Kan. Admin. Regs. § 68-20-16 - Records and inventories of registrants

(a) Except as provided in this regulation, each registrant shall keep records and maintain inventories in conformance with the recordkeeping and inventory requirements of 21 C.F.R. 1304.04(a)(2), (a)(3), (f), (g), (h)(1), (h) (2), (h)(3), and (h)(4), as in effect on February 1, 2022, which are hereby adopted by reference. Except as otherwise provided in this regulation, the registrant shall maintain executed order forms and controlled substance inventories at the registered facility and keep the records on file for at least five years.

(b) After the initial inventory is taken, the registrant shall take a subsequent inventory of all controlled substances and drugs of concern on hand at least every year but no later than 375 days after the date of the previous inventory. All controlled substances and drugs of concern shall be inventoried on the same calendar date.

(c) Each required inventory of schedule II controlled substances and nonliquid dosage forms of other controlled substances and drugs of concern shall be taken by exact count.

(d) Each registrant handling schedule V controlled substances and drugs of concern shall be subjected to the same inventory and recordkeeping requirements specified in subsections (a) and (b).

(e) Each inventory of controlled substances shall be maintained in legible, hard-copy format and shall include the following:

(1) The date the inventory was conducted;

(2) the name, license or registration number, and signature of each individual participating in the inventory; and

(3) documentation of whether the inventory was taken before the opening of business or after the close of business. If the pharmacy is open 24 hours per day and does not close, the time that the count was taken shall be documented.

Notes

Kan. Admin. Regs. § 68-20-16

Authorized by K.S.A. 65-4102 and K.S.A. 65-4121; implementing K.S.A. 65-4121; effective, E-72-24, Aug. 25, 1972; effective Jan. 1, 1973; amended May 1, 1989; amended July 31, 1998; amended Dec. 27, 1999; amended Nov. 13, 2009; amended 6/2/2023.