I 
112TH CONGRESS 
2D SESSION 
H. R. 6584 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
compounding of drug products. 
IN THE HOUSE OF REPRESENTATIVES 
NOVEMBER 2, 2012 
Mr. MARKEY (for himself, Mr. COHEN, Ms. SLAUGHTER, Mr. LYNCH, and Mr. 
OLVER) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for the compounding of 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 ‘‘Verifying Authority 
and Legality In Drug Compounding Act of 2012’’. 
SEC. 2. APPLICATION OF FEDERAL LAW TO PRACTICE OF 
PHARMACY COMPOUNDING. 
(a) AMENDMENT.—Section 503A of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353a) is 
amended to read as follows: 
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‘‘SEC. 503A. PHARMACY COMPOUNDING. 
‘‘(a) IN GENERAL.—Sections 501(a)(2)(B) and 505 
shall not apply with respect to a drug product if each of 
the following applies: 
‘‘(1) The drug product is compounded for an 
identified individual patient based on the receipt 
of— 
‘‘(A) a valid prescription order; or 
‘‘(B) a notation, approved by the pre-
scribing practitioner, on the prescription order 
that a compounded product is necessary for the 
identified patient. 
‘‘(2) The drug product is compounded by a li-
censed pharmacist in a State-licensed pharmacy or a 
Federal facility, or by a licensed physician, pursuant 
to such prescription order or notation. 
‘‘(3) The drug product is compounded exclu-
sively from— 
‘‘(A) ingredients that comply with the 
standards of an applicable United States Phar-
macopoeia or National Formulary monograph; 
or 
‘‘(B) if such a monograph does not exist, 
ingredients that are ingredients in a drug— 
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‘‘(i) for which an approval of an appli-
cation filed under subsection (b) or (j) of 
section 505 is in effect; or 
‘‘(ii) that may be lawfully marketed in 
the United States without such an ap-
proval pursuant to the definition of a new 
drug in section 201. 
‘‘(4) Any bulk substance used for purposes of 
compounding the drug product— 
‘‘(A) is manufactured by an establishment 
that is registered under section 510 (including 
a foreign establishment that is registered under 
section 510(i)); and 
‘‘(B) is accompanied by valid certificates of 
analysis. 
‘‘(5) The pharmacist or physician compounding 
the drug product complies with the standards of any 
applicable United States Pharmacopoeia chapters on 
pharmacy compounding. 
‘‘(6) The drug product, including the dosage 
form and any ingredient thereof, is not included in 
the list under subsection (b). 
‘‘(7) The drug product is not a copy of a com-
mercially available drug. 
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‘‘(b) LIST OF DRUG PRODUCTS THAT SHOULD NOT 
BE COMPOUNDED.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(6), the Secretary shall— 
‘‘(A) develop and maintain a list of drug 
products that should not be compounded, in-
cluding any categories, dosage forms, or ingre-
dients of such drug products; and 
‘‘(B) include on such list, at a minimum— 
‘‘(i) drug products (or categories, dos-
age forms, or ingredients thereof) whose 
compounding is reasonably likely to cause 
an adverse effect on safety or effectiveness 
of such drug product; and 
‘‘(ii) drug products (or categories, 
dosage forms, or ingredients thereof) that 
have been withdrawn or removed from the 
market because they have been found to be 
unsafe or not effective. 
‘‘(2) INITIAL
PUBLICATION; UPDATES.—The 
Secretary shall— 
‘‘(A) not later than 1 year after the date 
of the enactment of the Verifying Authority and 
Legality In Drug Compounding Act of 2012, 
publish an initial list under paragraph (1); and 
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‘‘(B) not less frequently than every year 
thereafter, review and, as appropriate, update 
the list under paragraph (1). 
‘‘(3) AVAILABILITY.—The Secretary shall make 
the list under paragraph (1) available on the public 
Web site of the Food and Drug Administration. 
‘‘(4) TRANSMISSION
TO
STATE
REGULATORY 
AGENCIES.—Upon publication of the initial list 
under paragraph (1), and upon each update to the 
list, the Secretary shall transmit an up-to-date copy 
of the list to the agency in each State with primary 
responsibility for regulating the compounding of 
drugs. 
‘‘(c) WAIVER OF REQUIREMENT OF INDIVIDUALLY 
IDENTIFIED
PATIENT
FOR
SPECIFIED
DRUG
PROD-
UCTS.— 
‘‘(1) WAIVER AUTHORITY.—The Secretary may, 
with respect to a drug product sold or dispensed by 
a pharmacy or pharmacist, waive the requirement of 
subsection (a)(1) that the drug product be com-
pounded for an individually identified patient if the 
Secretary determines that compounding the drug 
product is necessary— 
‘‘(A) to address a drug shortage; or 
‘‘(B) to protect public health or well-being. 
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‘‘(2) DURATION.—The duration of a waiver 
under paragraph (1) shall not exceed 1 year, unless 
the Secretary determines that an extension is nec-
essary to continue— 
‘‘(A) to address the drug shortage for 
which such waiver was originally approved; or 
‘‘(B) to protect public health or well-being. 
‘‘(3) WAIVERS BY STATES PROHIBITED.—The 
Secretary may not authorize any State to grant 
waivers under this subsection. 
‘‘(d) WAIVER OF REQUIREMENT OF INDIVIDUALLY 
IDENTIFIED PATIENT FOR SPECIFIED PHARMACIES AND 
PHARMACISTS.— 
‘‘(1) WAIVER AUTHORITY.—The Secretary may 
waive the requirement of subsection (a)(1) that the 
drug product be compounded for an individually 
identified patient if the pharmacy or pharmacist— 
‘‘(A) submits an application that meets the 
requirements of paragraph (5)(A) and is satis-
factory to the Secretary (or, subject to para-
graph (3), the State); and 
‘‘(B) agrees to comply with any condition 
of operation and any limitations specified by the 
Secretary as a requirement for such waiver, in-
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cluding the conditions and limitations specified 
under paragraph (5). 
‘‘(2) INELIGIBLE PHARMACIES.—A pharmacy or 
pharmacist required to be registered under section 
510 for purposes of compounding a drug product is 
not eligible for a waiver under this subsection for 
such purposes. 
‘‘(3) TYPES
OF
PHARMACIES
ELIGIBLE
FOR 
WAIVER.—Subject to paragraph (2), the Secretary 
shall specify types of pharmacies and pharmacists 
that are eligible for a waiver under this subsection, 
and shall include the following types: 
‘‘(A) Any pharmacy or pharmacist within a 
hospital system that is compounding drug prod-
ucts exclusively for dispensing to patients with-
in that hospital system. 
‘‘(B) Any pharmacy or pharmacist that 
compounds sterile drug products. 
‘‘(C) Any pharmacy or pharmacist that 
compounds drug products in limited quantities 
before the receipt of a valid prescription for an 
individual patient who is located in the same 
State as the pharmacy or pharmacist, based on 
a history of the pharmacy or pharmacist receiv-
ing such valid prescription. 
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‘‘(4) WAIVERS BY STATES ALLOWED.— 
‘‘(A) 
MEMORANDUM
OF
UNDER-
STANDING.—The Secretary may authorize a 
State to grant waivers under paragraph (1) to 
pharmacies and pharmacists in such State pur-
suant to a memorandum of understanding en-
tered into between the Secretary and the 
State— 
‘‘(i) ensuring, to the Secretary’s satis-
faction, that the State’s program for 
granting waivers will be implemented in 
accordance with the requirements of this 
section (including the application of dif-
ferent requirements for different types of 
pharmacies, as specified under paragraph 
(5)(B)); and 
‘‘(ii) including such other information 
and assurances as the Secretary may re-
quire. 
‘‘(B) 
DETERMINATION.—The 
Secretary 
shall establish criteria and a process for deter-
mining whether to authorize a State to grant 
waivers under paragraph (1). 
‘‘(C) SCOPE OF AUTHORIZATION.—In au-
thorizing a State to grant waivers under sub-
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paragraph (A), the Secretary may limit such 
authority to apply only with respect to certain 
types of pharmacies and pharmacists specified 
under paragraph (3). 
‘‘(D) LIMITATION.—A waiver granted by a 
State to a pharmacy or pharmacist under sub-
paragraph (A) shall only apply with respect to 
compounded drug products sold or dispensed 
within such State. 
‘‘(5) APPLICATIONS; REQUIREMENTS.— 
‘‘(A) IN
GENERAL.—For each type of 
pharmacy or pharmacist specified under para-
graph (3), the Secretary shall specify, in the 
regulations under subsection (j), the following: 
‘‘(i) The information that is required 
to be included in an application for a waiv-
er under paragraph (1). 
‘‘(ii) The circumstances necessary to 
support the approval of such an applica-
tion by the Secretary, or by a State that 
is authorized to grant waivers under para-
graph (4), including the criteria that shall 
be used to evaluate such an application. 
‘‘(iii) The conditions of operation, in-
cluding good manufacturing practices and 
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requirements for third-party testing, appli-
cable to the compounding of drugs under 
such a waiver. 
‘‘(iv) Any limitations on the activities 
that a pharmacy or pharmacist may en-
gage in under such a waiver. 
‘‘(v) The duration (and renewability) 
of such a waiver. 
‘‘(B) SPECIFICITY
TO
TYPES
OF
PHAR-
MACIES AND PHARMACISTS.—In establishing re-
quirements under subparagraph (A), the Sec-
retary shall make the requirements specific to 
each type of pharmacy and pharmacist specified 
by the Secretary under paragraph (3). 
‘‘(e) WAIVER OF REQUIREMENT REGARDING COPIES 
OF COMMERCIALLY AVAILABLE DRUG.— 
‘‘(1) WAIVER AUTHORITY.—The Secretary may, 
with respect to a drug product sold or dispensed by 
a pharmacy or pharmacist, waive the requirement of 
subsection (a)(7) if the Secretary determines that 
compounding the drug product is necessary to pro-
tect public health or well-being. 
‘‘(2) DURATION.—The duration of a waiver 
under paragraph (1) shall not exceed 1 year, unless 
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the Secretary determines that an extension is nec-
essary to protect public health or well-being. 
‘‘(3) WAIVERS BY STATES PROHIBITED.—The 
Secretary may not authorize any State to grant 
waivers under this subsection. 
‘‘(f) INSPECTIONS.—The facilities of any pharmacy 
or pharmacist compounding drug products pursuant to a 
waiver under subsection (c), (d), or (e) shall be subject 
to inspection under section 704 for purposes of deter-
mining compliance with the provisions of this Act applica-
ble to such compounding. 
‘‘(g) CANCELLATION OF WAIVER.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
notice at least 30 days before cancelling a waiver 
under subsection (c), (d), or (e). 
‘‘(2) EXCEPTION
FOR
PUBLIC
HEALTH
AND 
SAFETY.—The Secretary may cancel a waiver with-
out regard to paragraph (1) in order to prevent an 
adverse impact on public health or safety. 
‘‘(h) LABELING.—The labeling of any drug product 
compounded pursuant to subsection (a) shall include the 
following statement: ‘This drug has not been tested for 
safety and effectiveness and is not approved by the FDA. 
Serious adverse reactions to this drug should be reported 
to the pharmacy where it was received and the FDA at 
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lllll.’ The blank shall specify a phone number and 
a Web site, to be provided by the Secretary for purposes 
of this subsection. 
‘‘(i) REPORTING
BY
PHARMACISTS
AND
PHYSI-
CIANS.— 
‘‘(1) ADVERSE
EVENT.—If a pharmacist or 
physician compounding a drug product pursuant to 
this section becomes aware of any adverse event as-
sociated with the use of such product, not later than 
10 calendar days after becoming so aware, the phar-
macist or physician shall report such adverse event 
to the Secretary. 
‘‘(2) INFORMATION RELATED TO RISK OF IN-
JURY
OR
DEATH.—If a pharmacist or physician 
compounding a drug product pursuant to this sec-
tion becomes aware of information concerning any 
bacteriological, fungal, or other contamination; any 
significant chemical, physical, or other change; or 
any deterioration of a compounded drug product 
that has already been distributed by the pharmacist 
or physician, that could cause serious injury or 
death, not later than 5 calendar days after becoming 
so aware, the pharmacist or physician shall report 
such information to the Secretary. 
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‘‘(j) REGULATIONS.—The Secretary shall promulgate 
regulations for carrying out this section, which shall in-
clude the following: 
‘‘(1) The types of pharmacies and pharmacists 
specified pursuant to subsection (d)(3). 
‘‘(2) The criteria and process for determining 
whether a State may provide a waiver under sub-
section (d)(4). 
‘‘(3) The information specified under subsection 
(d)(5)(A). 
‘‘(4) The requirements applicable to different 
types of pharmacies and pharmacists under sub-
section (d)(5). 
‘‘(5) The requirements for inspections under 
subsection (f). 
‘‘(k) DEFINITIONS.—In this section: 
‘‘(1) The term ‘copy of a commercially available 
drug product’ does not include a drug product in 
which there is a change, made for an identified indi-
vidual patient, which produces for that patient a sig-
nificant difference, as determined by the prescribing 
practitioner, between the compounded drug and the 
comparable commercially available drug product. 
‘‘(2) The term ‘compounding’ does not include 
mixing, reconstituting, or other such acts that are 
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performed in accordance with directions contained in 
approved labeling provided by the product’s manu-
facturer and other manufacturer directions con-
sistent with that labeling.’’. 
(b) MISBRANDING.—Section 502 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amend-
ed by adding at the end the following: 
‘‘(bb) If it is a drug product compounded pursuant 
to section 503A and its labeling does not include the state-
ment required by section 503A(h).’’. 
(c) 
CONFORMING
AMENDMENT.—Section 
704(a)(2)(A) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(a)(2)(A)) is amended by inserting 
‘‘subject to section 503A,’’ before ‘‘pharmacies which 
maintain establishments’’. 
(d) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary shall pro-
mulgate final regulations for carrying out the amendments 
made by subsections (a), (b), and (c). 
(e) EFFECTIVE DATE.—The amendments made by 
subsections (a), (b), and (c) shall take effect on the date 
that is 1 year after the date of the enactment of this Act. 
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SEC. 3. REGISTRATION AND INSPECTION OF MANUFACTUR-
ERS COMPOUNDING DRUG PRODUCTS. 
(a) REGISTRATION.—Section 510(g) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(g)) is 
amended by adding at the end the following: ‘‘With respect 
to compounding drugs, the exemption in paragraph (1) 
does not apply with respect to any pharmacy to the extent 
to which the pharmacy is, in effect, manufacturing such 
drugs, as determined by the Secretary, taking into consid-
eration the extent to which such pharmacy sells the drugs 
across State lines, the quantity of the drugs sold, and any 
other factors determined appropriate by the Secretary.’’. 
(b) INSPECTION.—Section 704(a)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(2)) is 
amended by adding at the end the following flush text: 
‘‘With respect to compounding drugs, the exemption 
in subparagraph (A) does not apply with respect to 
any pharmacy to the extent to which the pharmacy 
is, in effect, manufacturing such drugs, as deter-
mined by the Secretary, taking into consideration 
the extent to which such pharmacy sells the drugs 
across State lines, the quantity of the drugs sold, 
and any other factors determined appropriate by the 
Secretary.’’. 
(c) REGULATIONS.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
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and Human Services shall promulgate regulations for car-
rying out the amendments made by subsections (a) and 
(b). 
(d) EFFECTIVE DATE.—The amendment made by 
subsection (a) shall take effect on the date that is 1 year 
after the date of the enactment of this Act. 
Æ 
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