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  • NJ A2997
  • Requires Division of Consumer Affairs to publish list of certain tamper-resistant opioid drugs; establishes that certain conditions be met for pharmacist to substitute for tamper-resistant opioid drug.
Introduced
(2/16/2016)
In Committee
(2/16/2016)
Crossed OverPassedSignedDead/Failed/Vetoed
2016-2017 Regular Session
This bill requires the Division of Consumer Affairs (DCA) in the Department of Law and Public Safety to publish a list of opioid drugs approved by the federal Food and Drug Administration (FDA) that incorporate tamper resistance technology, with the purpose of ensuring that when practitioners prescribe an opioid drug that incorporates tamper resistance technology, pharmacies will not routinely substitute a drug lacking that technology. Under current law, the Department of Health promulgates a list of interchangeable drug products. Pharmacies are permitted to substitute a drug product of a different brand name or a nonbrand name from this list in place of the drug specified on the prescription, provided that the prescription authorizes substitutions and the substitute drug product represents a cost savings to the consumer. This bill requires that, prior to making a substitution, pharmacists must additionally consult the DCA list to ensure that an opioid drug incorporating tamper resistance technology is not substituted by an opioid drug that does not incorporate the technology. To be included on the DCA list, a drug manufacturer must submit an application that includes a report from an accredited testing laboratory confirming the drug: (1) is interchangeable with another FDA-approved opioid drug; (2) incorporates tamper resistance technology as established by at least one human tampering or abuse-potential study determined to be valid by the testing laboratory; and (3) incorporates the tamper resistance technology in the same dosage form as the tamper resistance technology of the drug with which it is interchangeable. The testing laboratory cannot be affiliated with or subject to the control of the manufacturer, and cannot be the same entity that conducted or produced the human tampering or abuse-potential study. The manufacturer is required to bear the costs of the laboratory report. The DCA list will include opioid drugs solely on the basis of the laboratory report submitted with the manufacturer's application. The bill does not require that a drug included on the list bear a labeling claim with respect to reduction of tampering, abuse, or abuse potential. The director of the DCA will establish, by regulation, a reasonable application fee that does not exceed the cost of reviewing and publishing the DCA list. Under the bill, pharmacists may not substitute a drug included on the DCA list with a drug that is not included on the list, and may only substitute one drug on the list with another drug on the list if the substitute drug includes tamper resistance technology in the same dosage form as the drug for which it is to be substituted. The bill does not apply if the prescription does not specify an opioid drug included on the DCA list.
Not specified
Assembly Consumer Affairs Hearing (10:00 10/27/2016 Committee Room 13, 4th Floor)  (on 10/27/2016)
 
 

Date Chamber Action Description
10/27/2016 Assembly Consumer Affairs Hearing (10:00 10/27/2016 Committee Room 13, 4th Floor)
2/16/2016 A Introduced, Referred to Assembly Consumer Affairs Committee
Date Motion Yea Nay Other
None specified