I 
112TH CONGRESS 
2D SESSION 
H. R. 6638 
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 
DECEMBER 5, 2012 
Ms. DELAURO (for herself and Mrs. LOWEY) introduced the following bill; 
which was referred to the Committee 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 
2012’’ or the ‘‘S.A.F.E. Compounded Drugs Act of 2012’’. 
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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)(D), by striking ‘‘reg-
ularly or in inordinate amounts (as defined by 
the Secretary)’’; and 
(B) by adding at the end 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-
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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— 
‘‘(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— 
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‘‘(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 
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 
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‘‘(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 
a process for pharmacies described in sub-
section (a)(1)(A) to register as a compounding 
pharmacy. Such registration shall be conducted 
through an electronic method. 
‘‘(B) REGISTRATION REQUIREMENT.—Ex-
cept as provided in subparagraph (C), in order 
to be registered with the Secretary for purposes 
of subsection (a)(1)(A), every person who owns 
or operates a pharmacy shall submit to the Sec-
retary, in such time and manner as the Sec-
retary may require— 
‘‘(i) contact information for the phar-
macy; 
‘‘(ii) the State or States that the 
pharmacy is licensed in; 
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‘‘(iii) the methods used by the facility 
in compounding; and 
‘‘(iv) any additional information re-
quired by the Secretary, which may include 
the quantity of product compounded at 
such pharmacy for the purpose of deter-
mining if a drug manufacturing facility is 
inappropriately registering as a compound-
ing pharmacy. 
‘‘(C) EXCEPTION.—A pharmacy shall be 
exempt from the requirement to register under 
subsection (a)(1)(A) if the pharmacy— 
‘‘(i) employs fewer than 20 full-time 
employees (or 20 full-time equivalents); 
and 
‘‘(ii) performs traditional compound-
ing of drug products for use in a single 
State.’’; and 
(3) by adding at the end the following: 
‘‘(g) DATABASE.— 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish and maintain a database of information on 
pharmacies compounding drug products under sub-
section (a) that are licensed in more than one State, 
including— 
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‘‘(A) the minimum standards for a 
compounding pharmacy license in each State; 
‘‘(B) relevant information provided to the 
Secretary by State agencies that regulate phar-
macies; and 
‘‘(C) other information determined relevant 
by the Secretary. 
‘‘(2) DESIGN.—The database under paragraph 
(1)— 
‘‘(A) shall be accessible, as determined ap-
propriate by the Secretary, to State agencies 
that regulate pharmacies that compound drug 
products; 
‘‘(B) shall enable States and the Secretary 
to share information to ensure appropriate 
oversight of pharmacies that compound drug 
products; and 
‘‘(C) shall be used by the Secretary to in-
form the Federal inspection and oversight of 
pharmacies that compound drug products to en-
sure that issues and pharmacies identified in 
the database receive appropriate oversight. 
‘‘(h) MINIMUM STANDARDS.— 
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‘‘(1) The Secretary shall establish minimum 
standards for the safe production of compounded 
drug products. 
‘‘(2) The Secretary shall determine these min-
imum standards and shall determine the drug prod-
ucts that must meet the minimum standards. 
‘‘(3) The standards may include but is not lim-
ited to the intended route of administration and if 
the drug is sterile or non-sterile. If appropriate, the 
Secretary may consider the different types of drug 
products and set appropriate minimum standards 
for specific drug types or drug uses. 
‘‘(i) TRAINING.—The Secretary shall conduct a series 
of regional training opportunities for State agencies that 
regulate pharmacies that compound drug products. These 
training opportunities should include information on the 
minimum standards discussed in (h), sample inspection 
protocol, and recordkeeping to facilitate the inclusion of 
State findings and inspections into the database discussed 
in (g).’’. 
(b) DEADLINES AND ADVISORY COMMITTEES.— 
(1) DEADLINE
FOR
ISSUANCE
OF
REGULA-
TIONS.—Not later than 18 months after the date of 
enactment of this Act, the Secretary of Health and 
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Human Services shall issue regulations to imple-
ment— 
(A) paragraphs (4) and (5) of section 
503A(b) of the Federal Food, Drug, and Cos-
metic Act, as added by subsection (a); and 
(B) subsection (g) of section 503A of such 
Act. 
(2) LABELING ADVISORY COMMITTEE.— 
(A) ESTABLISHMENT.—The Secretary of 
Health and Human Services shall establish an 
advisory committee on labeling (as defined in 
section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) of compounded 
drug products and shall consult such committee 
in the development of the regulations under 
paragraph (1)(A). 
(B) MEMBERSHIP.—The advisory com-
mittee shall include representatives of patients 
or consumers, health care providers, compound-
ing pharmacies, State agencies that regulate 
compounding pharmacies, and at least one 
member with expertise on clearly commu-
nicating information in such labeling of drugs. 
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(C) MEETINGS.—The advisory committee 
shall hold an initial meeting not later than 6 
months after the date of enactment of this Act. 
(D) RECOMMENDATIONS.—Not later than 
12 months after the date of enactment of this 
Act, the advisory committee shall submit to the 
Secretary of Health and Human Services rec-
ommendations on the regulations under para-
graph (1)(A), including recommendations on 
the type of information and language that 
should be included on the labels of drug prod-
ucts that are compounded pursuant to section 
503A of the Federal Food, Drug, and Cosmetic 
Act. 
(E) TERMINATION.—The advisory com-
mittee under this subparagraph shall terminate 
upon the submission of the recommendations 
under subparagraph (D). 
(3) DATABASE ADVISORY COMMITTEE.— 
(A) ESTABLISHMENT.—The Secretary of 
Health and Human Services shall establish an 
advisory committee on the database described 
in section 503A(g) of the Federal Food, Drug, 
and Cosmetic Act, as added by subsection (a), 
and shall consult such committee in the devel-
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opment of the regulations under paragraph 
(1)(B). 
(B) MEMBERSHIP.—The advisory com-
mittee shall include representatives of patients 
or consumers, health care providers, compound-
ing pharmacies, State agencies that regulate 
compounding pharmacies, and information tech-
nology experts. 
(C) MEETINGS.—The advisory committee 
shall hold an initial meeting not later than 6 
months after the date of enactment of this Act. 
(D) RECOMMENDATIONS.—Not later than 
12 months after the date of enactment of this 
Act, the advisory committee shall submit to the 
Secretary of Health and Human Services rec-
ommendations on the regulations under para-
graph (1)(B). 
(E) TERMINATION.—The advisory com-
mittee under this subparagraph shall terminate 
upon the submission of the recommendations 
under subparagraph (D). 
(4) PERMANENT
ADVISORY
COMMITTEE
ON 
PHARMACY
COMPOUNDING.—The Secretary shall 
convene the Advisory Committee on Pharmacy 
Compounding as appropriate to consider issues re-
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lated to the safety and availability of compounded 
drug products. 
SEC. 3. REPORTS AND STUDIES. 
(a) BIANNUAL REPORTS.—Not later than 6 months 
after the date of enactment of this Act, and at the end 
of each succeeding 6-month period that ends before the 
25th month after the date of enactment of this Act, the 
Secretary of Health and Human Services shall submit to 
the Congress a report on the status of the implementation 
of the requirements of this Act, and the amendments made 
by this Act. 
(b) THIRD-PARTY ACCREDITATION.—Not later than 
12 months after the date of enactment of this Act, the 
Secretary shall submit to the Congress a report that con-
tains— 
(1) a review of the standards used by organiza-
tions that provide accreditation to compounding 
pharmacies; and 
(2) an evaluation of the effectiveness of such 
standards in ensuring the production of safe and ef-
fective compounded drug products. 
(c) STRUCTURE OF STATE OVERSIGHT.—Not later 
than 18 months after the date of enactment of this Act, 
the Secretary shall submit to the Congress a report that 
contains— 
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(1) a review of the models used by States to 
structure their oversight of pharmacies that com-
pound drug products, including the structure of the 
agency or office responsible for oversight and its re-
lationship with the industry that it regulates; and 
(2) consideration of how the structure and rela-
tionship of State regulators may impact the develop-
ment and enforcement of regulations to ensure safe 
compounded drug products. 
(d) GAO REPORT.—The Comptroller General of the 
United States shall review— 
(1) the extent to which Federal health care pro-
grams (as such term is defined in section 1128B(f) 
of the Social Security Act (42 U.S.C. 1320a–7b)) 
ensure that compounded drug products which are 
paid for by such programs are compounded in facili-
ties that comply with the requirements of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 
et seq.); 
(2) whether the reimbursement rates for com-
pounded drug products under such Federal health 
care programs are appropriate, taking into consider-
ation the cost of production of such compounded 
drug products; and 
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(3) whether such Federal health care programs 
encourage the use of compounded drug products in 
place of otherwise available lawfully marketed drug 
products. 
SEC. 4. PROHIBITIONS AND PENALTIES. 
(a) PROHIBITION
OF
VIOLATIONS
OF
SECTION 
503A.—Section 301(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(d)) is amended by inserting 
‘‘503A,’’ before ‘‘505,’’. 
(b) PENALTIES.—Section 303(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(b)) is 
amended by adding at the end the following: 
‘‘(8) Notwithstanding subsection (a), any per-
son who violates section 301(d) with respect to any 
compounded drug product— 
‘‘(A) knowingly and intentionally to de-
fraud or mislead; or 
‘‘(B) with conscious or reckless disregard 
of a risk of death or serious bodily injury, 
shall be fined under title 18, United States Code, 
imprisoned for not more than 10 years, or both.’’. 
Æ 
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