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AN ACT relating to purchase limits for pseudoephedrine. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
ď˘Section 1. KRS 218A.1446 is amended to read as follows: 3
(1) Any compound, mixture, or preparation containing any detectable quantity of 4
ephedrine, pseudoephedrine, or phenylpropanolamine, their salts or optical isomers, 5
or salts of optical isomers shall be dispensed, sold, or distributed only by a 6
registered pharmacist, a pharmacy intern, or a pharmacy technician. 7
(2) Any person purchasing, receiving, or otherwise acquiring any nonprescription 8
compound, mixture, or preparation containing any detectable quantity of ephedrine, 9
pseudoephedrine, or phenylpropanolamine, their salts or optical isomers, or salts of 10
optical isomers shall: 11
(a) Produce a government-issued photo identification showing the date of birth of 12
the person; and 13
(b) Sign a log or record showing the: 14
1. Date of the transaction; 15
2. Name, date of birth, and address of the person making the purchase; and 16
3. The amount and name of the compound, mixture, or preparation. 17
Only an electronic logging or recordkeeping mechanism approved by the Office of 18
Drug Control Policy may be utilized to meet the requirements of this subsection. No 19
pharmacy may dispense or sell any compound, mixture, or preparation containing 20
any detectable quantity of ephedrine, pseudoephedrine, or phenylpropanolamine, 21
their salts or optical isomers, or salts of optical isomers unless the electronic 22
logging or recordkeeping mechanism required by this section is provided at no cost 23
to the pharmacy. 24
(3) An electronic log or record, as described in subsection (2) of this section, shall be 25
kept of each day's transactions. The registered pharmacist, a pharmacy intern, or a 26
pharmacy technician shall initial the entry of each sale in the log, evidencing 27 UNOFFICIAL COPY 24 RS HB 386/GA
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completion of each transaction. The log shall be: 1
(a) Kept for a period of two (2) years; and 2
(b) Subject to random and warrantless inspection by city, county, or state law 3
enforcement officers. 4
(4) (a) Intentional failure of a registered pharmacist, a pharmacy intern, or a 5
pharmacy technician to make an accurate entry of a sale of a product or failure 6
to maintain the log records as required by this section may subject him or her 7
to a fine of not more than one thousand dollars ($1,000) for each violation and 8
may be evidence of a violation of KRS 218A.1438. 9
(b) If evidence exists that the pharmacist's, the pharmacy intern's, or the 10
pharmacist technician's employer fails, neglects, or encourages incorrect entry 11
of information by improper training, lack of supervision or oversight of the 12
maintenance of logs, or other action or inaction, the employer shall also face 13
liability under this section and any other applicable section of this chapter. 14
(c) It shall be a defense to a violation of this section that the person proves that 15
circumstances beyond the control of the registered pharmacist, pharmacy 16
intern, or pharmacy technician delayed or prevented the making of the record 17
or retention of the record as required by this section. Examples of 18
circumstances beyond the control of the registered pharmacist, pharmacy 19
intern, or pharmacy technician include but are not limited to: 20
1. Fire, natural or manmade disaster, loss of power, and similar events; 21
2. Robbery, burglary, shoplifting, or other criminal act by a person on the 22
premises; 23
3. A medical emergency suffered by the registered pharmacist, pharmacy 24
intern, or pharmacy technician, another employee of the establishment, a 25
customer, or any other person on the premises; or 26
4. Some other circumstance that establishes that an omission was 27 UNOFFICIAL COPY 24 RS HB 386/GA
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inadvertent. 1
(5) No person shall purchase, receive, or otherwise acquire any product, mixture, or 2
preparation or combinations of products, mixtures, or preparations containing more 3
than seven and one-fifth (7.2) grams of ephedrine, pseudoephedrine, or 4
phenylpropanolamine, their salts or optical isomers, or salts of optical isomers 5
within any thirty (30) day period[ or twenty-four (24) grams within any one (1) year 6
period], provided that this limit[either of these limits] shall not apply to any 7
quantity of product, mixture or preparation dispensed pursuant to a valid 8
prescription.[ In addition to the thirty (30) day and the one (1) year restrictions, no 9
person shall purchase, receive, or otherwise acquire more than three (3) packages of 10
any product, mixture, or preparation containing ephedrine, pseudoephedrine, or 11
phenylpropanolamine, their salts or optical isomers, or salts of optical isomers 12
during each transaction.] 13
(6) A person under eighteen (18) years of age shall not purchase or attempt to purchase 14
any quantity of a nonprescription ephedrine, p seudoephedrine, or 15
phenylpropanolamine product as described in subsection (1) of this section. No 16
person shall aid or assist a person under eighteen (18) years of age in purchasing 17
any quantity of a nonprescription ephedrine, pseudoephedrine, or 18
phenylpropanolamine product as described in subsection (1) of this section. 19
(7) The requirements of this section shall not apply to any compounds, mixtures, or 20
preparation containing ephedrine, pseudoephedrine, or phenylpropanolamine, their 21
salts or optical isomers, or salts of optical isomers which are in liquid, liquid 22
capsule, or gel capsule form or to any compounds, mixtures, or preparations 23
containing ephedrine, pseudoephedrine, or phenylpropanolamine, or their salts or 24
optical isomers which are deemed to be not subject to abuse upon joint review and 25
agreement of the Office of Drug Control Policy, the Board of Pharmacy, and the 26
Cabinet for Health and Family Services. 27 UNOFFICIAL COPY 24 RS HB 386/GA
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(8) The provisions of this section shall not apply to a: 1
(a) Licensed manufacturer manufacturing and lawfully distributing a product in 2
the channels of commerce; 3
(b) Wholesaler lawfully distributing a product in the channels of commerce; 4
(c) Pharmacy with a valid permit from the Kentucky Board of Pharmacy; 5
(d) Health care facility licensed pursuant to KRS Chapter 216B; 6
(e) Licensed long-term care facility; 7
(f) Government-operated health department; 8
(g) Physician's office; 9
(h) Publicly operated prison, jail, or juvenile correctional facility, or a private 10
adult or juvenile correctional facility under contract with the Commonwealth; 11
(i) Public or private educational institution maintaining a health care program; or 12
(j) Government-operated or industrial medical facility serving its own 13
employees. 14
(9) The provisions of this section shall supersede and preempt all local laws, 15
ordinances, and regulations pertaining to the sale of any compounds, mixtures, or 16
preparation containing ephedrine, pseudoephedrine, phenylpropanolamine, their 17
salts or optical isomers, or salts of optical isomers. 18
(10) To be approved for use under this section, a logging or recordkeeping system shall: 19
(a) Be designed to block the dispensing of any compound, mixture, or preparation 20
containing ephedrine, pseudoephedrine, phenylpropanolamine, their salts or 21
optical isomers, or salts of optical isomers, where the dispensing would 22
exceed the quantity limitations established in this section or would be 23
prohibited under KRS 218A.1440; and 24
(b) Allow unimpeded access by the Office of Drug Control Policy to any data 25
stored in the system for statistical analysis purposes. 26
(11) The Office of Drug Control Policy shall prepare and submit to the Legislative 27 UNOFFICIAL COPY 24 RS HB 386/GA
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Research Commission an annual statistical report on the sale of compounds, 1
mixtures, or preparations containing ephedrine, pseudoephedrine, 2
phenylpropanolamine, their salts or optical isomers, or salts of optical isomers, 3
including state and county sale amounts and numbers of individual purchasers. 4