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; 
‘‘(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 
compounding pharmacy. 
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‘‘(C) PROHIBITION
ON
DUAL
REGISTRA-
TION.—An entity registered under this sub-
section shall not be required to submit a reg-
istration under section 510. 
‘‘(D) 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 
compounding of drug products for use in a 
single State.’’; and 
(3) by adding at the end of section 503A 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— 
‘‘(A) the minimum standards for a 
compounding pharmacy license in each State; 
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‘‘(B) relevant information provided to the 
Secretary by State agencies that regulate phar-
macies; 
‘‘(C) reliable, timely, and comprehensive 
data related to inspections of such pharmacies, 
including the classification of actions indicated 
as a result of such inspections; and 
‘‘(D) other information determined rel-
evant 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; 
‘‘(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; and 
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‘‘(D) shall be accessible, as determined ap-
propriate by the Secretary, to health care pro-
viders and consumers. 
‘‘(h) ACTIVE INGREDIENTS
AND DOSAGE FORMS 
THAT SHOULD NOT BE COMPOUNDED.—The Secretary 
shall, after consultation with appropriate stakeholders (in-
cluding pharmacists, patient and public health advocacy 
groups, manufacturers, and health care professionals), 
promulgate a list of active ingredients and dosage forms 
that should not be compounded, because the compounding 
of such active ingredient or dosage form is reasonably like-
ly to present a risk to public health. 
‘‘(i) MINIMUM STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall pro-
mulgate minimum standards for the safe production 
of compounded drug products under this section. 
‘‘(2) CONTENTS.—The standards under para-
graph (1) shall each specify— 
‘‘(A) the type of compounded drug prod-
ucts to which they apply; and 
‘‘(B) the intended route of administration. 
‘‘(j) TRAINING.—The Secretary shall conduct a series 
of regional training opportunities for State agencies that 
regulate pharmacies that compound drug products. These 
training opportunities shall include information on the 
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minimum standards under subsection (i), sample inspec-
tion protocol, and recordkeeping to facilitate the inclusion 
of State findings and inspections into the database under 
subsection (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 
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). 
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(B) MEMBERSHIP.—The advisory com-
mittee shall include representatives of patients 
or 
consumers, 
health 
care 
providers, 
compounding pharmacies, State agencies that 
regulate compounding pharmacies, and at least 
one member with expertise on clearly commu-
nicating information in such labeling of drugs. 
(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). 
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(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-
opment of the regulations under paragraph 
(1)(B). 
(B) MEMBERSHIP.—The advisory com-
mittee shall include representatives of patients 
or 
consumers, 
health 
care 
providers, 
compounding pharmacies, State agencies that 
regulate compounding pharmacies, and informa-
tion technology 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). 
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(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-
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— 
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(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— 
(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 
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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 
(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— 
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‘‘(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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