Ariz. Admin. Code § 4-23-1003

Current through Register Vol. 30, No. 24, June 14, 2024

Section R4-23-1003 - Records and Order Forms

A. Records.

1. If the pharmacist-in-charge of a pharmacy is replaced by another pharmacist-in-charge, the new pharmacist-in-charge shall complete an inventory of all controlled substances in the pharmacy within 10 days of assuming the responsibility. This inventory and any other required controlled substance inventory shall:

a. Include an exact count of all Schedule II controlled substances;

b. Include an exact count of all Schedule III through Schedule V controlled substances or an estimated count if the stock container contains fewer than 1001 units;

c. Indicate the date the inventory is taken and whether the inventory is taken before opening of business or after close of business for the pharmacy;

d. Be signed by:

i. The pharmacist-in-charge; or

ii. For other required inventories, the pharmacist who does the inventory;

e. Be kept separately from all other records; and

f. Be available in the pharmacy for inspection by the Board or its designee for not less than three years.

2. A loss of a controlled substance shall be reported:

a. Within 10 days of discovery;

b. On a DEA form 106;

c. By the pharmacist-in-charge of a pharmacy or a manufacturer;

d. By the permittee or designated representative of a full-service wholesaler; and

e. To the federal Drug Enforcement Administration (DEA), the Narcotic Division of the Department of Public Safety (DPS), and the Board of Pharmacy. A copy of the DEA form 106 shall be kept on file by the pharmacy permittee. The DEA form 106 shall state whether the police investigated the loss.

3. Every person manufacturing any controlled substance, including repackaging or relabeling, shall record and retain for not less than three years the manufacturing, repackaging, or relabeling date for each controlled substance.

4. Every person receiving, selling, delivering, or disposing of any controlled substance shall record and retain for not less than three years the following information:

a. The name, strength, dosage form, and quantity of each controlled substance received, sold, delivered, or disposed;

b. The name, address, and DEA registration number of the person from whom each controlled substance is received;

c. The name, address, and DEA registration number of the person to whom each controlled substance is sold or delivered or who disposes of each controlled substance; and

d. The date of each transaction.

5. A full-service drug wholesale permittee or the designated representative shall complete an inventory of all controlled substances in the manner prescribed in subsection (A)(1). The permittee or designated representative shall conduct this inventory:

a. On May 1 of each year or as directed by the Board; and

b. If there is a change of ownership, or discontinuance of business, or within 10 days of a change of a designated representative.

6. A drug manufacturer permittee or the pharmacist-in-charge shall complete an inventory of all controlled substances in the manner prescribed in subsection (A)(1). The permittee or pharmacist-in-charge shall conduct this inventory:

a. On May 1 of each year or as directed by the Board; and

b. If there is a change of ownership, or discontinuance of business, or within 10 days of a change of a pharmacist-in-charge.

B. Order form. For purposes of A.R.S. § 36-2524, "Order Form" means DEA Form 222c.

Ariz. Admin. Code § R4-23-1003

Adopted effective August 2, 1982 (Supp. 82-4). Amended effective November 1, 1993 (Supp. 93-4). Amended effective April 1, 1995; filed January 31, 1995 (Supp. 95-1). Amended by final rulemaking at 6 A.A.R. 3177, effective August 3, 2000 (Supp. 00-3). Amended by final rulemaking at 12 A.A.R. 1912, effective July 1, 2006 (Supp. 06-2). Amended by final rulemaking at 14 A.A.R. 3670, effective November 8, 2008 (Supp. 08-3).