstituting, or other 
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such acts that are performed in accordance with di-
rections contained in approved labeling provided by 
the product’s manufacturer and other manufacturer 
directions consistent with that labeling. 
‘‘(2) 
DISTRIBUTE
OR
DISTRIBUTION.—The 
terms ‘distribute’ or ‘distribution’ do not include the 
act of dispensing of a compounded drug product in 
accordance with this section. 
‘‘(3) DISPENSE.—The term ‘dispense’ means 
for a drug product compounded in accordance with 
this section, the act of the drug product leaving the 
facility in which it was compounded for delivery to 
a patient, patient’s agent, or health care facility (in-
cluding a hospital, physician’s office, or other health 
care setting) pursuant to a valid prescription order 
for an identified patient.’’. 
SEC. 5. APPLICABILITY OF RECORDS EXEMPTION FOR 
COMPOUNDING PHARMACIES. 
(a) IN GENERAL.—Section 704(a)(2)(A) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
374(a)(2)(A)) is amended to read as follows: 
‘‘(A) pharmacies which maintain establish-
ments in conformance with any applicable local 
laws regulating the practice of pharmacy and 
medicine and, for compounding pharmacies, the 
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provisions of section 503A, and which are regu-
larly engaged in dispensing or distributing pre-
scription drugs or devices, upon prescriptions or 
drug orders of practitioners licensed to admin-
ister such drugs or devices to patients under 
the care of such practitioners in the course of 
their professional practice, and which do not, ei-
ther through a subsidiary or otherwise, manu-
facture, prepare, propagate, compound, or proc-
ess drugs or devices for sale other than in the 
regular course of their business;’’. 
(b) REGISTRATION EXEMPTION.—Section 510(g)(1) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360(g)(1)) is amended to read as follows: 
‘‘(1) pharmacies which maintain establishments 
in conformance with any applicable local laws regu-
lating the practice of pharmacy and medicine and, 
for compounding pharmacies, the provisions of sec-
tion 503A, and which are regularly engaged in dis-
pensing or distributing prescription drugs or devices, 
upon prescriptions or drug orders of practitioners li-
censed to administer such drugs or devices to pa-
tients under the care of such practitioners in the 
course of their professional practice, and which do 
not manufacture, prepare, propagate, compound, or 
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process drugs or devices for sale other than in the 
regular course of their business;’’. 
SEC. 6. REGULATIONS. 
(a) RULES IMPLEMENTING NEW REQUIREMENTS.— 
Not later than 90 days after the date of enactment of this 
Act, the Secretary of Health and Human Services shall 
promulgate rules on the record to carry out the amend-
ments made by this Act, in accordance with chapter 5 of 
title 5, United States Code. 
(b) OTHER RULES.—The Secretary of Health and 
Human Services shall promulgate rules on the record to 
carry out any of the provisions of section 503A of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 353a) 
other than those amended by this Act, in accordance with 
chapter 5 of title 5, United States Code. 
Æ 
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