Okla. Stat. tit. 59, § 59-353.18

medicines, chemicals or poisons – Qualifications for licensure -

Violations – Penalties.

A. 1. It shall be unlawful for any person, including, but not

limited to, Internet, website or online pharmacies, to sell at

retail or to offer for sale, dangerous drugs, medicines, chemicals

or poisons for the treatment of disease, excluding agricultural

chemicals and drugs, or to accept prescriptions for same, without

first procuring a license from the State Board of Pharmacy. This

licensure requirement applies whether such sale, offer for sale or

acceptance of prescriptions occurs in this state, or such sale,

offer for sale, or acceptance of prescriptions occurs out of state

and the dangerous drug, medicine, chemical or poison is to be

delivered, distributed or dispensed to patients or customers in this

state. This licensure requirement shall not apply to the

distribution or dispensing of dialysate or peritoneal dialysis

devices to patients with end-stage renal disease (ESRD) consistent

with subsection F of this section.

2. A pharmacy license shall be issued to such person as the

Board shall deem qualified upon evidence satisfactory to the Board

that:

a. the place for which the license is sought will be

conducted in full compliance with the law and the

rules of the Board,

b. the location and physical characteristics of the place

are reasonably consistent with the maintenance of

professional surroundings and constitute no known

danger to the public health and safety,

c. the place will be under the management and control of

a licensed pharmacist or pharmacist-in-charge who

shall be licensed as a pharmacist in Oklahoma, and

d. a licensed pharmacist shall be present and on duty at

all business hours; provided, however, the provisions

of this subparagraph shall not apply to hospital drug

rooms.

3. a. An application for an initial or renewal license

issued pursuant to the provisions of this subsection

shall:

(1) be submitted to the Board in writing,

(2) contain the name or names of persons owning the

pharmacy, and

(3) provide other such information deemed relevant by

the Board.

b. An application for an initial or renewal license shall

be accompanied by a licensing fee not to exceed Three

Hundred Dollars ($300.00) for each period of one (1)

year. Prior to opening for business, all applicants

Oklahoma Statutes - Title 59. Professions and Occupations Page 306

for an initial license or permit shall be inspected.

An initial licensure applicant shall pay an inspection

fee not to exceed Two Hundred Dollars ($200.00);

provided, however, that no charge shall be made for

the licensing of any Federal Veterans Hospital in the

State of Oklahoma. Non-resident pharmacies shall

reimburse the Board for any actual expenses incurred

for inspections.

c. A license issued pursuant to the provisions of this

subsection shall be valid for a period set by the

Board and shall contain the name of the licensee and

the address of the place at which such business shall

be conducted.

4. A retail pharmacy that prepares sterile drugs shall obtain a

pharmacy license, and shall also obtain a sterile compounding permit

at a fee set by the Board, not to exceed Seventy-five Dollars

($75.00). Such pharmacy shall meet requirements set by the Board by

rule for sterile compounding permits.

5. An outsourcing facility desiring to dispense prescriptions

to patients must additionally license and meet the requirements of a

pharmacy.

B. 1. It shall be unlawful for any person to manufacture,

repackage, distribute, outsource, warehouse or be a third-party

logistics provider of any dangerous drugs, medicines, medical gases,

chemicals, or poisons for the treatment of disease, excluding

agricultural chemicals, without first procuring a license from the

Board. It shall be unlawful to sell or offer for sale at retail or

wholesale dangerous drugs, medicines, medical gases, chemicals or
repackage, distribute, outsource, warehouse or be a third-party

logistics provider of any dangerous drugs, medicines, medical gases,

chemicals, or poisons for the treatment of disease, excluding

agricultural chemicals, without first procuring a license from the

Board. It shall be unlawful to sell or offer for sale at retail or

wholesale dangerous drugs, medicines, medical gases, chemicals or

poisons without first procuring a license from the Board. This

licensure requirement shall apply when the manufacturing,

repackaging, distributing, outsourcing, warehousing, or provision of

third-party logistics occurs in this state or out of state for

delivery, distribution, or dispensing to patients or customers in

this state.

2. A license shall be issued to such person as the Board shall

deem qualified upon satisfactory evidence to the Board that:

a. the place for which the license is sought will be

conducted in full compliance with the laws of this

state and the administrative rules of the Board,

b. the location and physical characteristics of the place

of business are reasonably consistent with the

maintenance of professional surroundings and

constitute no known danger to public health and

safety,

c. the place shall be under the management and control of

such persons as may be approved by the Board after a

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review and determination of the persons'

qualifications, and

d. an outsourcing facility shall designate in writing on

a Board-approved form a person to serve as the

pharmacist-in-charge who is a pharmacist licensed by

the Board.

3. a. An application for an initial or renewal license

issued pursuant to the provisions of this subsection

shall:

(1) be submitted to the Board in writing,

(2) contain the name or names of the owners or the

applicants, and

(3) provide such other information deemed relevant by

the Board.

b. An application for an initial or renewal license shall

be accompanied by a licensing fee not to exceed Three

Hundred Dollars ($300.00) for each period of one (1)

year. Prior to opening for business, all applicants

for initial or renewal license shall be inspected. An

initial licensure applicant shall pay an inspection

fee not to exceed Two Hundred Dollars ($200.00). Non-

resident applicants shall reimburse the Board for any

actual expenses incurred for inspections.

c. A license issued pursuant to the provisions of this

subsection shall contain the name of the licensee and

the address of the place at which such business shall

be conducted and shall be valid for a period of time

set by the Board.

C. A licensee or permit holder who, pursuant to the provisions

of this section, fails to complete an application for a renewal

license or permit by the fifteenth day after the expiration of the

license or permit shall pay a late fee to be fixed by the Board.

D. 1. The Board shall promulgate rules regarding the issuance

and renewal of licenses and permits pursuant to the Oklahoma

Pharmacy Act which shall include, but need not be limited to,

provisions for new or renewal application requirements for its

licensees and permit holders. Requirements for new and renewal

applications may include, but need not be limited to, the following:

a. type of ownership, whether individual, partnership,

limited liability company or corporation,

b. names and addresses of principal owners or officers

and their Social Security numbers, including

applicant's full name, all trade or business names

used, full business address, telephone numbers, and

email addresses,

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c. names of designated representatives and facility

managers and their Social Security numbers and dates

of birth,

d. evidence of a criminal background check and

fingerprinting of the applicant, if a person, and all

of the applicant's designated representatives and

facility managers,
telephone numbers, and

email addresses,

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c. names of designated representatives and facility

managers and their Social Security numbers and dates

of birth,

d. evidence of a criminal background check and

fingerprinting of the applicant, if a person, and all

of the applicant's designated representatives and

facility managers,

e. a copy of the license from the applicant's home state,

and if applicable, from the federal government,

f. bond requirements, and

g. any other information deemed by the Board to be

necessary to protect the public health and safety.

2. The Board shall be authorized to use an outside agency, such

as the National Association of Boards of Pharmacy (NABP) or the

Verified-Accredited Wholesale Distributors (VAWD), to accredit

wholesale distributors and repackagers.

E. The Oklahoma Pharmacy Act shall not be construed to prevent

the sale of nonprescription drugs in original manufacturer packages

by any merchant or dealer.

F. The Oklahoma Pharmacy Act shall not be construed to apply to

a facility engaged in the distribution or dispensing to patients of

dialysate or peritoneal dialysis devices necessary to perform home

peritoneal dialysis, provided the following criteria are met:

1. The dialysate is comprised of dextrose or icodextrin;

2. The dialysate or peritoneal dialysis devices are approved or

cleared by the United States Food and Drug Administration;

3. The dialysate or peritoneal dialysis devices are lawfully

held by a manufacturer, or the manufacturer's agent, who is properly

licensed by the Board as a manufacturer, wholesaler or distributor;

4. The dialysate or peritoneal dialysis devices are held and

delivered in their original, sealed packaging from the manufacturing

facility;

5. The dialysate or peritoneal dialysis devices are delivered

only upon receipt of a physician's prescription by a licensed

pharmacy, and the transmittal of an order from the licensed pharmacy

to the manufacturer or the manufacturer's agent; and

6. The manufacturer or agent of the manufacturer delivers the

dialysate or peritoneal dialysis devices directly to:

a. a patient with ESRD or the patient's designee for the

patient's self-administration of the dialysis therapy,

or

b. a health care provider or institution for

administration or delivery of the dialysis therapy to

the patient with ESRD.