H. R. 1132—3
‘‘(viii) penalties for the unauthorized use and 
disclosure of information maintained in the State con-
trolled substance monitoring program in violation of 
applicable State law or regulation; 
‘‘(ix) information on the relevant State laws, poli-
cies, and procedures, if any, regarding purging of 
information from the database; and 
‘‘(x) assurances of compliance with all other 
requirements of this section; or 
‘‘(B) with respect to a State that intends to use funds 
under the grant as provided for in subsection (a)(1)(B)—
‘‘(i) a budget cost estimate for the controlled sub-
stance monitoring program to be improved under the 
grant; 
‘‘(ii) a plan for ensuring that the State controlled 
substance monitoring program is in compliance with 
the criteria and penalty requirements described in 
clauses (ii) through (viii) of subparagraph (A); 
‘‘(iii) a plan to enable the State controlled sub-
stance monitoring program to achieve interoperability 
with at least one other State controlled substance moni-
toring program; and 
‘‘(iv) assurances of compliance with all other 
requirements of this section or a statement describing 
why such compliance is not feasible or is contrary 
to the best interests of public health in such State. 
‘‘(2) STATE LEGISLATION.—As part of an application under 
paragraph (1), the Secretary shall require a State to dem-
onstrate that the State has enacted legislation or regulations 
to permit the implementation of the State controlled substance 
monitoring program and the imposition of appropriate penalties 
for the unauthorized use and disclosure of information main-
tained in such program. 
‘‘(3) INTEROPERABILITY.—If a State that submits an applica-
tion under this subsection geographically borders another State 
that is operating a controlled substance monitoring program 
under subsection (a)(1) on the date of submission of such 
application, and such applicant State has not achieved inter-
operability for purposes of information sharing between its 
monitoring program and the monitoring program of such border 
State, such applicant State shall, as part of the plan under 
paragraph (1)(B)(iii), describe the manner in which the 
applicant State will achieve interoperability between the moni-
toring programs of such States. 
‘‘(4) APPROVAL.—If a State submits an application in accord-
ance with this subsection, the Secretary shall approve such 
application. 
‘‘(5) RETURN
OF
FUNDS.—If the Secretary withdraws 
approval of a State’s application under this section, or the 
State chooses to cease to implement or improve a controlled 
substance monitoring program under this section, a funding 
agreement for the receipt of a grant under this section is 
that the State will return to the Secretary an amount which 
bears the same ratio to the overall grant as the remaining 
time period for expending the grant funds bears to the overall 
time period for expending the grant (as specified by the Sec-
retary at the time of the grant).
H. R. 1132—4
‘‘(d) REPORTING REQUIREMENTS.—In implementing or improving 
a controlled substance monitoring program under this section, a 
State shall comply, or with respect to a State that applies for 
a grant under subsection (a)(1)(B) submit to the Secretary for 
approval a statement of why such compliance is not feasible or 
is contrary to the best interests of public health in such State, 
with the following: 
‘‘(1) The State shall require dispensers to report to such 
State each dispensing in the State of a controlled substance 
to an ultimate user not later than 1 week after the date 
of such dispensing. 
‘‘(2) The State may exclude from the reporting requirement 
of this subsection—
‘‘(A) the direct administration of a controlled substance 
to the body of an ultimate user; 
‘‘(B) the dispensing of a controlled substance in a 
quantity limited to an amount adequate to treat the ulti-
mate user involved for 48 hours or less; or 
‘‘(C) the administration or dispensing of a controlled 
substance in accordance with any other exclusion identified 
by the Secretary for purposes of this paragraph. 
‘‘(3) The information to be reported under this subsection 
with respect to the dispensing of a controlled substance shall 
include the following: 
‘‘(A) Drug Enforcement Administration Registration 
Number (or other identifying number used in lieu of such 
Registration Number) of the dispenser. 
‘‘(B) Drug Enforcement Administration Registration 
Number (or other identifying number used in lieu of such 
Registration Number) and name of the practitioner who 
prescribed the drug. 
‘‘(C) Name, address, and telephone number of the ulti-
mate user or such contact information of the ultimate user 
as the Secretary determines appropriate. 
‘‘(D) Identification of the drug by a national drug code 
number. 
‘‘(E) Quantity dispensed. 
‘‘(F) Number of refills ordered. 
‘‘(G) Whether the drug was dispensed as a refill of 
a prescription or as a first-time request. 
‘‘(H) Date of the dispensing. 
‘‘(I) Date of origin of the prescription. 
‘‘(J) Such other information as may be required by 
State law to be reported under this subsection. 
‘‘(4) The State shall require dispensers to report information 
under this section in accordance with the electronic format 
specified by the Secretary under subsection (h), except that 
the State may waive the requirement of such format with 
respect to an individual dispenser that is unable to submit 
such information by electronic means. 
‘‘(e) DATABASE.—In implementing or improving a controlled sub-
stance monitoring program under this section, a State shall comply 
with the following: 
‘‘(1) The State shall establish and maintain an electronic 
database containing the information reported to the State under 
subsection (d).
H. R. 1132—5
‘‘(2) The database must be searchable by any field or com-
bination of fields. 
‘‘(3) The State shall include reported information in the 
database in a manner consistent with criteria established by 
the Secretary, with appropriate safeguards for ensuring the 
accuracy and completeness of the database. 
‘‘(4) The State shall take appropriate security measures 
to protect the integrity of, and access to, the database. 
‘‘(f) USE AND DISCLOSURE OF INFORMATION.—
‘‘(1) IN
GENERAL.—Subject to subsection (g), in imple-
menting or improving a controlled substance monitoring pro-
gram under this section, a State may disclose information from 
the database established under subsection (e) and, in the case 
of a request under subparagraph (D), summary statistics of 
such information, only in response to a request by—
‘‘(A) a practitioner (or the agent thereof) who certifies, 
under the procedures determined by the State, that the 
requested information is for the purpose of providing med-
ical or pharmaceutical treatment or evaluating the need 
for such treatment to a bona fide current patient; 
‘‘(B) any local, State, or Federal law enforcement, nar-
cotics control, licensure, disciplinary, or program authority, 
who certifies, under the procedures determined by the 
State, that the requested information is related to an indi-
vidual investigation or proceeding involving the unlawful 
diversion or misuse of a schedule II, III, or IV substance, 
and such information will further the purpose of the inves-
tigation or assist in the proceeding; 
‘‘(C) the controlled substance monitoring program of 
another State or group of States with whom the State 
has established an interoperability agreement; 
‘‘(D) any agent of the Department of Health and 
Human Services, a State medicaid program, a State health 
department, or the Drug Enforcement Administration who 
certifies that the requested information is necessary for 
research to be conducted by such department, program, 
or administration, respectively, and the intended purpose 
of the research is related to a function committed to such 
department, program, or administration by law that is 
not investigative in nature; or 
‘‘(E) an agent of the State agency or entity of another 
State that is responsible for the establishment and mainte-
nance of that State’s controlled substance monitoring pro-
gram, who certifies that—
‘‘(i) the State has an application approved under 
this section; and 
‘‘(ii) the requested information is for the purpose 
of implementing the State’s controlled substance moni-
toring program under this section. 
‘‘(2) DRUG DIVERSION.—In consultation with practitioners, 
dispensers, and other relevant and interested stakeholders, a 
State receiving a grant under subsection (a)—
‘‘(A) shall establish a program to notify practitioners 
and dispensers of information that will help identify and 
prevent the unlawful diversion or misuse of controlled sub-
stances; and