SB 27 — AN ACT relating to pharmaceutical manufacturers.

A "contact hour" means fifty (50) continuous minutes without a break period;

(9) "Dispense" or "dispensing" means to deliver one (1) or more doses of a prescription drug in a suitable container, appropriately labeled for subsequent administration to or use by a patient or other individual entitled to receive the prescription drug;

(10) "Drug" means any of the following:

(a) Articles recognized as drugs or drug products in any official compendium or supplement thereto;

(b) Articles, other than food, intended to affect the structure or function of the body of man or other animals;

(c) Articles, including radioactive substances, intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals;

or (d) Articles intended for use as a component of any articles specified in paragraphs (a) to (c) of this subsection;

(11) "Drug regimen review" means retrospective, concurrent, and prospective review by a pharmacist of a patient's drug-related history, including but not limited to the following areas:

(a) Evaluation of prescription drug orders and patient records for:

1.

Known allergies;

2.

Rational therapy contraindications;

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Appropriate dose and route of administration;

4.

Appropriate directions for use;

or 5.

Duplicative therapies;

(b) Evaluation of prescription drug orders and patient records for drug-drug, drug-food, drug-disease, and drug-clinical laboratory interactions;

(c) Evaluation of prescription drug orders and patient records for adverse drug reactions;

or (d) Evaluation of prescription drug orders and patient records for proper utilization and optimal therapeutic outcomes;

(12) "Immediate supervision" means under the physical and visual supervision of a pharmacist;

(13) "Manufacturer" or "virtual manufacturer" of a product means:

(a) A person that holds an application approved under 21 U.S.C.

sec.

355 or a license issued under 42 U.S.C.

sec.

262 for such product, or if such product is not the subject of an approved application or license, the person who manufactured the product;

(b) A co-licensed partner of the person described in paragraph (a) of this subsection that obtains the product directly from a person described in this paragraph or paragraph (a) of this subsection;

(c) An affiliate of a person described in paragraph (a) or (b) of this subsection who receives the product directly from a person described in this paragraph or in paragraph (a) or (b) of this subsection;

or (d) A pharmacist compounding drugs intended for human use without a valid prescription drug order[Any person, except a pharmacist compounding in the normal course of professional practice];

(14) "Medical order" means a lawful order of a specifically identified practitioner for a specifically identified patient for the patient's health care needs.

"Medical order" Page 5 of 8 SB002710.100 - 1077 - XXXX 3/11/2024 3:55 PM GA UNOFFICIAL COPY 24 RS SB 27/GA may or may not include a prescription drug order;

(15) "Nonprescription drugs" means nonnarcotic medicines or drugs which may be sold without a prescription and are prepackaged and labeled for use by the consumer in accordance with the requirements of the statutes and regulations of this state and the federal government;

(16) "Outsourcing facility" means a facility at one (1) geographic location or address that:

(a) Is engaged in the compounding of human sterile drugs without a patient- specific prescription;

(b) Has registered as an outsourcing facility with the secretary of the United States Department of Health and Human Services, Food and Drug Administration;

and (c) Complies with all applicable state and federal requirements;

(17) "Pharmacist" means a natural person licensed by this state to engage in the practice of the profession of pharmacy;

(18) "Pharmacist intern" means a natural person who is:

(a) Currently certified by the board to engage in the practice of pharmacy under the direction of a licensed pharmacist and who satisfactorily progresses toward meeting the requirements for licensure as a pharmacist;

(b) A graduate of an approved college or school of pharmacy or a graduate who has established educational equivalency by obtaining a Foreign Pharmacy Graduate Examination Committee (FPGEC) certificate, who is currently licensed by the board for the purpose of obtaining practical experience as a requirement for licensure as a pharmacist;

(c) A qualified applicant awaiting examination for licensure as a pharmacist or the results of an examination for licensure as a pharmacist;

or (d) An individual participating in a residency or fellowship program approved by Page 6 of 8 SB002710.100 - 1077 - XXXX 3/11/2024 3:55 PM GA UNOFFICIAL COPY 24 RS SB 27/GA the board for internship credit;

(19) "Pharmacy" means every place where:

(a) Drugs are dispensed under the direction of a pharmacist;

(b) Prescription drug orders are compounded under the direction of a pharmacist;

or (c) A registered pharmacist maintains patient records and other information for the purpose of engaging in the practice of pharmacy, whether or not prescription drug orders are being dispensed;

(20) "Pharmacy-related primary care" means the pharmacists' activities in patient education, health promotion, and assistance in the selection and use of over-the- counter drugs and appliances for the treatment of common diseases and injuries, as well as those other activities falling within their statutory scope of practice;

(21) "Pharmacy technician" means a natural person who works under the immediate supervision, or general supervision if otherwise provided for by statute or administrative regulation, of a pharmacist for the purpose of assisting a pharmacist with the practice of pharmacy;

(22) "Practice of pharmacy" means interpretation, evaluation, and implementation of medical orders and prescription drug orders;

responsibility for dispensing prescription drug orders, including radioactive substances;

participation in drug and drug-related device selection;

administration of medications or biologics in the course of dispensing or maintaining a prescription drug order;

the administration of adult immunizations pursuant to prescriber-approved protocols;

the administration of immunizations to individuals nine (9) to seventeen (17) years of age pursuant to prescriber-approved protocols with the consent of a parent or guardian;

the administration of immunizations to a child as defined in KRS 214.032, pursuant to protocols as authorized by KRS 315.500;

drug evaluation, utilization, or regimen review;

maintenance of patient pharmacy records;

and provision of patient Page 7 of 8 SB002710.100 - 1077 - XXXX 3/11/2024 3:55 PM GA UNOFFICIAL COPY 24 RS SB 27/GA counseling and those professional acts, professional decisions, or professional services necessary to maintain and manage all areas of a patient's pharmacy-related care, including pharmacy-related primary care as defined in this section;

(23) "Practitioner" has the same meaning given in KRS 217.015(35);

(24) "Prescription drug" means a drug which:

(a) Under federal law is required to be labeled with either of the following statements:

1.

"Caution:

Federal law prohibits dispensing without prescription";

2.

"Caution:

Federal law restricts this drug to use by, or on the order of, a licensed veterinarian";

3.

"Rx Only";

or 4.

"Rx";

or (b) Is required by any applicable federal or state law or administrative regulation to be dispensed only pursuant to a prescription drug order or is restricted to use by practitioners;

(25) "Prescription drug order" means an original or new order from a practitioner for drugs, drug-related devices or treatment for a human or animal, including orders issued through collaborative care agreements or protocols authorized by the board.

Lawful prescriptions result from a valid practitioner-patient relationship, are intended to address a legitimate medical need, and fall within the prescribing practitioner's scope of professional practice;

(26) "Society" means the Kentucky Society of Health-Systems Pharmacists;

(27) "Supervision" means the presence of a pharmacist on the premises to which a pharmacy permit is issued, who is responsible, in whole or in part, for the professional activities occurring in the pharmacy;

and (28) "Wholesaler" means any person who legally buys drugs for resale or distribution to persons other than patients or consumers.

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