‘‘(v) criteria for availability of infor-
mation and limitation on access to pro-
gram personnel; 
‘‘(vi) criteria for access to the data-
base, and procedures to ensure that infor-
mation in the database is accurate; 
‘‘(vii) criteria for the use and disclo-
sure of information, including a description 
of the certification process to be applied to 
requests for information under subsection 
(f); 
‘‘(viii) penalties for the unauthorized 
use and disclosure of information main-
tained in the State controlled substance 
monitoring program in violation of applica-
ble State law or regulation; 
‘‘(ix) information on the relevant 
State laws, policies, 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 substance monitoring program 
to be improved under the grant; 
‘‘(ii) a plan for ensuring that the 
State controlled substance monitoring pro-
gram 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 con-
trolled substance 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 in-
terests of public health in such State. 
‘‘(2) STATE LEGISLATION.—As part of an ap-
plication under paragraph (1), the Secretary shall 
require a State to demonstrate that the State has 
enacted legislation or regulations to permit the im-
plementation 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 ap-
plication, 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 appli-
cation in accordance with this subsection, the Sec-
retary 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 imple-
ment 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 re-
maining time period for expending the grant funds 
bears to the overall time period for expending the 
grant (as specified 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 state-
ment 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 re-
port 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 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-