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Issuance of Multiple Prescriptions for Schedule II Controlled Substances

Questions & Answers - Issuance of Multiple Prescriptions for Schedule II Controlled Substances

What does this rule allow a practitioner to do?

What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances?

Does this rule require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances?

What is the effective date of the rule change?

Is there a limit on the number of schedule II dosage units a practitioner can prescribe to a patient?

Is there a limit on the number of separate prescriptions per schedule II substance that may be issued during the 90-day time period?

How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription?

Is post-dating of multiple prescriptions allowed?

What is expected of the pharmacist?


Q. What does this rule allow a practitioner to do?

A. A practitioner may provide individual patients with multiple prescriptions for the same schedule II controlled substance to be filled sequentially. The combined effect of these multiple prescriptions is to allow the patient to receive, over time, up to a 90-day supply of that controlled substance.

Q. What are the requirements for the issuance of multiple prescriptions for schedule II controlled substances?

A. Requirements for issuance:

- Each prescription issued is for a legitimate medical purpose by an individual practitioner acting in the usual course of his/her professional practice.

- The individual practitioner must provide written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription

- The issuance of multiple prescriptions is permissible under applicable state laws.

- The individual practitioner complies fully with all other applicable requirements under the Controlled Substances Act and implementing regulations, as well as any additional requirements under state law.

Q. Does this rule require or mandate a practitioner to issue multiple prescriptions for schedule II controlled substances?

A. No. This rule does not require individual practitioners to issue multiple prescriptions or to see their patients only once every 90 days.

Q. What is the effective date of the rule change?

A. This rule became effective on December 19, 2007.

Q. Is there a limit on the number of schedule II dosage units a practitioner can prescribe to a patient?

A. There is no federal limit as to the amount of controlled substances a practitioner can legitimately prescribe. However, if a registered practitioner issues multiple schedule II prescriptions, he /she is limited to the combined effect of allowing a patient to receive, over time, up to a 90-day supply of a particular schedule II controlled substance.

Q. Is there a limit on the number of separate prescriptions per schedule II controlled substance that may be issued for the 90-day supply?

A. The rule does not stipulate how many separate prescriptions per schedule II controlled substance may be issued for the 90-day supply. It is up to the practitioner to determine how many separate prescriptions to be filled sequentially are needed to provide adequate medical care. For example, a practitioner may issue three 30-day schedule II prescriptions to cover a 90-day supply or he/she may issue nine prescriptions for the same schedule II controlled substance, each for a ten-day supply, having the combined effect of a 90-day supply.

Q. How is the issuance of multiple schedule II prescriptions different than issuing a refill of a schedule II prescription?

A. The issuance of refills for a schedule II controlled substance is prohibited by law. The use of multiple prescriptions for the dispensing of schedule II controlled substances, under the conditions set forth in the Final Rule, ensures that the prescriptions are treated as separate dispensing documents, not refills of an original prescription. Each separate prescription must be written for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. Each separate prescription must contain written instructions indicating the earliest date on which a pharmacy may fill each prescription.

Q. Is post-dating of multiple prescriptions allowed?

A. No. Federal regulations have always required that all prescriptions for controlled substances "be dated as of, and signed on, the day when issued." 21 CFR 1306.05(a).

Q. What is expected of the pharmacist when filling a prescription issued pursuant to this regulation?

A. Where a prescription contains instructions from the prescribing practitioner indicating that the prescription shall not be filled until a certain date, no pharmacist may fill the prescription before that date. In addition, when filling any prescription for a controlled substance, a pharmacist who fills multiple prescriptions issued in accordance with this regulation has a corresponding responsibility to ensure that each sequential prescription was issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice. 21 CFR 1306.04(a).

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