I 
113TH CONGRESS 
1ST SESSION H. R. 2186 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
compounding of drug products. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 23, 2013 
Mr. MARKEY (for himself, Ms. SLAUGHTER, Mr. CLAY, and Mr. RANGEL) in-
troduced the following bill; which was referred to the Committee on En-
ergy 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 2013’’ or the 
‘‘VALID Compounding Act’’. 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
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: 
‘‘SEC. 503A. PHARMACY COMPOUNDING. 
‘‘(a) 
IN
GENERAL.—Sections 
501(a)(2)(B), 
502(f)(1), and 505 shall not apply with respect to a drug 
product if each of the following applies: 
‘‘(1) Except as provided in subsection (d), the 
drug product is compounded for an identified indi-
vidual patient based on the receipt of a prescription 
order. 
‘‘(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) In the case of a drug product that is com-
pounded using bulk substances (as defined in section 
207.3(a)(4) of title 21, Code of Federal Regulations 
(or any successor regulations)— 
‘‘(A) such bulk substances— 
‘‘(i) are components of one or more 
drugs for which an approval of an applica-
tion filed under subsection (b) or (j) of sec-
tion 505 is in effect; 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
‘‘(A) is not included in the list under sub-
section (c); and 
‘‘(B) is not withdrawn or removed from 
the market because such drug product or any 
ingredient thereof has been found to be unsafe 
or not effective. 
‘‘(7) Subject to subsection (e), the drug product 
is not a copy of a commercially available drug. 
‘‘(8) If the drug product is produced using 
high-risk sterile compounding, the drug product is 
compounded in accordance with the standards, proc-
esses, and procedures established under subsection 
(f). 
‘‘(b) LIST
OF BULK SUBSTANCES FROM WHICH 
DRUG PRODUCTS MAY BE COMPOUNDED.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(3)(A)(iii), the Secretary shall, by guidance— 
‘‘(A) develop and maintain a list of bulk 
substances from which drug products may be 
compounded; and 
‘‘(B) include in the list only bulk sub-
stances that are not described in clause (i) or 
(ii) of subsection (a)(3)(A) and may be com-
pounded to meet a medical need that cannot be 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
filled by using a bulk substance that is de-
scribed in such clause (i) or (ii); 
‘‘(C) specify for each bulk substance on the 
list under this subsection any limitation on 
compounding the bulk substance; and 
‘‘(D) specify for each bulk substance on 
the list under this subsection the particular 
medical need that is met by placing such sub-
stance on the list. 
‘‘(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 2013, 
publish an initial list under paragraph (1); and 
‘‘(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 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
of the list to the agency in each State with primary 
responsibility for regulating pharmacies. 
‘‘(5) PETITIONS.— 
‘‘(A) IN GENERAL.—In carrying out this 
subsection, the Secretary shall receive and con-
sider petitions from any person identifying a 
substance that should be added to, or removed 
from, the list under this subsection. 
‘‘(B) REQUIREMENT FOR PETITIONS SEEK-
ING TO ADD A BULK SUBSTANCE.—Any petition 
seeking to add a bulk substance to the list 
under this subsection shall specify the rea-
sons— 
‘‘(i) why the bulk substance is needed 
for a procedure or population; and 
‘‘(ii) why such need is not met by bulk 
substances that are described in clause (i) 
or (ii) of subsection (a)(3)(A). 
‘‘(C) APPROVAL
OR
DENIAL.—The Sec-
retary shall approve or deny any petition re-
ceived under this paragraph, and update the list 
under paragraph (1) accordingly, not later than 
90 days after receipt of the petition, unless an 
extension of time is mutually agreed upon by 
the Secretary and the petitioner. 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
‘‘(D) FINAL AGENCY ACTION.—A decision 
of the Secretary to approve or deny a petition 
received under this paragraph shall constitute 
final agency action subject to judicial review. 
‘‘(E) PUBLIC
POSTING.—The Secretary 
shall publically post— 
‘‘(i) all petitions received under this 
paragraph within 21 days of receipt; and 
‘‘(ii) each approval, denial, and exten-
sion under subparagraph (C) promptly. 
‘‘(c) LIST OF DRUG PRODUCTS THAT SHOULD NOT 
BE COMPOUNDED.— 
‘‘(1) IN GENERAL.—For purposes of subsection 
(a)(6), the Secretary shall, by guidance— 
‘‘(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, including extended 
release products, metered dose inhalers, 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
transdermal patches, and liposomal prod-
ucts; 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) 
APPLICABILITY
OF
CERTAIN
PROVI-
SIONS.—The provisions of paragraphs (2), (3), and 
(4) of subsection (b) shall apply with respect to the 
list under this subsection to the same extent and in 
the same manner as such provisions apply with re-
spect to the list under subsection (b). 
‘‘(3) PETITIONS.—In carrying out this sub-
section, the Secretary shall receive and consider peti-
tions from any person identifying a drug product 
that should be added to, or removed from, the list 
under this subsection. Subparagraphs (C) through 
(E) of subsection (b)(2) shall apply with respect to 
petitions under this paragraph to the same extent 
and in the same manner as such subparagraphs 
apply with respect to petitions under subsection 
(b)(5). 
‘‘(d) EXCEPTION TO REQUIREMENT OF IDENTIFIED 
INDIVIDUAL PATIENT.— 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS
‘‘(1) IN GENERAL.—A pharmacy or pharmacist 
that is not required to be registered under section 
510 may compound a drug product without regard 
to subsection (a)(1) if the pharmacy or phar-
macist— 
‘‘(A) registers with the Secretary as speci-
fied pursuant to paragraph (2); and 
‘‘(B) agrees to comply with any condition 
of operation or limitation of activity specified by 
the Secretary, including the conditions and limi-
tations specified pursuant to paragraph (2). 
‘‘(2) REGISTRATION AND REQUIREMENTS.—The 
Secretary shall specify by regulation for each type of 
pharmacy or pharmacist compounding drug products 
pursuant to the exception under this subsection— 
‘‘(A) the registration requirements for such 
pharmacy or pharmacist and the information 
that must be submitted with the registration, 
which information shall include— 
‘‘(i) the name and location of the 
pharmacy; 
‘‘(ii) the types of drugs that are com-
pounded; 
‘‘(iii) the active ingredients in each 
such drug; 
VerDate Mar 15 2010 
22:51 May 31, 2013
Jkt 029200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H2186.IH
H2186
tkelley on DSK3SPTVN1PROD with BILLS