RIS-Page 7
The proposed rules are expected to alter the frequency of the targeted behavior as follows:
-The public and licensees will know which substances are scheduled in this state.
-Licensees will know that if substances are stored at a health facility without an on-site pharmacy or an automated
device stocked by a pharmacy, a designated prescriber must obtain a controlled substances license for the address
where the drugs are stored.
-Licensees will understand that a separate controlled substance license is not needed for an emergency kit that
contains controlled substances.
-Licensees will further understand the records requirements for controlled substances. Specifically, licensees will
know that they must maintain, for department review, patient sales receipts and dispensing records for 90 days and
that 2 years from the date of the last dispensing, an electronic duplicate of an original paper prescription may be made
and utilized as the original prescription.
-Licensees will be aware that inventories and Schedule 2 order forms must be stored at the licensed location for the
automated device that dispenses controlled substances and that a pharmacy in control of an automated device that
dispenses controlled substances must document the manufacturer’s name, and the name and address of the facility
where the device is located.
-With regard to dispensing and administration of controlled substance prescriptions, licensees will understand that a
prescription is not required to have preprinted numbers representing the quantity next to a box or line.
-Licensees will be aware that the professional designation for the prescribing practitioner may be stored electronically
instead of written on the prescription.
-Licensees will be aware that a prescriber may seek a waiver of the electronic transmission requirements if the
prescriber can attest that he or she intends, within the next 12 months, to no longer regularly practice in the licensed
profession for financial gain or as a means of livelihood.
-The licensee will understand that a prescriber who prescribed a Schedule 2 substance in an emergency, must deliver
to the dispensing pharmacist a written prescription postmarked within 7 days of the dispensing date, or electronically
transmit the prescription under R 338.3162a.
-The licensee will know that written notification of a transfer of controlled substances must be given to the department
15 days before the transfer.
B. Describe the difference between current behavior/practice and desired behavior/practice.
The proposed rules have been written to provide clarity for licensees. The difference between current behavior and
desired behavior is as follows:
-Instead of frequently contacting the department, licensees and the public will understand that the federal schedule of
controlled substances is adopted with exceptions that are provided for in statute and rule.
-Instead of contacting the department to ask if a license is needed, candidates will know when they must apply for a
controlled substance license.
-Licensees will know the record requirements for controlled substances in that they must maintain, for department
review, patient sales receipts and dispensing records for 90 days and that 2 years from the date of the last dispensing,
an electronic duplicate of an original paper prescription may be made and utilized as the original prescription.
-Licensees will be aware that inventories and Schedule 2 order forms must be stored at the licensed location for the
automated device that dispenses controlled substances and that a pharmacy in control of an automated device that
dispenses controlled substances must document the manufacturer’s name, and the name and address of the facility
where the device is located.
- Licensees will clearly understand that a prescription is not required to have preprinted numbers representing the
quantity next to a box or line and that the professional designation for the prescribing practitioner may be stored
electronically instead of written on the prescription.
-Licensees will know when they can seek a waiver from the electronic transmission requirements.
-Licensees will know that that a prescriber must deliver a written prescription for a Schedule 2 substance, that was
written in an emergency, to the dispensing pharmacist. It must be postmarked within 7 days of the dispensing date or
transmitted under R 338.3162a.
-The licensee will know that written notification of a transfer of controlled substances must be given to the department
15 days before the transfer.
C. What is the desired outcome?
MCL 24.245(3)