MDPH, Drug Control Program and Board of Registration in Pharmacy
Prescribers and pharmacists have asked whether Adderall® , a Schedule II amphetamine product, may be dispensed in a sixty day supply. Adderall® has federal Food and Drug Administration (FDA) indications for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD) and narcolepsy.
The Drug Control Program and the Board of Registration in Pharmacy have determined that methylphenidate and single entity drug products containing the dextro and/or levo isomers of amphetamine may be dispensed in a sixty day supply when prescribed for an inattention and impulsivity-hyperactivity disorder or narcolepsy.
Quantity limits for controlled substances in Schedules II and III are set forth in M.G.L. 94C § 23(d) which reads, in part, as follows:
- In regard to a controlled substance in Schedule II or III, no prescription shall be filled for more than a thirty-day supply of such substance upon any single filling; provided, however, that with regard to dextro amphetamine sulfate and methyl phenidate hydrochloride, a prescription may be filled for up to a sixty-day supply of such substance upon any single filling if said substance is being used for the treatment of minimal brain dysfunction or narcolepsy.
For the purposes of fulfilling the intent of the statute, the DCP and the Board find that:
- the term "minimal brain dysfunction" means Attention Deficit/Hyperactivity Disorder (ADHD) or other accepted term for an inattention and impulsivity-hyperactivity disorder.
- the term "dextro amphetamine sulfate" means a single entity drug product that contains the dextro and/or levo isomers of amphetamine and the salts thereof.
Therefore, a patient with narcolepsy, Attention Deficit/Hyperactivity Disorder (ADHD) or other inattention and impulsivity-hyperactivity disorder may now obtain a sixty day supply of Adderall® (there is no requirement that the diagnosis be written on the prescription).