KRS § 315.400 — KY Code / Title XXVI / Chapter 315 / Section 315.400
315.400 Definitions for KRS 315.400 to 315.412
Status: in_force

315.400 Definitions for KRS 315.400 to 315.412.

As used in KRS 315.400 to 315.412:

(1) "Authorized distributor of record" means a wholesale distributor that:

(a) Has established an ongoing relationship with a manufacturer to distribute the

manufacturer's prescription drug. An ongoing relationship exists between a

wholesale distributor and a manufacturer if the wholesale distributor,

including any affiliated group of the wholesale distributor as defined in

Section 1504 of the Internal Revenue Code, has a written agreement for

distribution in effect; and

(b) Is listed on the manufacturer's current list of authorized distributors of record;

(2) "Co-licensed product" means a prescription drug manufactured by two (2) or more

co-licensed partners;

(3) "Counterfeit prescription drug" means a drug which, or the container or labeling of

which, without authorization, bears the trademark, trade name, or other identifying

mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor,

packer, or distributor other than the person or persons who in fact manufactured,

processed, packed, or distributed the drug and which thereby falsely purports or is

represented to be the product of, or to have been packed or distributed by, the other

drug manufacturer, processor, packer, or distributor;

(4) "Dispenser" means:

(a) A retail pharmacy, hospital pharmacy, a group of chain pharmacies under

common ownership and control that do not act as a wholesale distributor, or

any other person authorized by law to dispense or administer prescription

drugs, and the affiliated warehouse distribution centers of such entities under

common ownership and control that do not act as a wholesale distributor; but

(b) Does not include a person who dispenses only products to be used in animals

in accordance with 21 U.S.C. sec. 360b(a)(4) and (5);

(5) "Distribution" or "distribute" means the sale, purchase, trade, delivery, handling,

storage, or receipt of a product, and does not include the dispensing of a product

pursuant to a prescription executed in accordance with Section 503(b)(1) of the

federal Drug Quality and Security Act or the dispensing of a product approved

under Section 512(b) of the federal Drug Quality and Security Act;

(6) "Drop shipment" means a product not physically handled or stored by a wholesale

distributor and that is exempt from Section 582 of the federal Drug Quality and

Security Act, except the notification requirements under clauses (ii), (iii), and (iv) of

subsection (c)(4)(B) of Section 582 of the federal Drug Quality and Security Act,

provided that the manufacturer, repackager, or other wholesale distributor that

distributes the product to the dispenser by means of a drop shipment for the

wholesale distributor includes on the transaction information and transaction history

to the dispenser the contact information of the wholesale distributor and provides

the transaction information, transaction history, and transaction statement directly to

the dispenser. Providing administrative services, including the processing of orders

and payments, shall not by itself be construed as being involved in the handling,

distribution, or storage of a product;

(7) "Emergency medical reasons" includes but is not limited to:

(a) Transfers of a prescription drug between health-care entities or between a

health-care entity and a retail pharmacy to alleviate a temporary shortage of a

prescription drug arising from delays in or interruptions of the regular

distribution schedules;

(b) Sales of drugs for use in the treatment of acutely ill or injured persons to

nearby emergency medical services providers, firefighting organizations, or

licensed health-care practitioners in the same marketing or service area;

(c) The provision of emergency supplies of drugs to nearby nursing homes, home

health agencies, or hospice organizations for emergency use when necessary

drugs cannot be obtained; or

(d) Transfers of prescription drugs by a retail pharmacy to another retail pharmacy

to alleviate a temporary shortage;

(8) "End user" means a patient or consumer that uses a prescription drug as prescribed

by an authorized health-care professional;

(9) "Exclusive distributor" means the wholesale distributor that directly purchased the

product from the manufacturer and is the sole distributor of that manufacturer's

product to a subsequent repackager, wholesale distributor, or dispenser;

(10) "FDA" means the United States Food and Drug Administration and any successor

agency;

(11) "Illegitimate product" means a product for which credible evidence shows that the

product:

(a) Is counterfeit, diverted, or stolen;

(b) Is intentionally adulterated so that the product would result in serious adverse

health consequences or death to humans;

(c) Is the subject of a fraudulent transaction; or

(d) Appears otherwise unfit for distribution so that the product would be

reasonably likely to result in serious adverse health consequences or death to

humans;

(12) "Manufacturer" means the same as defined in KRS 315.010;

(13) "Medical gas wholesaler" means a person licensed to distribute, transfer, wholesale,

deliver, or sell medical gases on drug orders to suppliers or other entities licensed to

use, administer, or distribute medical gas;

(14) "Pharmacy warehouse" means a physical location for prescription drugs that acts as

a central warehouse and performs intracompany sales or transfers of prescription

drugs to a group of pharmacies under common ownership and control;

(15) "Prescription drug" means the same as defined in KRS 315.010;

(16) "Repackager" means a person who owns or operates an establishment that repacks

and relabels a product or package for further sale, or distribution without a further

transaction;

(17) "Reverse distributor" means every person who acts as an agent for pharmacies, drug

wholesalers, manufacturers, or other entities by receiving, taking inventory, and

managing the disposition of outdated or nonsalable drugs;

(18) "Third-party logistics provider" means an entity that contracts with a manufacturer,

wholesale distributor, repackager, or dispenser to provide and coordinate

warehousing or other logistics services on behalf of a manufacturer, wholesale

distributor, repackager, or dispenser, but does not take title to the drug or have

responsibility to direct the sale of the drug. A third-party logistics provider shall be

considered as part of the normal distribution channel;

(19) "Transaction" means the transfer of product between persons in which a change of

ownership occurs, with the following exemptions:

(a) Intracompany distribution of any product between members of an affiliate or

within a manufacturer;

(b) The distribution of a product among hospitals or other health care entities that

are under common control;

(c) The distribution of a product for emergency medical reasons, including a

public health emergency declaration pursuant to Section 319 of the federal

Public Health Service Act, except that a drug shortage not caused by a public

health emergency shall not constitute an emergency medical reason;

(d) The dispensing of a product pursuant to a prescription executed in accordance

with Section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act;

(e) The distribution of product samples by a manufacturer or a licensed wholesale

distributor in accordance with Section 503(d) of the Federal Food, Drug, and

Cosmetic Act;

(f) The distribution of blood or blood components intended for transfusion;

(g) The distribution of minimal quantities of product by a licensed retail

pharmacy to a licensed practitioner for office use;

(h) The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a

drug by a charitable organization described in Section 501(c)(3) of the Internal

Revenue Code of 1986 to a nonprofit affiliate of the organization to the extent

otherwise permitted by law;

(i) The distribution of a product pursuant to the sale or merger of a pharmacy or

pharmacies or a wholesale distributor or wholesale distributors, except that

any records required to be maintained for the product shall be transferred to

the new owner of the pharmacy or pharmacies or wholesale distributor or

wholesale distributors;

(j) The dispensing of a product approved under Section 512(c) of the Federal

Food, Drug, and Cosmetic Act;

(k) Products transferred to or from any facility that is licensed by the Nuclear

Regulatory Commission or by the state pursuant to an agreement with the

commission under Section 274 of the federal Atomic Energy Act, 42 U.S.C.

sec. 2021;

(l) A combination product that is not subject to approval under Section 505 of the

federal Drug Quality and Security Act or licensure under Section 351 of the

federal Public Health Service Act, and that is:

1. A product composed of a device and one (1) or more other regulated

components such as a drug or drug device, a biologic or biologic device,

or a drug and biologic or drug and biologic device that are physically,

chemically, or otherwise combined or mixed and produced as a single

entity;

2. Two (2) or more separate products packaged together in a single

package or as a unit and composed of a drug and device or device and

biological product; or

3. Two (2) or more finished medical devices plus one (1) or more drug or

biological products that are packaged together in what is referred to as a

medical convenience kit as described in paragraph (m) of this

subsection;

(m) The distribution of a medical convenience kit or collection of finished medical

devices which may include a product or biological product, assembled in kit

form strictly for the convenience of the purchaser or user, if:

1. The medical convenience kit is assembled in an establishment that is

registered with the federal Food and Drug Administration as a device

manufacturer in accordance with Section 510(b)(2) of the Federal Food,

Drug, and Cosmetic Act;

2. The medical convenience kit does not contain a controlled substance

that appears in a schedule contained in the federal Comprehensive Drug

Abuse Prevention and Control Act of 1970;

3. In the case of a medical convenience kit that includes a product, the

person that manufacturers the kit:

a. Purchased the product directly from the pharmaceutical

manufacturer or from a wholesale distributor that purchased the

product directly from the pharmaceutical manufacturer; and

b. Does not alter the primary container or label of the product as

purchased from the manufacturer or wholesale distributor; and

4. In the case of a medical convenience kit that includes a product, the

product is:

a. An intravenous solution intended for the replenishment of fluids

and electrolytes;

b. A product intended to maintain the equilibrium of water and

minerals in the body;

c. A product intended for irrigation or reconstitution;

d. An anesthetic;

e. An anticoagulant;

f. A vasopressor; or

g. A sympathomimetic;

(n) The distribution of an intravenous product that, by its formulation, is intended

for the replenishment of fluids and electrolytes such as sodium, chloride, and

potassium, or calories such as dextrose and amino acids;

(o) The distribution of an intravenous product used to maintain the equilibrium of

water and minerals in the body, such as dialysis solutions;

(p) The distribution of a product that is intended for irrigation, or sterile water,

whether intended for such purposes or for injection;

(q) The distribution of a medical gas as defined in Section 575 of the Federal

Food, Drug, and Cosmetic Act; or

(r) The distribution or sale of any licensed product under Section 351 of the

federal Public Health Service Act that meets the definition of a device under

Section 201(h) of the Federal Food, Drug, and Cosmetic Act;

(20) "Wholesale distribution" means the distribution of a prescription drug to persons

other than an end user or to the end user pursuant to KRS 315.0351(2), but does not

include:

(a) Intracompany sales or transfers;

(b) The sale, purchase, distribution, trade, or transfer of a prescription drug for

emergency medical reasons;

(c) The distribution of prescription drug samples by a manufacturer or authorized

distributor;

(d) Drug returns or transfers to the original manufacturer, original wholesale

distributor, or transfers to a reverse distributor or third-party returns processor;

(e) The sale, purchase, or trade of a drug pursuant to a prescription;

(f) The delivery of a prescription drug by a common carrier;

(g) The purchase or acquisition by a health-care entity or pharmacy that is a

member of a group purchasing organization of a drug for its own use from the

group purchasing organization, or health-care entities or pharmacies that are

members of the group organization;

(h) The sale, purchase, distribution, trade, or transfer of a drug by a charitable

health-care entity to a nonprofit affiliate of the organization as otherwise

permitted by law;

(i) The sale, transfer, merger, or consolidation of all or part of the business of a

pharmacy with another pharmacy or pharmacies; or

(j) The distribution of a prescription drug to a health-care practitioner or to

another pharmacy if the total number of units transferred during a twelve (12)

month period does not exceed five percent (5%) of the total number of all

units dispensed by the pharmacy during the immediate twelve (12) month

period; and

(21) "Wholesale distributor" or "virtual wholesale distributer" means a person other than

a manufacturer, a manufacturer's co-licensed partner, a third-party logistics

provider, or repackager engaged in wholesale distribution as defined by 21 U.S.C.

sec. 353(e)(4) as amended by the federal Drug Supply Chain Security Act.