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