Tenn. Comp. R. & Regs. 0940-05-36-.09

Current through December 10, 2024

Section 0940-05-36-.09 - INVENTORY

(1) Each OBOT Plus shall be required to procure all buprenorphine containing products from a wholesaler/distributor licensed by the Tennessee Board of Pharmacy pursuant to Rule 1140-09.

(2) Each OBOT Plus shall maintain an inventory of buprenorphine products. Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and shall be maintained in written, typewritten, or printed form at the physical location.

(a) Each licensee shall be required to take an initial inventory of all buprenorphine products, in accordance with Rule 0940-05-36-.09(3), prior to dispensing any of these products to patients.

(b) After the initial inventory is taken, the OBOT Plus facility shall be required to maintain a perpetual inventory of buprenorphine products.

(3) Each person authorized to dispense buprenorphine products shall include the following information in the inventory documentation pursuant to 21 C.F.R. Part 1304.11(1)(e)(iii) and (iv):

(a) The name and address of the OBOT Plus facility;

(b) The following information for each buprenorphine product in finished form:

1. The name of the substance;

2. Each finished form of the substance (e.g., 8/2 mg films);

3. The number of commercial containers of each finished form (e.g. four 30-film boxes); and

4. The exact quantity of the finished form on hand.

(c) The date of inventory; and

(d) The time the inventory was taken.

(4) The Facility Director or a designated clinical staff member shall immediately return or destroy all outdated, defective, or deteriorated prescription drugs and devices and related materials; except that the destruction of controlled substances listed in any schedule shall be witnessed by a second healthcare professional and documented.

(5) For each damaged or defective controlled substance awaiting disposal, the inventories shall include:

(a) The name of the substance;

(b) The total quantity of the substance to the nearest metric unit weight or the total number of units of finished form; and

(c) The reason for the substance being maintained by the OBOT Plus facility.

(6) If an OBOT Plus destroys buprenorphine products they must be destroyed onsite or via a reverse distributor.

(a) For each buprenorphine product destroyed onsite, the facility shall keep a record of the following:

1. The name of the substance;

2. The strength of the substance;

3. The dosage form of the substance;

4. The total quantity destroyed;

5. Method of destruction;

6. Date and time of the destruction;

7. The signature of the person destroying the substance; and

8. The signature of at least one person, other than the person destroying the substance, who witnessed the destruction of the substance.

(7) Each OBOT Plus shall maintain documentation of a current employment or contractual relationship with a consultant pharmacist.

(a) If an OBOT Plus dispenses buprenorphine to less than 100 unique patients a month, the pharmacist-in-charge shall perform a quarterly inventory review of the OBOT Plus's invoices, perpetual inventory, and documentation of dispensed medications.

(b) If an OBOT Plus dispenses buprenorphine to 100 or more unique patients a month, the pharmacist-in-charge shall perform a monthly review of the OBOT Plus's invoices, perpetual inventory, and documentation of dispensed medications and review the inventory for discrepancies.

1. If a discrepancy is found, an OBOT Plus shall report the discrepancy to the Department immediately upon discovery. The OBOT Plus shall also report to the DEA any discrepancies as appropriate.

2. Within 14 calendar days of discovery of a discrepancy, the OBOT Plus shall submit to the Department a root cause analysis examining the cause of the discrepancy and a plan to prevent such discrepancies in the future.

3. Part of the plan may include an increase in inventory review by the pharmacist-in-charge.

Tenn. Comp. R. & Regs. 0940-05-36-.09

Original rules filed March 29, 2019; effective 6/27/2019.

Authority: T.C.A. §§ 4-3-1601, 4-4-103, 33-1-302, 33-1-305, 33-1-309, 33-2-301, 33-2-302, 33-2-402, 33-2-403, 33-2-404, 33-2-407, and Chapter 978 of the Public Acts of 2018.