feasible or is contrary to the best interests 
of public health in such State. 
‘‘(2) STATE LEGISLATION.—As part of an appli-
cation under paragraph (1), the Secretary shall re-
quire a State to demonstrate that the State has en-
acted legislation or regulations to permit the imple-
mentation of the State controlled substance moni-
toring program and the imposition of appropriate 
penalties for the unauthorized use and disclosure of 
information maintained in such program. 
‘‘(3) INTEROPERABILITY.—If a State that sub-
mits an application under this subsection geographi-
cally borders another State that is operating a con-
trolled substance monitoring program under sub-
section (a)(1) on the date of submission of such appli-
cation, and such applicant State has not achieved 
interoperability 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 appli-
cant State will achieve interoperability between the 
monitoring programs of such States.
‘‘(4) APPROVAL.—If a State submits an applica-
tion in accordance with this subsection, the Secretary 
shall approve such application. 
‘‘(5) RETURN OF FUNDS.—If the Secretary with-
draws 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 re-
ceipt 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 speci-
fied by the Secretary at the time of the grant). 
‘‘(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 con-
trolled 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 con-
trolled substance to the body of an ultimate user; 
‘‘(B) the dispensing of a controlled sub-
stance in a quantity limited to an amount ade-
quate to treat the ultimate 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 con-
trolled substance shall include the following: 
‘‘(A) Drug Enforcement Administration 
Registration Number (or other identifying num-
ber used in lieu of such Registration Number) of 
the dispenser. 
‘‘(B) Drug Enforcement Administration 
Registration Number (or other identifying num-
ber used in lieu of such Registration Number)
and name of the practitioner who prescribed the 
drug. 
‘‘(C) Name, address, and telephone number 
of the ultimate user or such contact information 
of the ultimate user as the Secretary determines 
appropriate. 
‘‘(D) Identification of the drug by a na-
tional 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 re-
quired 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 re-
quirement of such format with respect to an indi-
vidual dispenser that is unable to submit such infor-
mation by electronic means.
‘‘(e) DATABASE.—In implementing or improving a 
controlled substance 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 re-
ported to the State under subsection (d). 
‘‘(2) The database must be searchable by any 
field or combination of fields. 
‘‘(3) The State shall include reported informa-
tion in the database in a manner consistent with cri-
teria established by the Secretary, with appropriate 
safeguards for ensuring the accuracy and complete-
ness 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 
implementing or improving a controlled substance 
monitoring program 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 medical or pharma-
ceutical treatment or evaluating the need for 
such treatment to a bona fide current patient; 
‘‘(B) any local, State, or Federal law en-
forcement, narcotics control, licensure, discipli-
nary, or program authority, who certifies, under 
the procedures determined by the State, that the 
requested information is related to an individual 
investigation or proceeding involving the unlaw-
ful diversion or misuse of a schedule II, III, or 
IV substance, and such information will further 
the purpose of the investigation 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 interoper-
ability agreement; 
‘‘(D) any agent of the Department of Health 
and Human Services, a State medicaid pro-
gram, a State health department, or the Drug 
Enforcement Administration who certifies that 
the requested information is necessary for re-