Req. No. 1427 Page 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 STATE OF OKLAHOMA 1st Session of the 59th Legislature (2023) SENATE BILL 765 By: Standridge AS INTRODUCED An Act relating to the practice of pharma cy; defining terms; requiring wholesale distributors to make adequate provisions for the return of certain outdated prescription drugs ; requiring wholesale distributors to establish certain written policy; stating criteria of policy; providing exemption; providing eligibility criteria for drugs; requiring prompt full credit to purchaser; requiring certain notification and documentation; requiring wholesale distributors to maintain certain records; prohibiting submission of drugs under certain conditions; providing for disciplinary action; requiring compliance with applicable laws, rules, and regulations; amending 59 O.S. 2021, Section 353.24 , which relates to unlawful acts; creating exception; updating statutory language; providing for codification; and providing an effective date . BE IT ENACTED BY THE PEOPLE OF T HE STATE OF OKLAHOMA: SECTION 1. NEW LAW A new section of law to be codified in the Oklahoma Statutes as Section 355.5 of Title 59, unless there is created a duplication in numbering, reads as fol lows: A. As used in this section : 1. “Full credit” means a cash refund or credit with t he drug wholesale distributor for the purchase price of the drug as Req. No. 1427 Page 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 established by drug invoice less a reasonable fee for handling of the returned drugs. A reasonable fee shall not be more than seven percent (7%) of the total invoice price of the returned drugs ; and 2. “Reverse drug distributor” means a firm, whether located inside or outside this state, that receives drugs for destruction, return credit, or otherwise disposes of drugs received from a registrant located in this state who holds a permit or license to dispense or possess drugs . As used in this paragraph, “registrant” means a person registered by the Director of the Oklahoma State Bureau of Narcotics and Dangerous Drugs Control under Section 2-302 of Title 63 of the Oklahoma Statutes. B. Effective with all drug orders placed on or after the effective date of this act, all wholesale distributors shall make adequate provisions for the return of outdated pre scription drugs, both full and partial containers, for up to six (6) months after the labeled expiration date for prompt full credit. C. Wholesale distributors shall establish a written policy providing for the return of outdated prescription drugs sold t o a client by such wholesale distributor. Such policy may include a procedure for the drugs to be returned to the drug manufac turer, may include a requirement that the drugs be returned in the original containers in which they were purchased, and may include the use of a reverse drug distribut or. Such policy shall be available to the State Board of Pharmacy or its agents upon reque st. Req. No. 1427 Page 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 D. Influenza vaccines shall be exempt from the requirements of this provision if they have an expiration date of less th an one year from the date such drug is m anufactured. E. In order to be eligible for full credit , the drug must be received by the wholesale distributor, or if not the wholesale distributor, its agent designa ted in its return policy, no later than the sixth month from the labeled expiration date . A signed delivery receipt shall constitute evidence of the drug s having been returned. F. Prompt full credit to the purchaser shall occur within sixty (60) calendar days from the date the return drugs were received b y the wholesale distributor or its d esignated agent. If the wholesale distributor determine s that the drugs were not returned wi thin six (6) months of the labeled expiration date, or were not returned consistent with the written return policy, then the wh olesale distributor shall notify the purchaser in writing within thirty (30) calendar days of the receipt of the drugs of it s intent not to give full credit. Wholesale distributors shall maintain d ocumentation supporting their refusal to give full credit for a period of two (2) years. Such documentation shall be available to the Board or its agent upon request. G. Wholesale distributors shall maintain records of all credits made under this section for a period of two (2) years and such Req. No. 1427 Page 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 record shall be made available to the Board or its agent upon request. H. The submission of drugs by a purchaser licensed by the Boar d in this state for refund or credit to a wholesale distributor pursuant to this section when the drugs are in a container other than the one in which they were purchased, when the drugs were not purchased from that wholesale distributor, or when th e drugs were purchased for a pharmacy or facility outside this state shall constitute fraudulent and unprofess ional conduct and may subject the purchaser to disciplinary action by the Board. I. The return of drugs under this section shall comply with all other applicable federal, state, and local laws, rules, and regulations. SECTION 2. AMENDATORY 59 O.S. 2021, Section 353.24, is amended to read as follows: Section 353.24. A. It shall be unlawful for any licensee or other person to: 1. Forge or increase the quantity of drug in any prescription, or to present a prescription bearing forged, fictitious o r altered information or to possess any drug secured by such forged, fictitious or altered prescription; 2. Sell, offer for sale, barter or give a way any unused quantity of drugs obtained by prescription, except through a program Req. No. 1427 Page 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 pursuant to the Utilizati on of Unused Prescription Medications Act or as otherwise provided by the State Board of Pharmacy; 3. Sell, offer for sale, barter or give away an y drugs damaged by fire, water, or other causes without first obtaining the written approval of the Board or the State Department of Health; 4. No person, firm or business establishment shall offer to the public, in any manner, their services as a “pick-up station” or intermediary for the purpose of having prescriptions filled or delivered, whether for profit or gratuitously. Nor may the owner of any pharmacy or drug store authorize any person, firm or business establishment to act for them in this manner with these exceptions: a. patient-specific filled prescriptions may be delivered or shipped to a prescriber ’s clinic for pick-up by those patients whom the prescriber has i ndividually determined and documented do not have a permanent or secure mailing address, b. patient-specific filled prescriptions for drugs which require special handling written by a prescrib er may be delivered or shipped to the prescriber’s clinic for administration or pick-up at the prescriber ’s office, c. patient-specific filled pres criptions, including sterile compounded drugs, may be delivered or shipped to a prescriber’s clinic where they shall be administered, Req. No. 1427 Page 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 d. patient-specific filled prescriptions for patients with end-stage renal disease (ESRD) may be delivered or shipped to a prescriber ’s clinic for administration or final delivery to the patient, e. patient-specific filled prescriptions for radiopharmaceuticals may be delivered or shipped to a prescriber’s clinic for administration or pick -up, or f. patient-specific filled prescriptions may be delivered or shipped by an Indian Health Services Service (IHS) or federally recognized tribal health organization operating under the IHS in the delivery of the prescriptions to a pharmacy operated by the IHS or a federally recognized tribal health organization for pick-up by an IHS or tribal patient. However, nothing in this paragrap h shall prevent a pharmacist or an employee of the pharmacy from personally recei ving a prescription or delivering a legally filled prescrip tion to a residence, office or place of employment of the patient for whom the prescription was written. Provided f urther, the provisions of this paragraph shall not apply to any Department of Men tal Health and Substance Abuse Services employee or any per son whose facility contracts with the Department of Mental Health and Substance Abuse Services whose possession of any dangerous drug, as defined in Section 353.1 of this title, is for the purpose of delivery of a mental health Req. No. 1427 Page 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 consumer’s medicine to the consumer’s home or residence. Nothing in this paragraph shall prevent veterinary prescription drugs from being shipped directly from an Oklahoma licensed wholesaler or distributor registered with t he Oklahoma State Board of Veterinary Medical Examiners to a clie nt; provided, such drugs may be dispensed only on prescription of a licensed veterinarian and only when an existing veterinary-client-patient relationship exists. Nothing in this paragraph shall prevent dialysate and peritoneal dialysis devices from being shipped directly from an Oklahoma licensed manufacturer, wholesaler or distributor to an ESRD patient or patient’s designee, consistent with subsection F of Section 353.18 of this title; 5. Sell, offer for sale or barter or buy any professional samples except through a program pursuant to the Utilization of Unused Prescription Medications Act; 6. Refuse to permit o r otherwise prevent members of the Board or such representatives thereof from entering and inspecting any and all places, including premises, vehicles, equipment, contents, and records, where drugs, medicine, chemicals or poisons are stored, sold, vended, given away, compounded, dispensed, repackaged, transported, or manufactured; 7. Interfere, refuse to participate in, impede or otherwise obstruct any inspection, investigation or disciplinary proceeding authorized by the Oklahoma Pharmacy Act; Req. No. 1427 Page 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 8. Possess dangerous drugs wi thout a valid prescription or a valid license to possess such drugs; provided, however, this provision shall not apply to a ny Department of Mental Health and Substance Abuse Services employee or any person whose facility contracts with the Department of Me ntal Health and Substance Abuse Services whose possession of any dangerous drug, as defined in Section 353.1 of this title, is for the purpose of delivery of a mental health consumer ’s medicine to the consumer ’s home or residence; 9. Fail to establish and maintain effective controls against the diversion of drugs for any other purpose than legitimate medical, scientific or in dustrial uses as provided by state, federal and local law; 10. Fail to have a written drug diversion detectio n and prevention policy; 11. Possess, sell, offer for sale, barter or give away any quantity of dangerous drugs not listed as a scheduled drug pu rsuant to Sections 2-201 through 2-212 of Title 63 of the Oklahoma Statutes when obtained by prescription bea ring forged, fictitious or altered information. a. A first violation of this section shall constitute a misdemeanor and upon conviction shall be pu nishable by imprisonment in the county jail for a term not more Req. No. 1427 Page 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 than one (1) year and a fine in an amount no t more than One Thousand Dollars ($1,000.00). b. A second violation of this section shall constitute a felony and upon conviction shall be punishabl e by imprisonment in the Department of Corrections for a term not exceeding five (5) years and a fine in an amount not more than Two Thousand Dollars ($2,000.00); 12. Violate a Board order or agreed order; 13. Compromise the security of licensure examina tion materials; or 14. Fail to notify the Board, in writing, within ten (10) days of a licensee or perm it holder’s address change. B. 1. It shall be unlawful for any person o ther than a licensed pharmacist or physician to certify a prescription before delivery to the patient or the patient ’s representative or caregiver. Dialysate and peritoneal dialysis devices supplied pursuant to the provisions of subsection F of Section 35 3.18 of this title shall not be required to be certified by a pharmacist prior to being supplied by a manufacturer, wholesaler or distributor. 2. It shall be unlawful for any perso n to institute or manage a pharmacy unless such person is a licensed pharma cist or has placed a licensed pharmacist in charge of such pharmacy. 3. No licensed pharmacist shall manage, supervise or be in charge of more than one pharmacy. Req. No. 1427 Page 10 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 4. No pharmacist being requested to sell, furnis h or compound any drug, medicine, chemical o r other pharmaceutical preparation, by prescription or otherwise, shall substit ute or cause to be substituted for it, without authority of the prescriber or purchaser, any like dr ug, medicine, chemical or pharmac eutical preparation. 5. No pharmacy, pharma cist-in-charge or other person shall permit the practice of pharmacy except by a licensed pharmacist or assistant pharmacist. 6. No person shall subvert the authority of the ph armacist-in- charge of the pharmacy by impeding the management of the prescription department to act in compliance with federal and state law. C. 1. It Except as provided by Section 1 of this act, it shall be unlawful for a: 1. A pharmacy to resell dangerous drugs to any wholesale distributor. 2. It shall be unlawful for a; or 2. A wholesale distributor to purchase drugs from a pharmacy. SECTION 3. This act shall become effective November 1, 202 3. 59-1-1427 DC 1/18/2023 6:45:11 PM