§ 59-353.18 — Sale, manufacturing or packaging of dangerous drugs,

Oklahoma § 59-353.18

• Jurisdiction: Oklahoma
• Title 59: Professions And Occupations

Text

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 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 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 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, 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.

Legislative History

Added by Laws 1961, p. 450, § 18, emerg. eff. May 22, 1961. Amended by Laws 1970, c. 56, § 2, emerg. eff. March 16, 1970; Laws 1973, c. 115, § 1, emerg. eff. May 4, 1973; Laws 1976, c. 83, § 4, emerg. eff. May 3, 1976; Laws 1981, c. 75, § 3, emerg. eff. April 16, 1981; Laws 1982, c. 172, § 4, emerg. eff. April 16, 1982; Laws 1987, c. 20, § 2, eff. Nov. 1, 1987; Laws 1988, c. 231, § 1, emerg. eff. June 22, 1988; Laws 1990, c. 120, § 3; Laws 1993, c. 199, § 14, emerg. eff. May 24, 1993; Laws 2004, c. 523, § 20, emerg. eff. June 9, 2004; Laws 2005, c. 285, § 2, eff. Nov. 1, 2005; Laws 2009, c. 321, § 15, eff. Nov. 1, 2009; Laws 2015, c. 230, § 11, eff. Nov. 1, 2015; Laws 2016, c. 285, § 4, eff. Nov. 1, 2016; Laws 2021, c. 422, § 1, eff. Nov. 1, 2021. NOTE: Laws 2005, c. 357, § 1 repealed by Laws 2006, c. 16, § 40, emerg. eff. March 29, 2006.