Page:United States Statutes at Large Volume 119.djvu/2000

 119 STAT. 1982

Deadline.

VerDate 14-DEC-2004

13:51 Oct 26, 2006

PUBLIC LAW 109–60—AUG. 11, 2005

‘‘(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 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 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 ultimate 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 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 reported to the State under subsection (d).

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