Title 902 | Chapter 055 | Regulation 045REG


PROPOSED
This document is not yet current.

902 KAR 55:045.Exempt prescription products.

Section 1.

Exempt Prescription Products.

(1)

Except as provided by subsection (2) of this section, the Cabinet for Health and Family Services exempts prescription products from the licensing, distribution, recordkeeping, and reporting provisions of KRS 218A.150 – 218A.172, 218A.180, 218A.200, and 218A.202 if the products have received approval as exempt prescription products pursuant to 21 C.F.R. 1308.32.

(2)

All products containing butalbital shall:

(a)

Be reported to the Kentucky All-Schedule Prescription Electronic Reporting System in accordance with the requirements established in 902 KAR 55:110; and

(b)

Not be exempt from the licensing, distribution, and recordkeeping provisions of KRS 218A.150 – 218A.172, 218A.180, and 218A.200.

HISTORY: (6 Ky.R. 377; eff. 2-6-1980; Recodified from 901 KAR 1:041, 4-14-1982; Am. 11 Ky.R. 1680; eff. 6-4-1985; 18 Ky.R. 1472; eff. 2-7-1992; 19 Ky.R. 1666; 2251; eff. 3-17-1993; 20 Ky.R. 864; eff. 12-6-1993; 21 Ky.R. 1394; eff. 1-9-1995; 23 Ky.R. 4228; eff. 7-16-1997; 25 Ky.R. 629; 1631; eff. 1-19-1999; 26 Ky.R. 903; 1171; eff. 12-15-1999; 40 Ky.R. 2635; 41 Ky.R. 290; eff. 9-17-2014; Cert. eff. 7-6-2021.)

7-Year Expiration: 7/6/2028

Last Action: 12/15/2021


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