ASSEMBLY HEALTH AND SENIOR SERVICES COMMITTEE
ASSEMBLY COMMITTEE SUBSTITUTE FOR
ASSEMBLY, No. 2590
STATE OF NEW JERSEY
DATED: MAY 10, 2012
The Assembly Health and Senior Services Committee reports favorably a committee substitute for Assembly Bill No. 2590.
The purpose of this committee substitute is to reduce opioid abuse by ensuring that when a practitioner prescribes an opioid drug that incorporates tamper resistance technology, the pharmacy will not routinely substitute a drug lacking that technology.
The substitute provides specifically as follows:
· The Director of the Division of Consumer Affairs (DCA) in the Department of Law and Public Safety is to publish on the DCA website a list of opioid drugs approved by the federal Food and Drug Administration (FDA) that incorporate tamper resistance technology, as demonstrated by at least one human tampering or abuse-potential study. The director is to include on the list only those opioid drugs for which the manufacturer submits an application that conforms to the requirements of the substitute.
· The application submitted by the manufacturer of an opioid drug is to include a report from a testing laboratory that is accredited by: the American Association for Laboratory Accreditation; the International Organization for Standardization as an ISO 17025:2005 or later testing laboratory; or a nationally recognized agency that complies with the current good manufacturing practice requirements of the FDA pursuant to 21 C.F.R. s.210.
· The testing laboratory will not, although retained or commissioned by the manufacturer to produce the required report, otherwise be affiliated with or subject to the control of the manufacturer and will not be the same entity that conducted or produced the human tampering or abuse-potential study.
· For an opioid drug to be included on the list published by DCA, the report by the testing laboratory must confirm that the drug: is interchangeable with another opioid drug approved by the FDA, whether it is a brand name or generic drug product; incorporates tamper resistance technology, as demonstrated by at least one human tampering or abuse-potential study determined to be valid by the laboratory; and incorporates tamper resistance technology in the same dosage form as the tamper resistance technology of the drug with which it is interchangeable.
· The director is to include an opioid drug on the list that is published on the DCA website solely on the basis of the laboratory report, and the manufacturer is to bear all costs of the laboratory report.
· The director is to establish, by regulation, the application fee to be paid by a manufacturer that submits an application, and the fee is to be paid at the time the study is submitted. The fee is to be reasonable and not exceed an amount reasonably necessary to cover the cost of reviewing and publishing the list.
· A drug included on the list is not required to bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential at the time it is listed.
· A pharmacist is prohibited from substituting an opioid drug that is included on the list published by DCA with a drug that is not included on the list.
· Subject to the provisions of section 8 of P.L.1977, c.240 (C.24:6E-7), a pharmacist may substitute an opioid drug that is included on the published list with another drug that is on the list and is otherwise interchangeable, whether it is a brand name or generic drug product, provided that the pharmacist verifies, prior to making the substitution, that the substitute drug is included on the published list and is identified on the published list as incorporating tamper resistance technology in the same dosage form as the tamper resistance technology of the drug for which it is to be substituted.
· If the prescription does not specify an opioid drug that is included on the published list, the provisions of the substitute would not apply.
· The substitute defines “opioid drug” to mean a drug in the opioid drug class that is prescribed to treat moderate to severe pain or other conditions, whether in immediate release or extended release form, and whether or not combined with other drug substances to form a single dosage form.
· The substitute takes effect on the first day of the fourth month after the date of enactment.