all of the following:
(1) Assess whether the [minor] individual has taken or
is currently taking prescription drugs for treatment of a
substance use disorder.
(2) Discuss with the [minor and] individual or, if the
individual is a minor, with the minor and the minor's parent
or guardian or with an authorized adult, all of the
following:
(i) The risks of addiction and overdose associated
with the controlled substance containing an opioid.
(ii) The increased risk of addiction to controlled
substances to individuals suffering from mental or
substance use disorders.
(iii) The dangers of taking a controlled substance
containing an opioid with benzodiazepines, alcohol or
other central nervous system depressants.
(iv) Other information in the patient counseling
information section of the labeling for controlled
substances containing an opioid required under 21 C.F.R.
201.57(c)(18) (relating to specific requirements on
content and format of labeling for human prescription
drug and biological products described in § 201.56(b)(1))
deemed necessary by the prescriber.
(3) [Obtain] In the case of a minor, obtain written
consent for the prescription from the minor's parent or
guardian or from an authorized adult. The prescriber shall
record the consent on the form under section 52A02(b)(1)
(relating to administration). The following apply:
(i) The form must contain all of the following:
(A) The brand name or generic name and quantity
20210SB0169PN0210 - 4 -
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