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).