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in accordance with Section 506C, certifies 
(in such certification) that the major man-
ufacturing change for which approval is 
being sought may prevent or alleviate a 
discontinuance or interruption of such 
drug. 
‘‘(ii) BAD
FAITH
EXCEPTION.—Sub-
paragraphs (B) and (C) do not apply in 
the case of a certification which the Sec-
retary determines to be made in bad faith. 
‘‘(B) EXPEDITED
REVIEW.—If a certifi-
cation described in subparagraph (A) is sub-
mitted in connection with a supplemental appli-
cation for a major manufacturing change, the 
Secretary shall— 
‘‘(i) expedite any technical review or 
inspection necessary for consideration of 
the supplemental application; 
‘‘(ii) provide any technical assistance 
necessary to facilitate approval of the sup-
plemental application; and 
‘‘(iii) not later than 60 days after re-
ceipt of the certification, complete review 
of the supplemental application.’’. 
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SEC. 905. STUDY ON DRUG SHORTAGES. 
(a) STUDY.—The Comptroller General of the United 
States shall conduct a study to examine the cause of drug 
shortages and formulate recommendations on how to pre-
vent or alleviate such shortages. 
(b) CONSIDERATION.—In conducting the study under 
this section, the Comptroller General shall consider the 
following questions: 
(1) What are the dominant characteristics of 
drugs that have gone into actual shortage over the 
preceding three years? 
(2) Are there systemic high-risk factors (such 
as drug pricing structure, including Federal reim-
bursements, or the number of manufacturers pro-
ducing a drug product) that have led to the con-
centration of drug shortages in certain drug prod-
ucts that have made such products vulnerable to 
drug shortages? 
(3) Is there a reason why drug shortages have 
occurred primarily in the sterile injectable market 
and in certain therapeutic areas? 
(4) How have regulations, guidance documents, 
regulatory practices, and other actions of Federal 
departments and agencies (including the effective-
ness of interagency and intraagency coordination, 
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HR 5651 PCS
communication, strategic planning, and decision- 
making) affected drug shortages? 
(5) How does hoarding affect drug shortages? 
(6) How would incentives alleviate or prevent 
drug shortages? 
(7) How are healthcare providers, including 
hospitals and physicians responding to drug short-
ages, to what extent are such providers able to ad-
just care effectively to compensate for such short-
ages, and what impediments exist that hinder pro-
vider ability to adjust to such shortages? 
(c) CONSULTATION WITH STAKEHOLDERS.—In con-
ducting the study under this section, the Comptroller Gen-
eral shall consult with relevant stakeholders, including 
physicians, pharmacists, hospitals, patients, drug manu-
facturers, and other health providers. 
(d) REPORT.—Note later than 18 months after the 
date of the enactment of this Act, the Comptroller General 
shall submit a report to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on Health, Education, Labor, and Pensions of the 
Senate on the results of the study under this section. 
SEC. 906. ANNUAL REPORT ON DRUG SHORTAGES. 
Not later than 18 months after the date of the enact-
ment of this Act, and annually thereafter, the Secretary 
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of Health and Human Services shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on drug short-
ages that— 
(1) describes the communication between the 
field investigators of the Food and Drug Administra-
tion and the staff of the Center for Drug Evaluation 
and Research’s Office of Compliance and Drug 
Shortage Program, including the Food and Drug 
Administration’s procedures for enabling and ensur-
ing such communication; 
(2) describes the Food and Drug Administra-
tion’s efforts to expedite the review of new manufac-
turing sites, new suppliers, and specification changes 
to prevent or alleviate a drug shortage; 
(3) describes the coordination between the Food 
and Drug Administration and the Drug Enforce-
ment Administration on efforts to prevent or allevi-
ate drug shortages; 
(4) identifies the number of, and describes the 
instances in which the Food and Drug Administra-
tion exercised regulatory flexibility and discretion to 
prevent or alleviate a drug shortage; 
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(5) identifies the number of instances in which 
the Food and Drug Administration asked firms to 
increase production to prevent or alleviate a short-
age; 
(6) identifies the number of notifications sub-
mitted to the Secretary under section 506C of the 
Federal Food, Drug, and Cosmetic Act, as amended 
by section 901 of this Act, including the percentage 
of such notifications for a drug that is a sterile 
injectable; 
(7) describes the Food and Drug Administra-
tion’s implementation of section 506D of the Fed-
eral Food, Drug, and Cosmetic Act (relating to a 
drug shortage list), as added by section 902 of this 
Act, and identifies— 
(A) the name of each drug on the list 
under such section 506D at any point during 
the period covered by the report; 
(B) the name of each manufacturer of 
each such drug; 
(C) the reason for the shortage of each 
such drug; and 
(D) the anticipated or, if known, actual 
duration of the shortage of each such drug; 
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(8) identifies whether, and how, the Food and 
Drug Administration expedited the review of regu-
latory submissions to prevent or alleviate shortages, 
including how the Administration utilized the au-
thority in section 506A(c)(3) of the Federal Food, 
Drug, and Cosmetic Act, as added by section 904 of 
this Act; 
(9) identifies the number of certifications sub-
mitted under such section 506A(c)(3) and, for each 
such certification, whether the Food and Drug Ad-
ministration completed expedited review within 60 
days as required by subparagraph (B) of such sec-
tion 506A(c)(3); 
(10) describes the Secretary’s public engage-
ment on drug shortages with stakeholders, including 
physicians, pharmacists, patients, hospitals, drug 
manufacturers, and other health providers; and 
(11) contains the Secretary’s plan for address-
ing drug shortages in the upcoming year, including 
with respect to the issues described in paragraphs 
(1) through (10). 
SEC. 907. ATTORNEY GENERAL REPORT ON DRUG SHORT-
AGES. 
Not later than 6 months after the date of the enact-
ment of this Act, and annually thereafter, the Attorney 
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General shall submit to the Committee on Energy and 
Commerce of the House of Representatives and the Com-
mittee on the Judiciary of the Senate a report on drug 
shortages that— 
(1) identifies the number of requests received 
under section 306(h) of the Controlled Substances 
Act (as added by section 903 of this Act), the aver-
age review time for such requests, the number of re-
quests granted and denied under such section, and, 
for each of the requests denied under such section, 
the basis for such denial; 
(2) describes the coordination between the Drug 
Enforcement Administration and Food and Drug 
Administration on efforts to prevent or alleviate 
drug shortages; and 
(3) identifies drugs containing a controlled sub-
stance subject to section 306 of the Controlled Sub-
stances Act when such a drug is determined by the 
Secretary of Health and Human Services to be in 
shortage. 
SEC. 908. HOSPITAL REPACKAGING OF DRUGS IN SHORT-
AGE. 
Chapter V (21 U.S.C. 351 et seq.), as amended by 
section 902 of this Act, is further amended by inserting 
after section 506D the following: 
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‘‘SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORT-
AGE. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) DRUG.—The term ‘drug’ excludes any con-
trolled substance (as such term is defined in section 
102 of the Controlled Substances Act). 
‘‘(2) HEALTH SYSTEM.—The term ‘health sys-
tem’ means a collection of hospitals that are owned 
and operated by the same entity and that share ac-
cess to databases with drug order information for 
their patients. 
‘‘(3) REPACKAGE.—For the purposes of this 
section only, the term ‘repackage’, with respect to a 
drug, means to divide the volume of a drug into 
smaller amounts in order to— 
‘‘(A) extend the supply of a drug in re-
sponse to the placement of the drug on a drug 
shortage list described in subsection (b); and 
‘‘(B) facilitate access to the drug by hos-
pitals within the same health system. 
‘‘(b) EXCLUSION FROM REGISTRATION.—Notwith-
standing any other provision of this Act, a hospital shall 
not be considered an establishment for which registration 
is required under section 510 solely because it repackages 
a drug and transfers it to another hospital within the same 
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health system in accordance with the conditions in sub-
section (c)— 
‘‘(1) during any period in which the drug is list-
ed on the Drug Shortage List of the Food and Drug 
Administration; or 
‘‘(2) during the 60-day period following any pe-
riod described in paragraph (1). 
‘‘(c) CONDITIONS.—Subsection (b) shall only apply to 
a hospital, with respect to the repackaging of a drug for 
transfers to another hospital within the same health sys-
tem, if the following conditions are met: 
‘‘(1) DRUG FOR INTRASYSTEM USE ONLY.—In 
no case may a drug that has been repackaged in ac-
cordance with this section be sold or otherwise dis-
tributed by the health system or a hospital within 
the system to an entity or individual that is not a 
hospital within such health system. 
‘‘(2) COMPLIANCE
WITH
STATE
RULES.—Re-
packaging of a drug under this section shall be done 
in compliance with applicable State requirements in 
which the health system is located. 
‘‘(d) TERMINATION.—This section shall not apply on 
or after the date on which the Secretary issues final guid-
ance that clarifies the policy of the Food and Drug Admin-
istration regarding hospital pharmacies repackaging and 
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safely transferring repackaged drugs to other hospitals 
within the same health system during a drug shortage.’’. 
Passed the House of Representatives May 30, 2012. 
Attest: 
KAREN L. HAAS, 
Clerk. 
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Calendar No. 420 
112TH CONGRESS 
2D SESSION 
H. R. 5651 
AN ACT 
To amend the Federal Food, Drug, and Cosmetic 
Act to revise and extend the user-fee programs 
for prescription drugs and for medical devices, to 
establish user-fee programs for generic drugs and 
biosimilars, and for other purposes. 
JUNE 4, 2012 
Received; read twice and placed on the calendar 
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