§ 59-353.18. Sale, manufacturing or packaging of dangerous drugs, medicines, chemicals or poisons – Qualifications for licensure - Violations - Penalties.  


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  • A.  1.  It shall be unlawful for any person, including, but not limited to, Internet, website or online pharmacies, to engage in selling at retail, or offering 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 applies whether such sale, offer for sale or acceptance of prescriptions occurs from this state, or such sale, offer for sale, or acceptance of prescription occurs and is to be delivered, distributed or dispensed to patients or customers in this state.  The provisions of this subsection shall not apply to medical gas suppliers or medical gas distributors regulated pursuant to the provisions of subsection B of this section.

    2.  A 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, appointments 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, and

    d.a licensed pharmacist will be present and on duty at all hours the pharmacy is open for business; provided, however, the provisions of this subparagraph shall not apply to a hospital drug room.

    3.a.An application for a license issued pursuant to the provisions of this subsection shall:

    (1)be submitted to the Board in writing, and

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

    b.An application for each 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.  Applicants 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.

    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 therapeutic preparations that shall be free from living microorganisms (aseptic) shall obtain a pharmacy license, and shall also obtain a parenteral 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 parenteral permits.

    B.  1.  It shall be unlawful for any person to manufacture, package, or wholesale any dangerous drugs, or to engage in selling, or offering for sale at retail, medical gases, except under the management and control of a licensed pharmacist or such other persons as may be approved by the Board after an investigation and determination of such person’s qualifications.  No person shall sell medical gases, or manufacture, package, or wholesale dangerous drugs offered for sale in this state without first obtaining a permit from the Board.

    2.a.An application for an initial or renewal permit issued pursuant to the provisions of this subsection shall be:

    (1)made in writing, and

    (2)accompanied by a permit fee not to exceed Three Hundred Dollars ($300.00) for each period of one (1) year.

    b.Prior to opening for business, all applicants for an initial permit shall be inspected.  Applicants shall pay an inspection fee not to exceed Two Hundred Dollars ($200.00).

    3.  A permit issued pursuant to the provisions of this subsection shall be valid for a period determined by the Board and shall contain the name of the permittee and the address of the place at which such business shall be conducted.

    C.  A licensee or permittee 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:

    a.provisions for new or renewal application requirements for both in- and out-of-state wholesale distributors, chain pharmacy warehouses and repackagers that ship into Oklahoma.  Requirements for new and renewal applications, if such information has not been previously provided to the Board, may include, but need not be limited to, the following:

    (1)type of ownership, whether individual, partnership, limited liability company or corporation,

    (2)names of principal owners or officers and their Social Security numbers,

    (3)names of designated managers and their Social Security numbers,

    (4)applicant’s and designated managers’ fingerprints,

    (5)criminal background check information for the applicants and designated managers as required by rule,

    (6)a copy of the license from the applicant’s or designated managers’ home state, and

    (7)bond requirements, and

    b.provisions for the establishment of a pedigree or electronic file to be used by wholesale distributors, chain pharmacy warehouses and repackagers for the purpose of ensuring the integrity of drugs owned, purchased, distributed, returned, transferred and sold when the products leave the normal distribution channel.

    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.

    3.  The Board may exempt by rule wholesalers accredited by VAWD from the provisions of subparagraphs a and b of paragraph 1 of this subsection.

    4.  The Board shall exempt from the provisions of this subsection logistics providers that receive prescription drugs from original sponsors or manufacturers, deliver the drug products in commerce at the direction of the original sponsor or manufacturer, and do not purchase, sell, trade, or take title to any prescription drug.

    5.  In promulgating such rules, the Board shall seek input from manufacturers, wholesale distributors, chain pharmacy warehouses, logistics providers and repackagers.

    E.  A wholesale distributor shall accept prescription drug returns pursuant to the terms and conditions of the agreement between the wholesale distributor and a hospital, pharmacy, chain pharmacy warehouse or other healthcare entity and these returns shall not be subject to any pedigree or electronic file requirement unless the returns appear suspicious or are greater than the purchases from the wholesale distributor.  Wholesale distributors shall be held accountable for maintaining their return process and ensuring that items returned originated from their operations, that the return process is secure, and that the return process does not permit the entry of adulterated and counterfeit product.

    F.  The Oklahoma Pharmacy Act shall not be construed to prevent the sale of nonprescription drugs in original packages by any merchant or dealer.

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.

Note

NOTE:  Laws 2005, c. 357, § 1 repealed by Laws 2006, c. 16, § 40, emerg. eff. March 29, 2006.