I 
113TH CONGRESS 
1ST SESSION H. R. 3019 
To amend chapter V of the Federal Food, Drug, and Cosmetic Act to 
enhance the requirements for pharmacies that compound drug products. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 2, 2013 
Ms. DELAURO (for herself, Mrs. LOWEY, Mr. CONYERS, Mr. HONDA, and Mr. 
ELLISON) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend chapter V of the Federal Food, Drug, and Cos-
metic Act to enhance the requirements for pharmacies 
that compound drug products. 
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 ‘‘Supporting Access to 
Formulated and Effective Compounded Drugs Act of 
2013’’ or the ‘‘S.A.F.E. Compounded Drugs Act of 2013’’. 
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SEC. 2. ENHANCED REQUIREMENTS FOR COMPOUNDED 
DRUGS. 
(a) IN GENERAL.—Section 503A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is 
amended— 
(1) in subsection (a)(1)(A), by inserting ‘‘that 
is registered with the Secretary under subsection 
(b)(6) (or is subject to the exception under sub-
section (b)(6)(C))’’ after ‘‘State licensed pharmacy’’; 
(2) in subsection (b)— 
(A) in paragraph (1)(A), by inserting 
‘‘(meaning not more than 5 percent of the total 
quantity of drugs products compounded by the 
pharmacist or physician in any 30 day period)’’ 
after ‘‘limited quantities’’; 
(B) in paragraph (1)(C), by striking ‘‘and’’ 
at the end; 
(C) in paragraph (1)(D), by striking ‘‘reg-
ularly or in inordinate amounts (as defined by 
the Secretary)’’; 
(D) by adding at the end of paragraph (1) 
the following: 
‘‘(E) does not compound a drug product 
that appears on the list promulgated by the 
Secretary under subsection (h); and 
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‘‘(F) does not compound a drug product in 
violation of the minimum standards promul-
gated under subsection (i).’’; and 
(E) by adding at the end of the subsection 
the following: 
‘‘(4) NOTIFICATION.— 
‘‘(A) PRESCRIBER NOTIFICATION.—Before 
providing a prescription order for a drug to be 
compounded under subsection (a), the physician 
or other licensed practitioner who will write 
such order shall— 
‘‘(i) inform the individual patient for 
whom such order is being written that a 
compounded drug is being prescribed; and 
‘‘(ii) provide such patient with a writ-
ten document containing information con-
cerning the availability, safety, and produc-
tion of compounded drugs. 
‘‘(B) CONFIRMATION
BY
PHARMACIST.— 
Except in the case of a compounded drug prod-
uct used in a procedure described in subpara-
graph (C), a licensed pharmacist or licensed 
physician who dispenses a compounded drug 
under subsection (a) shall, at the time such 
drug is dispensed— 
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‘‘(i) confirm that the patient (or the 
individual to whom the drug is delivered on 
behalf of the patient) understands that the 
drug is a compounded drug; and 
‘‘(ii) provide a written document con-
taining the information described in sub-
paragraph (A)(ii). 
‘‘(C) PROVIDER NOTIFICATION.—Prior to 
providing a health care service that will be con-
ducted by a health care provider in a health 
care setting (such as a hospital or a physician’s 
office) and during which service a drug com-
pounded under subsection (a) will be adminis-
tered to a patient for purposes of treating such 
patient, the health care provider shall— 
‘‘(i) inform the patient that a com-
pounded drug will be used during the pro-
cedure; and 
‘‘(ii) provide such patient with a writ-
ten document containing the information 
described in subparagraph (A)(ii). 
‘‘(5) LABELING.— 
‘‘(A) IN GENERAL.—A drug product com-
pounded under subsection (a) shall be clearly 
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labeled as a ‘non-FDA approved compounded 
drug product’. 
‘‘(B) 
DEVELOPMENT
OF
REQUIRE-
MENTS.—In determining the requirements for 
the label under subparagraph (A), the Sec-
retary— 
‘‘(i) shall establish, and consult with, 
a temporary advisory committee on com-
pounded drug product labeling require-
ments; and 
‘‘(ii) may establish different labeling 
requirements for— 
‘‘(I) a compounded drug product 
intended for use by a health care pro-
vider in an office or treatment setting; 
and 
‘‘(II) a compounded drug product 
intended for any use not described in 
subclause (I). 
‘‘(6) REGISTRATION.— 
‘‘(A) ESTABLISHMENT OF PROCESS.—The 
Secretary, in consultation with experts and rep-
resentatives of stakeholders including phar-
macies, compounding pharmacies, State regu-
lators, and health care providers, shall establish 
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