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Regulations Regarding Concerta Dispensing

Concerta is the brand name for the generic prescription drug methylphenidate, or MHP. It is similar to amphetamine, but is less potent. Concerta works to increase the activity of the central nervous system to increase and maintain alertness. It is used in the treatment of attention deficit disorder, also known as ADHD, in children and adults. Federal and state regulations control the dispensing of this Schedule II controlled substance.

  1. Written Prescriptions

    • All prescriptions for Concerta must be written in ink, indelible pencil or typewritten, and signed manually by a licensed professional. Signature stamps are illegal. A designated person may prepare the prescription, but it can only be signed by the practitioner. The professional must ensure that the prescription conforms to all federal laws and regulations.

    Prescription Label

    • Each prescription must have an affixed label with the name of the patient and the doctor. The label must also contain the pharmacy name, address and date of the initial dispensing. The prescription number must be prominently placed and easily read. It must also have directions for use. The label must display a precautionary statement required by the Food and Drug Administration that details warnings about the transfer of the drug to anyone other than the patient.

    Amount Limits

    • Most states have some restrictions on the amount of medication prescribed, but there are no federal regulations for Schedule II substances. It is up to the physician to decide the supply amount. For example, the patient could be given a three-month or six-month supply.

    Prescription Refills

    • Prescriptions for Schedule II controlled substances cannot be refilled without a new prescription from the physician. Some practitioners write several prescriptions on the same day that can only be filled on different dates, but most require regular doctor visits before more medication is prescribed. The prescription cannot be filled for more than the prescribed amount at any one time.

    Time Limits

    • According to the American Pharmacists Association, some states have placed restrictions on the amount of time a prescription is valid. Federal law does not specify a time limit for filling a prescription for a Schedule II controlled substance, but most expire six months after the date written.

    Pharmacist Responsibility

    • Proper records of Schedule II drugs must be held in a central database and closely monitored. Pharmacists have the responsibility to enforce federal and state regulations regarding all Schedule II controlled substances and report any discrepancies to authorities.

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