Ariz. Admin. Code § R4-22-302 - Packaging and Inventory
A. An
osteopathic physician shall dispense a controlled substance or
prescription-only drug in a prepackaged or light-resistant container with a
consumer safety cap that complies with standards specified in the official
compendium, as defined at A.R.S. §
32-1901(55),
and state and federal law, unless a patient or the patient's representative
requests a non-safety cap.
B. An
osteopathic physician shall ensure that a dispensed controlled substance or
prescription-only drug is labeled with the following information:
1. The name, address, and telephone number of
the dispensing osteopathic physician;
2. The date the controlled substance or
prescription-only drug is dispensed;
3. The patient's name;
4. The name of the controlled substance or
prescription-only drug, strength, dosage, form, name of manufacturer, quantity
dispensed, directions for use, and any cautionary statement necessary for the
safe and effective used of the controlled substance or prescription-only drug;
and
5. A beyond-use date not to
exceed one year from the date of dispensing or the manufacturer's expiration
date if less than one year.
C. An osteopathic physician shall:
1. Secure all controlled substances in a
locked cabinet or room;
2. Control
access to the locked cabinet or room by a written procedure that includes, at a
minimum:
a. Designation of the persons who
have access to the locked cabinet or room, and
b. Procedures for recording requests for
access to the locked cabinet or room;
3. Make the written procedure required under
subsection (C)(2) available on demand by the Board or its authorized
representative for inspection or copying;
4. Store prescription-only drugs so they are
not accessible to patients; and
5.
Store controlled substances and prescription-only drugs not requiring
refrigeration in an area where the temperature does not exceed 85°
F.
D. An osteopathic
physician shall maintain a dispensing log for all controlled substances and the
prescription-only drug nal-buphine hydrochloride (Nubain) dispensed. The
osteopathic physician shall ensure that the dispensing log includes the
following information on a separate inventory sheet for each controlled
substance or prescription-only drug:
1. Date
the drug is dispensed;
2. Patient's
name;
3. Name of controlled
substance or prescription-only drug, strength, dosage, form, and name of
manufacturer;
4. Number of dosage
units dispensed;
5. Running total
of each controlled substance or prescription-only drug dispensed; and
6. Written signature of the osteopathic
physician next to each entry.
E. An osteopathic physician may use a
computer to maintain the dispensing log required under subsection (D) if the
log is quickly accessible through either on-screen viewing or printing a
copy.
F. This Section does not
apply to a prepackaged manufacturer sample of a controlled substance or
prescription-only drug unless otherwise provided by federal law.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
A. An osteopathic physician shall dispense a controlled substance or prescription-only drug in a prepackaged or light-resistant container with a consumer safety cap that complies with standards specified in the official compendium, as defined at A.R.S. § 32-1901(55), and state and federal law, unless a patient or the patient's representative requests a non-safety cap.
B. An osteopathic physician shall ensure that a dispensed controlled substance or prescription-only drug is labeled with the following information:
1. The name, address, and telephone number of the dispensing osteopathic physician;
2. The date the controlled substance or prescription-only drug is dispensed;
3. The patient's name;
4. The name of the controlled substance or prescription-only drug, strength, dosage, form, name of manufacturer, quantity dispensed, directions for use, and any cautionary statement necessary for the safe and effective used of the controlled substance or prescription-only drug; and
5. A beyond-use date not to exceed one year from the date of dispensing or the manufacturer's expiration date if less than one year.
C. An osteopathic physician shall:
1. Secure all controlled substances in a locked cabinet or room;
2. Control access to the locked cabinet or room by a written procedure that includes, at a minimum:
a. Designation of the persons who have access to the locked cabinet or room, and
b. Procedures for recording requests for access to the locked cabinet or room;
3. Make the written procedure required under subsection (C)(2) available on demand by the Board or its authorized representative for inspection or copying;
4. Store prescription-only drugs so they are not accessible to patients; and
5. Store controlled substances and prescription-only drugs not requiring refrigeration in an area where the temperature does not exceed 85° F.
D. An osteopathic physician shall maintain a dispensing log for all controlled substances and the prescription-only drug nal-buphine hydrochloride (Nubain) dispensed. The osteopathic physician shall ensure that the dispensing log includes the following information on a separate inventory sheet for each controlled substance or prescription-only drug:
1. Date the drug is dispensed;
2. Patient's name;
3. Name of controlled substance or prescription-only drug, strength, dosage, form, and name of manufacturer;
4. Number of dosage units dispensed;
5. Running total of each controlled substance or prescription-only drug dispensed; and
6. Written signature of the osteopathic physician next to each entry.
E. An osteopathic physician may use a computer to maintain the dispensing log required under subsection (D) if the log is quickly accessible through either on-screen viewing or printing a copy.
F. This Section does not apply to a prepackaged manufacturer sample of a controlled substance or prescription-only drug unless otherwise provided by federal law.