1 STATE OF OKLAHOMA
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2 1st Session of the 58th Legislature (2021)
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3 SENATE BILL 131 By: Garvin
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6 AS INTRODUCED
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7 An Act relating to pharmacy; amending 59 O.S. 2011,
7 Section 353.18, as last amended by Section 4, Chapter
8 285, O.S.L. 2016 (59 O.S. Supp. 2020, Section
8 353.18), which relates to the sale, manufacturing or
9 packaging of dangerous drugs; providing licensure
9 exception; providing exception to pharmacy
10 requirements for facilities distributing or
10 dispensing dialysate or devices necessary for
11 peritoneal dialysis; amending 59 O.S. 2011, Section
11 353.24, as last amended by Section 6, Chapter 106,
12 O.S.L. 2018 (59 O.S. Supp. 2020, Section 353.24),
12 which relates to unlawful acts; providing certain
13 construction; providing certification exception; and
13 providing an effective date.
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16 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA:
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17 SECTION 1. AMENDATORY 59 O.S. 2011, Section 353.18, as
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18 last amended by Section 4, Chapter 285, O.S.L. 2016 (59 O.S. Supp.
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19 2020, Section 353.18), is amended to read as follows:
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20 Section 353.18. A. 1. It shall be unlawful for any person,
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21 including, but not limited to, Internet, website or online
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22 pharmacies, to sell at retail or to offer for sale, dangerous drugs,
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23 medicines, chemicals or poisons for the treatment of disease,
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24 excluding agricultural chemicals and drugs, or to accept
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 1 prescriptions for same, without first procuring a license from the
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2 State Board of Pharmacy. This licensure requirement applies whether
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3 such sale, offer for sale or acceptance of prescriptions occurs in
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4 this state, or such sale, offer for sale, or acceptance of
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5 prescription prescriptions occurs out of state and the dangerous
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6 drug, medicine, chemical or poison is to be delivered, distributed
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7 or dispensed to patients or customers in this state. This licensure
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8 requirement shall not apply to the distribution or dispensing of
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9 dialysate or peritoneal dialysis devices to patients with end-stage
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10 renal disease (ESRD) consistent with subsection F of this section.
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11 2. A pharmacy license shall be issued to such person as the
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12 Board shall deem qualified upon evidence satisfactory to the Board
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13 that:
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14 a. the place for which the license is sought will be
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15 conducted in full compliance with the law and the
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16 rules of the Board,
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17 b. the location and physical characteristics of the place
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18 are reasonably consistent with the maintenance of
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19 professional surroundings and constitute no known
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20 danger to the public health and safety,
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21 c. the place will be under the management and control of
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22 a licensed pharmacist or pharmacist-in-charge who
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23 shall be licensed as a pharmacist in Oklahoma, and
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 1 d. a licensed pharmacist shall be present and on duty at
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2 all business hours; provided, however, the provisions
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3 of this subparagraph shall not apply to hospital drug
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4 rooms.
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5 3. a. An application for an initial or renewal license
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6 issued pursuant to the provisions of this subsection
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7 shall:
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8 (1) be submitted to the Board in writing,
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9 (2) contain the name or names of persons owning the
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10 pharmacy, and
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11 (3) provide other such information deemed relevant by
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12 the Board.
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13 b. An application for an initial or renewal license shall
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14 be accompanied by a licensing fee not to exceed Three
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15 Hundred Dollars ($300.00) for each period of one (1)
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16 year. Prior to opening for business, all applicants
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17 for an initial license or permit shall be inspected.
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18 An initial licensure applicant shall pay an inspection
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19 fee not to exceed Two Hundred Dollars ($200.00);
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20 provided, however, that no charge shall be made for
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21 the licensing of any Federal Veterans Hospital in the
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22 State of Oklahoma. Non-resident pharmacies shall
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23 reimburse the Board for any actual expenses incurred
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24 for inspections.
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 1 c. A license issued pursuant to the provisions of this
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2 subsection shall be valid for a period set by the
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3 Board and shall contain the name of the licensee and
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4 the address of the place at which such business shall
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5 be conducted.
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6 4. A retail pharmacy that prepares sterile drugs shall obtain a
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7 pharmacy license, and shall also obtain a sterile compounding permit
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8 at a fee set by the Board, not to exceed Seventy-five Dollars
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9 ($75.00). Such pharmacy shall meet requirements set by the Board by
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10 rule for sterile compounding permits.
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11 5. An outsourcing facility desiring to dispense prescriptions
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12 to patients must additionally license and meet the requirements of a
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13 pharmacy.
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14 B. 1. It shall be unlawful for any person to manufacture,
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15 repackage, distribute, outsource, warehouse or be a third-party
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16 logistics provider of any dangerous drugs, medicines, medical gases,
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17 chemicals, or poisons for the treatment of disease, excluding
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18 agricultural chemicals, without first procuring a license from the
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19 Board. It shall be unlawful to sell or offer for sale at retail or
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20 wholesale dangerous drugs, medicines, medical gases, chemicals or
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21 poisons without first procuring a license from the Board. This
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22 licensure requirement shall apply when the manufacturing,
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23 repackaging, distributing, outsourcing, warehousing, or provision of
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24 third-party logistics occurs in this state or out of state for
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 1 delivery, distribution, or dispensing to patients or customers in
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2 this state.
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3 2. A license shall be issued to such person as the Board shall
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4 deem qualified upon satisfactory evidence to the Board that:
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5 a. the place for which the license is sought will be
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6 conducted in full compliance with the laws of this
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7 state and the administrative rules of the Board,
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8 b. the location and physical characteristics of the place
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9 of business are reasonably consistent with the
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10 maintenance of professional surroundings and
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11 constitute no known danger to public health and
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12 safety,
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13 c. the place shall be under the management and control of
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14 such persons as may be approved by the Board after a
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15 review and determination of the persons’
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16 qualifications, and
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17 d. an outsourcing facility shall designate in writing on
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18 a Board-approved form a person to serve as the
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19 pharmacist-in-charge who is a pharmacist licensed by
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20 the Board.
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21 3. a. An application for an initial or renewal license
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22 issued pursuant to the provisions of this subsection
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23 shall:
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24 (1) be submitted to the Board in writing,
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 1 (2) contain the name or names of the owners or the
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2 applicants, and
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3 (3) provide such other information deemed relevant by
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4 the Board.
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5 b. An application for an initial or renewal license shall
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6 be accompanied by a licensing fee not to exceed Three
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7 Hundred Dollars ($300.00) for each period of one (1)
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8 year. Prior to opening for business, all applicants
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9 for initial or renewal license shall be inspected. An
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10 initial licensure applicant shall pay an inspection
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11 fee not to exceed Two Hundred Dollars ($200.00). Non-
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12 resident applicants shall reimburse the Board for any
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13 actual expenses incurred for inspections.
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14 c. A license issued pursuant to the provisions of this
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15 subsection shall contain the name of the licensee and
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16 the address of the place at which such business shall
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17 be conducted and shall be valid for a period of time
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18 set by the Board.
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19 C. A licensee or permit holder who, pursuant to the provisions
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20 of this section, fails to complete an application for a renewal
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21 license or permit by the fifteenth day after the expiration of the
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22 license or permit shall pay a late fee to be fixed by the Board.
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23 D. 1. The Board shall promulgate rules regarding the issuance
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24 and renewal of licenses and permits pursuant to the Oklahoma
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 1 Pharmacy Act which shall include, but need not be limited to,
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2 provisions for new or renewal application requirements for its
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3 licensees and permit holders. Requirements for new and renewal
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4 applications may include, but need not be limited to, the following:
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5 a. type of ownership, whether individual, partnership,
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6 limited liability company or corporation,
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7 b. names and addresses of principal owners or officers
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8 and their Social Security numbers, including
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9 applicant’s full name, all trade or business names
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10 used, full business address, telephone numbers, and
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11 email addresses,
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12 c. names of designated representatives and facility
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13 managers and their Social Security numbers and dates
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14 of birth,
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15 d. evidence of a criminal background check and
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16 fingerprinting of the applicant, if a person, and all
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17 of the applicant’s designated representatives and
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18 facility managers,
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19 e. a copy of the license from the applicant’s home state,
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20 and if applicable, from the federal government,
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21 f. bond requirements, and
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22 g. any other information deemed by the Board to be
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23 necessary to protect the public health and safety.
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 1 2. The Board shall be authorized to use an outside agency, such
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2 as the National Association of Boards of Pharmacy (NABP) or the
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3 Verified-Accredited Wholesale Distributors (VAWD), to accredit
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4 wholesale distributors and repackagers.
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5 E. The Oklahoma Pharmacy Act shall not be construed to prevent
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6 the sale of nonprescription drugs in original manufacturer packages
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7 by any merchant or dealer.
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8 F. The Oklahoma Pharmacy Act shall not be construed to apply to
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9 a facility engaged in the distribution or dispensing to patients of
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10 dialysate or peritoneal dialysis devices necessary to perform home
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11 peritoneal dialysis, provided the following criteria are met:
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12 1. The dialysate is comprised of dextrose or icodextrin;
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13 2. The dialysate or peritoneal dialysis devices are approved or
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14 cleared by the United States Food and Drug Administration;
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15 3. The dialysate or peritoneal dialysis devices are lawfully
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16 held by a manufacturer, or the manufacturer’s agent, who is properly
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17 licensed by the Board as a manufacturer, wholesaler or distributor;
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18 4. The dialysate or peritoneal dialysis devices are held and
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19 delivered in their original, sealed packaging from the manufacturing
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20 facility;
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21 5. The dialysate or peritoneal dialysis devices are delivered
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22 only upon receipt of a physician’s prescription by a licensed
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23 pharmacy, and the transmittal of an order from the licensed pharmacy
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24 to the manufacturer or the manufacturer’s agent; and
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 1 6. The manufacturer or agent of the manufacturer delivers the
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2 dialysate or peritoneal dialysis devices directly to:
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3 a. a patient with ESRD or the patient’s designee for the
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4 patient’s self-administration of the dialysis therapy,
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5 or
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6 b. a health care provider or institution for
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7 administration or delivery of the dialysis therapy to
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8 the patient with ESRD.
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9 SECTION 2. AMENDATORY 59 O.S. 2011, Section 353.24, as
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10 last amended by Section 6, Chapter 106, O.S.L. 2018 (59 O.S. Supp.
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11 2020, Section 353.24), is amended to read as follows:
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12 Section 353.24. A. It shall be unlawful for any licensee or
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13 other person to:
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14 1. Forge or increase the quantity of drug in any prescription,
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15 or to present a prescription bearing forged, fictitious or altered
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16 information or to possess any drug secured by such forged,
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17 fictitious or altered prescription;
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18 2. Sell, offer for sale, barter or give away any unused
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19 quantity of drugs obtained by prescription, except through a program
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20 pursuant to the Utilization of Unused Prescription Medications Act
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21 or as otherwise provided by the State Board of Pharmacy;
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22 3. Sell, offer for sale, barter or give away any drugs damaged
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23 by fire, water, or other causes without first obtaining the written
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24 approval of the Board or the State Department of Health;
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 1 4. No person, firm or business establishment shall offer to the
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2 public, in any manner, their services as a “pick-up station” or
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3 intermediary for the purpose of having prescriptions filled or
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4 delivered, whether for profit or gratuitously. Nor may the owner of
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5 any pharmacy or drug store authorize any person, firm or business
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6 establishment to act for them in this manner with these exceptions:
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7 a. patient-specific filled prescriptions may be delivered
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8 or shipped to a prescriber’s clinic for pick-up by
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9 those patients whom the prescriber has individually
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10 determined and documented do not have a permanent or
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11 secure mailing address,
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12 b. patient-specific filled prescriptions for drugs which
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13 require special handling written by a prescriber may
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14 be delivered or shipped to the prescriber’s clinic for
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15 administration or pick-up at the prescriber’s office,
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16 c. patient-specific filled prescriptions, including
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17 sterile compounded drugs, may be delivered or shipped
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18 to a prescriber’s clinic where they shall be
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19 administered,
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20 d. patient-specific filled prescriptions for patients
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21 with end-stage renal disease (ESRD) may be delivered
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22 or shipped to a prescriber’s clinic for administration
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23 or final delivery to the patient,