SEC. 2. PRESCRIPTION SAFETY ALERT SYSTEM TO HELP 
PREVENT ABUSE AND MISUSE OF PRESCRIP-
TION DRUGS. 
The Federal Food, Drug, and Cosmetic Act is amend-
ed by inserting after section 505–1 of such Act (21 U.S.C. 
355–1) the following new section: 
‘‘SEC. 505–2. PRESCRIPTION SAFETY ALERT SYSTEM TO 
PREVENT ABUSE AND MISUSE. 
‘‘(a) IN GENERAL.—For the purpose of combating 
the national prescription drug abuse epidemic, the Sec-
retary shall, with respect to covered drug products, estab-
lish and maintain an electronic system, to be known as 
the Prescription Safety Alert System, that— 
‘‘(1) reviews patient prescription and dispensing 
history through pharmaceutical claims data trans-
actions described in section 1173(a)(2) of the Social 
Security Act and developed by a standard setting or-
ganization; 
‘‘(2) collects, maintains, and is capable of pro-
viding to dispensers, within a dispenser’s ordinary 
clinical workflow, information about a patient’s pre-
scription and dispensing history; 
‘‘(3) delivers information about a patient’s pre-
scription and dispensing history in summary form, 
that allows the dispenser to evaluate the risk of mis-
use, abuse, addiction, overdose, and drug-drug inter-
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actions associated with filling the prescription 
sought by a patient based upon such patient’s pre-
scription and dispensing history for covered drug 
products; 
‘‘(4) provides to dispensers the information de-
scribed in paragraphs (2) and (3) in real-time; 
‘‘(5) allows dispensers to obtain access to a pa-
tient’s prescription and dispensing history; and 
‘‘(6) requires dispensers as a condition on using 
such System to have a written use agreement with 
such System to— 
‘‘(A) allow such System to access required 
data elements about the dispenser’s patients to 
ensure that the prescribing and dispensing his-
tory of such patients is updated on a real-time 
basis in such System; and 
‘‘(B) receive information about a patient’s 
prescription and dispensing history in summary 
form from such System. 
‘‘(b) IMPLEMENTATION.—Beginning not later than 
12 months after the date of enactment of this Act, the 
Secretary shall require, pursuant to section 505–1, that 
covered drug products be dispensed using the Prescription 
Safety Alert System to help combat the national prescrip-
tion drug abuse epidemic. 
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‘‘(c) PURPOSES
OF
COLLECTING
AND
MAKING 
AVAILABLE
INFORMATION.—The Prescription Safety 
Alert System shall collect and make available information 
only for the following purposes: 
‘‘(1) Providing dispensers with information to 
evaluate the risk of misuse, abuse, addiction, over-
dose, and drug-drug interactions associated with a 
covered drug product based upon a patient’s pre-
scription and dispensing history. 
‘‘(2) Providing the Secretary with aggregate in-
formation on an annualized basis regarding the 
number of patients or prescriptions flagged by such 
System or a dispenser as potentially presenting a 
risk of misuse, abuse, addiction, overdose, or drug- 
drug interactions, and other aggregate information, 
where the Secretary deems the provision of such in-
formation to be appropriate. 
‘‘(d) RULE
OF CONSTRUCTION
ON LIABILITY.— 
Nothing in this section shall be construed to create or 
serve as the basis for additional liability for any entity con-
necting to the System, beyond existing applicable State 
and Federal laws and regulations. 
‘‘(e) WAIVERS.— 
‘‘(1) IN GENERAL.—The Secretary may waive 
the requirements of this section in whole or in part 
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if the Secretary determines that compliance with 
such requirements is not feasible due to— 
‘‘(A) a public health emergency declared 
pursuant to section 319 of the Public Health 
Service Act; or 
‘‘(B) a natural disaster, a power disrup-
tion, or other extenuating circumstances. 
‘‘(2) GUIDANCE.—Not later than 12 months 
after the date of enactment of this section, the Sec-
retary shall issue guidance to clarify the cir-
cumstances under which waivers will be granted 
under paragraph (1). 
‘‘(f) RELATION TO PRIVACY LAW.— 
‘‘(1) APPROPRIATE
SAFEGUARDS.—The Sec-
retary shall take appropriate measures to safeguard 
the privacy and cybersecurity of the data in the Pre-
scription Safety Alert System. 
‘‘(2) DISPENSERS.—The use of protected health 
information, or the disclosure to the Prescription 
Safety Alert System of protected health information, 
by a dispenser pursuant to requirements prescribed 
under this section is deemed to be a use or disclo-
sure, as applicable, required by law and therefore 
permitted, without the authorization of the indi-
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vidual, under section 164.512(a) of title 45, Code of 
Federal Regulations (or any successor regulations). 
‘‘(3) DISCLOSURE
BY
PRESCRIPTION
SAFETY 
ALERT SYSTEM.—The use of protected health infor-
mation, or the disclosure to a dispenser of protected 
health information, by the Prescription Safety Alert 
System pursuant to requirements prescribed under 
this section is deemed to be a use or disclosure, as 
applicable, required by law and therefore permitted, 
without authorization of the individual, under sec-
tion 164.512(a) of title 45 of the Code of Federal 
Regulations (or any successor regulations). 
‘‘(4) DEFINITIONS.—In this subsection: 
‘‘(A) The term ‘protected health informa-
tion’ has the meaning given to that term in sec-
tion 160.103 of title 45, Code of Federal Regu-
lations (or any successor regulations). 
‘‘(B) The term ‘required by law’ has the 
meaning given to that term in section 164.103 
of title 45 of the Code of Federal Regulations 
(or any successor regulations). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) The term ‘covered drug product’ means 
any drug product that— 
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‘‘(A) has been approved for any use under 
section 505 of this Act or section 351 of the 
Public Health Service Act; and 
‘‘(B) has been included in a list of drugs 
published by the Secretary in the Federal Reg-
ister as presenting a risk of misuse, abuse, ad-
diction, overdose, or drug-drug interactions ne-
cessitating inclusion in the Prescription Safety 
Alert System, so long as the Secretary provided 
no less than 30 days for public comment before 
finalizing the inclusion of such drug product in 
such list. 
‘‘(2) The term ‘dispenser’ means a person who 
is licensed in accordance with State law to engage 
in the practice of pharmacy to dispense covered drug 
products directly to patients or their caregivers, ex-
cept such term does not include a closed-system 
pharmacy. 
‘‘(3) The term ‘closed-system pharmacy’ means 
any facility, including a nursing home, correctional 
facility, adult congregate living facility, or other cus-
todial care facility, that is licensed by law to engage 
in the practice of pharmacy that distributes or dis-
penses covered drug products utilizing a closed deliv-
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ery system where prescriptions are individually pre-
pared for a custodial consumer. 
‘‘(4) The term ‘prescription and dispensing his-
tory’ means a patient’s history, dating back a min-
imum of 12 months, or such period as the Secretary 
deems appropriate, of receiving, filling, or attempt-
ing to receive or fill, prescriptions for covered drug 
products, including specific data elements, as appli-
cable to any particular patient or prescription, in-
cluding— 
‘‘(A) a description of the drug dispensed or 
attempted to be filled; 
‘‘(B) pharmacy national provider identifier 
(NPI); 
‘‘(C) prescription (Rx) number; 
‘‘(D) fill number; 
‘‘(E) other applicable coverage code; 
‘‘(F) date or dates of service; 
‘‘(G) prescriber identifiers; 
‘‘(H) patient information; 
‘‘(I) third party identifiers; and 
‘‘(J) such other information the Secretary 
deems appropriate by guidance. 
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‘‘(5) The term ‘standard setting organization’ 
has the meaning given to such term in section 
1171(8) of the Social Security Act.’’. 
Æ 
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