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Questions & Answers
________________________________
Issuance of Multiple Prescriptions for
Schedule II Controlled Substances
1. What does this rule allow a practitioner to do?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#1#1>
2. What are the requirements for the issuance of multiple
prescriptions for schedule II controlled substances?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#2#2>
3. Does this rule require or mandate a practitioner to issue
multiple prescriptions for schedule II controlled substances?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#3#3>
4. What is the effective date of the rule change?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#4#4>
5. Is there a limit on the number of schedule II dosage units a
practitioner can prescribe to a patient?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#5#5>
6. Is there a limit on the number of separate prescriptions per
schedule II substance that may be issued during the 90-day time period?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#6#6>
7. How is the issuance of multiple schedule II prescriptions
different than issuing a refill of a schedule II prescription?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#7#7>
8. Is post-dating of multiple prescriptions allowed?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#8#8>
9. What is expected of the pharmacist?
<http://www.deadiversion.usdoj.gov/faq/mult_rx_faq.htm#9#9>
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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)
<http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_05.htm> .
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).
<http://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm>
________________________________
Providers and interested Parties, please note the highlighted blue
question regarding shedule II prescription physician orders. This is
federal and the state law is the same. 90 Days is the allowed days of a
prescription order but can be less at the physician's discretion. The
CRMA curriculum will be corrected to reflect this.
Carol Davis HSC
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Carol A. Davis HSC
Division of Licensing & Regulatory Services
41 Anthony Avenue
Augusta, Maine 04333
Phone: 207-287-9261
1-800-791-4080
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