An Act to revise provisions related to pharmacy and to make an appropriation to the State Board of Pharmacy.

Be it enacted by the Legislature of the State of South Dakota:

Section 1. That § 13-33A-4 be AMENDED:

13-33A-4. Any school may acquire and maintain a stock of epinephrine auto-injectors pursuant to a prescription issued by an authorized health care provider for use in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions of this section are not subject to the prescription requirements in subdivision 36-11-2(21) chapter 36-11.

Section 2. That § 36-11-2 be AMENDED:

36-11-2. Terms used in this chapter mean:

(1) "Association," the South Dakota Pharmacists Association;

(2) "Biological product," as defined in 42 U.S.C. § 262(i), as of (January 1, 2018);

(3)(2) "Board," or "board of pharmacy," the State Board of Pharmacy in South Dakota;

(4)(3) "Brand name," the proprietary or registered trademark name given to a drug product by its manufacturer, labeler, or distributor and placed on the drug or on its container, label, or wrapping at the time of packaging;

(5) "Chemicals," the chemical materials or medicine;

(6)(4) "Compounding," the preparation, mixing, assembling, packaging, or labeling of a drug or drug device as the result of a practitioner's prescription drug order or an initiative based on the pharmacist/patient/practitioner relationship in the course of professional practice or for the purpose of or as an incident to research, teaching, or chemical analysis and not for sale or dispensing. The term also includes the preparation of drug or drug devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns;

(7)(5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device from one person to another, whether or not for a consideration;

(8)(6) "Dispense" or "Dispensing," the preparation and delivery of a drug to a patient or a patient's agent pursuant to a prescription drug order in a suitable container with appropriate labeling for subsequent administration to or use by a patient. The term includes preparation of labels for drug devices if the labeling is related to the dosage and administration of drugs;

(9)(7) "Distributing," the delivery of a drug or drug device other than by administration or dispensing;

(10)(8) "Drug administration," the direct application of a drug or drug device by injection, inhalation, ingestion, or any other means to the body of a patient or research subject;

(11)(9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, or other product used in combination with a drug to provide effective management of medication regimens;

(12) "Drug utilization review program," any program operated solely or partially as a professional standards review organization whose purpose is to educate pharmacists and practitioners on severe adverse reactions to drugs, therapeutic appropriateness, overutilization and underutilization, appropriate use of generic products, therapeutic duplication, drug-disease contraindications, drug-drug interactions, incorrect drug dosage or duration of drug treatment, drug-allergy interactions and clinical abuse or misuse, as well as to identify and reduce the frequency of patterns of potential and actual fraud, abuse, gross overuse, inappropriate care or medically unnecessary care associated with specific drugs or groups of drugs among practitioners, pharmacists and patients;

(13)(10) "Equivalent drug product," a drug product, other than a biological product, that is considered to be therapeutically equivalent to other pharmaceutically equivalent products as determined by the latest edition of Approved Drug Products with Therapeutic Equivalence Evaluations, as adopted by the board through rules promulgated pursuant to chapter 1-26;

(14)(11) "Interchangeable biological product," a biological product that the U.S. United States Food and Drug Administration either has licensed and determined meets the standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), as of (January 1, 2018), or has determined is therapeutically equivalent, as set forth in the latest edition of, or any supplement to, the Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations publication as adopted by the board through rules promulgated pursuant to chapter 1-26;

(15)(12) "Labeling," the process of preparing and affixing a label to any drug or drug device container exclusive of the labeling by the manufacturer, packer, or distributor of a nonprescription drug or commercially packaged legend drug or drug device;

(16) "Medical device," an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part or accessory, that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease in man or other animals or is intended to affect the structure or any function of the body of man or other animals, that does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and that is not dependent upon being metabolized for achievement of any of its principal intended purposes;

(17)(13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the prevention, relief, or cure of diseases when used either internally or externally by man or for animals;

(18)(14) "Nonprescription drugs," drugs that are labeled for use by the general public in accordance with § 502 of the Federal Food, Drug and Cosmetic Act as amended through January 1, 1997, 21 U.S.C. § 352 (January 1, 2025), and may be sold without a prescription drug order in accordance with § 503 of the Federal Food, Drug and Cosmetic Act as amended through January 1, 1997 21 U.S.C. § 353 (January 1, 2025). The term does not include drugs which that are required by federal law to bear the statement, "Caution: federal law prohibits dispensing without prescription," drugs intended for human use by hypodermic injection, or animal remedies regulated by chapter 39-18;

(19)(15) "Patient counseling," oral communication by the pharmacist of information to the patient or caregiver, as defined in rules promulgated pursuant to chapter 1-26, to improve therapy by ensuring proper use of drugs and drug devices;

(20)(16) "Pharmaceutical care," provision of drug therapy and other pharmaceutical patient care services intended to achieve outcomes related to cure curing or prevention of preventing a disease, elimination eliminating or reduction of reducing a patient's symptoms, or arresting or slowing of a disease process;

(21)(17) "Pharmacist," a person licensed by the board to engage in the practice of pharmacy;

(22)(18) "Pharmacy," any place of business within or outside this state licensed by the board where drugs are dispensed and pharmaceutical care is provided to residents of this state;

(23)(19) "Practitioner," a person licensed, registered, or otherwise authorized by the jurisdiction in which the person is practicing to prescribe drugs in the course of professional practice;

(24)(20) "Prescription drug order," a written or oral order of a practitioner for a drug or drug device for a specific patient;

(25)(21) "Proper name," the nonproprietary name for a biological product designated by the U.S. United States Food and Drug Administration license for use upon each package of the product; and

(26)(22) "Registered pharmacy technician," a person registered by the board who is employed by a pharmacy to assist licensed pharmacists in the practice of pharmacy by performing specific tasks delegated by and under the immediate personal supervision and control of a licensed pharmacist, as permitted by the board;

(27) "Retail place of business," any place where merchandise is sold at retail and from which original packages of nonprescription drugs are sold or taken to be sold at retail;

(28) "Reverse distributor," any person or business registered with the Drug Enforcement Administration that accepts drug products from vendors and returns the drug products to manufacturers for credit or destruction.

Section 3. That § 36-11-2.1 be AMENDED:

36-11-2.1. Drugs For the purpose of this chapter, "drugs" are defined as follows:

(1) Articles recognized in the official United States Pharmacopoeia or the official National Formulary, as adopted by the board of pharmacy through rules promulgated pursuant to chapter 1-26, or recognized in the official Homeopathic Pharmacopoeia of the United States as in effect on January 1, 1993;

(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals;

(3) Articles (, other than food), intended to affect the structure or any functions of the human body; and

(4) Articles intended for use as a component of any articles specified in this section.

The term "drugs" excludes medical devices.

For the purposes of this section, "medical device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease in humans or animals, or is intended to affect the structure or any function of the body of humans or animals, that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or animals and that is not dependent upon being metabolized for achievement of any of its principal intended purposes.

Section 4. That § 36-11-5 be AMENDED:

36-11-5. The Board of Pharmacy board shall hold meetings for the examination of applicants for licensure and registration, and the transaction of such other business as shall pertain that pertains to its duties. Special meetings of the board may be held whenever it shall be deemed necessary by a majority of the members thereof board. Two Three members of such the board shall constitute constitutes a quorum.

Section 5. That § 36-11-13 be AMENDED:

36-11-13. It is a Class 2 misdemeanor for any person other than a pharmacist registered under the laws of South Dakota to engage in the practice of pharmacy, except as provided by § 36-11-14.

Section 6. That § 36-11-15 be AMENDED:

36-11-15. Any person, other than a registered pharmacist, who compounds or dispenses drugs, medicines, or poisons, or who keeps a pharmacy or store for retailing or compounding medicines, or who takes, uses, or exhibits the title of a registered pharmacist, is guilty of a Class 2 misdemeanor.

Section 7. That § 36-11-16 be AMENDED:

36-11-16. Any person of The board shall issue a license to practice pharmacy to an individual who:

(1) Submits an application prescribed by the board;

(2) Submits an application fee set by the board through rules promulgated in accordance with chapter 1-26, but not exceeding thirty-five dollars;

(3) Is of good moral character and temperate habits,;

(4) Is not less than eighteen years of age, who is;

(5) Is a graduate of a college of pharmacy recognized and approved by the board, and who has ;

(5) Has had the necessary experience as determined by the board in the practice of pharmacy under a regularly licensed pharmacist in a pharmacy where physicians' prescriptions are compounded and who shall pass a satisfactory; and

(6) Has passed an examination prescribed by the State Board of Pharmacy, shall be entitled to a certificate of registration as a licensed pharmacist board.

The board shall have the authority to may allow credit for suitable military and research activities in the field of pharmacy as part of the experience requirement.

Section 8. That § 36-11-19 be AMENDED:

36-11-19. The Board of Pharmacy board may in its discretion grant certificates of registration to such persons as shall furnish with their applications issue a license to practice pharmacy to individual who applies to the board and submits satisfactory proof that they have the individual has been registered licensed by examination in some other another state;, provided that such the other state required a degree of competency at the time such person the individual was licensed at least equal to that required of licentiates in this state at that same time.

The State Board of Pharmacy, in order to be informed, board may, in determining the degree of fitness required by the several other states' boards of pharmacy for granting license and reciprocal registration licensure, join with other states' boards of pharmacy. Every person individual applying for registration licensure pursuant to this section shall pay to the board upon an application a fee, not to exceed one hundred fifty dollars, set by the board by rule promulgated pursuant to chapter 1-26.

Section 9. That § 36-11-19.1 be AMENDED:

36-11-19.1. Registered pharmacists A pharmacist may:

(1) Perform drug administration pursuant to a prescription drug order. The Board of Pharmacy shall establish standards for drug administration pursuant to chapter 1-26 with the approval of a committee composed of two persons appointed by the Board of Pharmacy, two persons appointed by the Board of Nursing and two persons appointed by the Board of Medical and Osteopathic Examiners;

(2) Perform drug reviews;

(3) Perform or participate in scientific or clinical drug or drug‑related research as an investigator or in collaboration with other investigators;

(4) Interpret and apply pharmacokinetic data and other pertinent laboratory data to design safe and effective drug dosage regimens;

(5) Participate in drug and drug device selection pursuant to a prescription drug order;

(6) Initiate or modify drug therapy by protocol or other legal authority established and approved within a licensed health care facility or by a practitioner authorized to prescribe drugs; and

(7) Provide information on prescription drugs, which may include advising, consulting, and educating, as necessary or as required, patients, the public, and other health care providers on the rational, safe and cost‑effective use of drugs, including therapeutic values, content, hazards and appropriate use.

The board shall establish standards for drug administration, in rules promulgated pursuant to chapter 1-26, with the approval of a committee composed of two persons appointed by the board, two persons appointed by the South Dakota Board of Nursing, and two persons appointed by the State Board of Medical and Osteopathic Examiners.

Section 10. That § 36-11-19.5 be AMENDED:

36-11-19.5. Each nonresident pharmacy license expires on June thirtieth following the date of issue issuance. The board shall mail an provide a renewal application for license renewal to each licensee before June first of each year. If the licensee does not submit a renewal application for renewal of the license, accompanied by the annual license the renewal fee is not made, before the expiration date, the existing license lapses on the date of expiration. The board shall promulgate rules, pursuant to chapter 1-26, to establish the renewal fee, which may not exceed two hundred dollars. If the renewal application is submitted after the expiration of the license, the board must assess a fifty-dollar late fee and may reinstate the license.

If a majority of ownership of a licensed nonresident pharmacy changes, the new owners must, within thirty days after the ownership change:

(1) Submit the renewal application, indicating the change of ownership; and

(2) Pay the renewal fee established by the board as provided in this section.

Section 11. That § 36-11-19.6 be AMENDED:

36-11-19.6. The board may deny, revoke, or suspend a nonresident pharmacy registration license for conduct which that causes serious bodily injury or serious psychological injury to a resident of this state, if the board has referred the matter to the regulatory or licensing agency in the state in which the nonresident pharmacy is located and the regulatory or licensing agency fails to initiate an investigation within forty‑five days after the referral.

Any action taken to deny, revoke, or suspend a nonresident pharmacy registration license is a contested case proceeding pursuant to chapter 1-26.

Section 12. That § 36-11-20 be AMENDED:

36-11-20. The Board of Pharmacy board may, in compliance with chapter 1-26, suspend, revoke, or refuse to grant issue or renew a license or certificate of registration to practice pharmacy to any person who:

(1) Is guilty of a felony or a misdemeanor involving moral turpitude, or who is;

(2) Is addicted to the use of alcoholic liquors or narcotic drugs to such an extent as to render him the person unfit to practice pharmacy with reasonable skill and safety; and the board may, in compliance with chapter 1-26, revoke a license for like cause, or any license which has been procured

(3) Procured a license by fraud or by false representation. Any license or registration, or renewal thereof, obtained through fraud or by any fraudulent or false representations shall be void. The board may suspend, revoke or refuse to grant a license or certificate of registration to any person;

(4) Is permitting or engaging in the unauthorized sale of legend or controlled drugs or substances or who the; or

(5) The board finds to be in violation of any law, rule, or regulation governing pharmacists.

Section 13. That § 36-11-23 be AMENDED:

36-11-23. Each To renew a license to practice pharmacy, a pharmacist shall must annually by October first, on or before September thirtieth of each year, submit a renewal application and pay to the board a registry renewal fee to be fixed set by the board in compliance rules promulgated in accordance with chapter 1-26, not to exceed one hundred fifty dollars. Upon application and payment of the fee by a pharmacist, the Board of Pharmacy, the board shall renew the pharmacist's certificate of registration. Any license. If a pharmacist who fails to apply and pay the renewal fee by the due date is subject to suspension of certificate by the board in compliance with chapter 1-26. Any suspended certificate may be reinstated, the license expires.

The board may reinstate an expired license if the individual:

(1) Applies for reinstatement; and

(2) Pays all delinquent fees have been paid, plus a penalty of twenty- five dollars, and the Board of Pharmacy has approved the application for reinstatement, plus a fifty-dollar late fee.

Section 14. That § 36-11-25 be AMENDED:

36-11-25. Pharmacy The board may issue a pharmacy intern certificates may be issued by the Board of Pharmacy certificate to persons an individual who are is gaining experience as a qualification for licensure as a registered pharmacist. Any pharmacy intern granted issued an intern certificate shall perform his the internship pursuant to regulations which shall be rules promulgated by the Board of Pharmacy board in accordance with chapter 1-26. Nothing in this section shall may be construed as giving such a pharmacy intern authority to fill any prescription, except under the supervision and in the presence of the registered pharmacist.

Section 15. That § 36-11-26 be AMENDED:

36-11-26. If the Board of Pharmacy board is satisfied that any person holding a certificate of registration pharmacist is for any reason incompetent or disqualified to perform the duties of a registered pharmacist pursuant to § 36-11-20 or as contemplated by the provisions of this chapter, it may, in compliance with § 36-11-28 chapter 1-26:

(1) Issue a reprimand to the registrant pharmacist;

(2) Place the registrant pharmacist on probation and supervision;

(3) Suspend the registrant's certificate pharmacist's license until he the pharmacist completes a course of therapy, treatment, training, or any combination thereof;

(4) Suspend the registrant's certificate pharmacist's license for a fixed period; and

(5) Revoke the registrant's certificate pharmacist's license.

An individual may appeal a decision of the board as provided in chapter 1-26.

Section 16. That § 36-11-30 be AMENDED:

36-11-30. No A person may not open or operate a pharmacy shall open or be kept open for transaction of business until it has been registered and a permit issued unless the pharmacy is licensed by the State Board of Pharmacy board.

A violation of this section is a Class 2 misdemeanor. Each day of violation is a separate offense.

Section 17. That § 36-11-31 be AMENDED:

36-11-31. No Only a person, copartnership or corporation that has a pharmacy license issued by the board may carry:

(1) Carry on, conduct, or transact business under a name which that contains as a part thereof the term or words "drug department," "drugstore," or "pharmacy," or any term implying the operation of a pharmacy or drugstore, or in any manner by advertisement, circular, poster, sign or otherwise describe; and

(2) Advertise, describe, or refer to a place of business, in any manner, by the terms "drugstore" or "pharmacy," or any other term or words which may be applied to establishments where drugs, medicines, and poisons are usually dispensed or distributed, unless the place of business so conducted is a pharmacy duly authorized and registered by the State Board of Pharmacy implying the operation of a pharmacy.

A violation of this section is a Class 2 misdemeanor.

Section 18. That § 36-11-32 be AMENDED:

36-11-32. Upon The board shall issue a pharmacy license to a pharmacist in good standing, if the pharmacist:

(1) Submits a form prescribed by the State Board of Pharmacy board; and the payment of

(2) Pays a fee, not to exceed two hundred dollars, set by the Board of Pharmacy board in rules promulgated in accordance with chapter 1-26, the State Board of Pharmacy shall issue to pharmacists in good standing, registered under the laws of this state, a permit to conduct a pharmacy.

Section 19. That § 36-11-33 be AMENDED:

36-11-33. The Board of Pharmacy board may issue to pharmacists a pharmacist in good standing a permit license to conduct operate a part‑time, limited, or conditional pharmacy in hospitals a hospital, nursing homes facility, or related facilities facility, provided that the pharmacy services are limited to patients inpatients or residents of the facility.

A permit to conduct a pharmacy, the The board may issue a license under this section if:

(1) The pharmacist submits a form prescribed by the board and pays a fee, not to exceed two hundred dollars, set by the board in rules promulgated in accordance with chapter 1-26; and

(2) The merchandise and fixtures of which the pharmacy are owned by a person, firm, or corporation other than a registered the pharmacist, upon said registered pharmacist making application for a permit hereunder, may be issued and granted to the said registered pharmacist, on compliance applying for the license.

The pharmacist must comply with the provisions of this chapter, and with minimum standards as established by the board in rules promulgated pursuant to chapter 1-26.

Section 20. That § 36-11-34 be AMENDED:

36-11-34. No permit to conduct The board may not issue a pharmacy shall be issued license to any pharmacist applicant unless such pharmacist:

(1) The applicant is the owner, or part owner, of the merchandise and fixtures of the place of business for which such the pharmacy registration license is applied for, or unless;

(2) The application is made jointly with a registered pharmacist owner,; or unless the

(3) The nonpharmacist owner of the merchandise and fixtures of the place of business for which the pharmacy registration license is applied for, has made submitted an affidavit on a form prescribed by the state board of pharmacy delegating complete responsibility for the pharmaceutical services in said place of business to the pharmacist applicant.

Section 21. That § 36-11-35 be AMENDED:

36-11-35. Each permit for a pharmacy shall constitute and signify a legal registration for the pharmacy to which it applies, and shall expire pharmacy license expires on the last day of June thirtieth following the date of issue. To renew a pharmacy license, the pharmacist must submit a renewal application on or before June thirtieth on a form prescribed by the board, and pay the renewal fee set by the board in rules promulgated in accordance with chapter 1-26, but not exceeding two hundred dollars. If the renewal application and fee is submitted after the expiration of the license, the board must assess a fifty-dollar late fee and may reinstate the license.

If a majority ownership of the pharmacy changes, the new owners must, within thirty days after ownership change:

(1) Submit the renewal application, indicating the change of ownership; and

(2) Pay the renewal fee established by the board as provided in this section.

Section 22. That § 36-11-36 be AMENDED:

36-11-36. Each permit for a pharmacy, together with a certificate naming the pharmacist actively conducting said pharmacy, license issued by the State Board of Pharmacy, which shall be a part of said permit, shall board must be exposed posted in a conspicuous place in the pharmacy to which it applies that is viewable by the public.

Section 23. That § 36-11-37 be AMENDED:

36-11-37. Each permit for a A pharmacy license may be transferred to another pharmacist in good standing and registered under the laws of this state without the payment of an additional fee;, provided an application for the transfer of said permit the license is made upon a form prescribed by the State Board of Pharmacy board and upon payment of a fifty dollar fee. The application for transfer must be filed with the secretary thereof board not less more than ten days before after the transfer of such active management is made. If the application for transfer is received by the board after ten days, the pharmacy license is void, and the pharmacist must reapply for the license.

Section 24. That § 36-11-38 be AMENDED:

36-11-38. In the event of the death of the pharmacist permittee in active management, the pharmacy permit license issued to the deceased under this chapter shall, within one hundred twenty days after the date of death of such permittee or on June thirtieth, whichever is sooner, become null and void, unless transfer thereof, the license is transferred as provided in § 36-11-37, shall have been made within the said one hundred twenty day period.

Section 25. That § 36-11-39 be AMENDED:

36-11-39. The change of location of any pharmacy for which a permit license has been issued from one municipality to another within this state, any change in the ownership of such pharmacy, or the cessation of business by such the pharmacy shall, must be reported to the State Board of Pharmacy board within ten days from such the occurrence on forms prescribed by the State Board of Pharmacy board.

Section 26. That § 36-11-41 be AMENDED:

36-11-41. No permit may be issued under 36-11-32 unless A pharmacy licensed by the board must:

(1) The pharmacy is Be equipped with the pharmaceutical instruments and utensils prescribed by the State Board of Pharmacy, and shall possess board in rules promulgated in accordance with chapter 1-26;

(2) Possess a stock of pharmaceuticals adequate to serve the needs of the community in which the pharmacy is located; and

(2)(3) The pharmacy has Have on file at all times the publications and supplements of formularies and drug information prescribed by the board, by rules promulgated pursuant to chapter 1-26; and

(4) Be maintained and operated in a clean and sanitary condition, free from unhealth, foreign, or injurious contamination.

Section 27. That § 36-11-43 be AMENDED:

36-11-43. The Board of Pharmacy board may, in the manner provided by rules promulgated in accordance with chapter 1-26, adopt a code of professional ethics for pharmacists in this state in the practice of their profession. In adopting such code, or any amendments thereafter, the. The board will shall consider the recommendations of the South Dakota Pharmacists Association and the vote of its members, provided however, that any such in adopting the code or changes made thereto. The code so adopted shall at no time may not contain any provision that would in any way restrain, prohibit, or attempt to regulate the rights of any pharmacist to be employed in any a licensed pharmacy holding a valid pharmacy permit. Violation of the code of professional ethics shall may not be the basis for criminal prosecution unless otherwise declared unlawful.

Section 28. That § 36-11-44 be AMENDED:

36-11-44. Any registered pharmacist who permits the compounding or dispensing of prescriptions or the vending of drugs or poisons in his store or in the pharmacist's place of business, except under the personal supervision of a registered pharmacist, or any pharmacist who, while continuing in business, makes any false representations to procure registration for himself a license for the pharmacist or any other person, is guilty of a Class 2 misdemeanor.

Section 29. That § 36-11-48 be AMENDED:

36-11-48. The State Board of Pharmacy board may suspend or revoke, in accordance with chapter 1-26, any permit obtained pharmacy license issued under this chapter on the following grounds:

(1) The license was obtained by false representations made in the application therefor, or when the;

(2) The pharmacy for which the permit shall be license was issued is was kept open for the transaction of business without a registered pharmacist in charge thereof, or upon conviction;

(3) Conviction of a violation of any law of this state or of the United States pertaining to the drug business or for the aiding or abetting in the violation of any such the law;

(4) The active management of the pharmacy was changed without the transfer, as provided in § 36-11-37, of the license;

(5) The location of the pharmacy was changed without the change being reported as provided in § 36-11-39;

(6) The pharmacy was kept open for the transaction of business after the pharmacist ceased to be in active management of the pharmacy; or

(7) The minimum requirements of this chapter and the board are no longer met.

A pharmacy license may not be suspended or revoked except by a vote of three or more members of the board.

Section 30. That § 36-11-67 be AMENDED:

36-11-67. Pharmacists licensed under this chapter A pharmacist or physicians physician licensed under chapter 36-4 who participate on participates in a drug utilization review program as defined in § 36-11-2 are is not individually or jointly not subject to, and are is immune from, claim, suit, liability, damages, or any other recourse, civil or criminal, arising from any act or proceeding, decision, or determination undertaken, performed, or reached in good faith and without malice when acting individually or jointly in carrying out the responsibilities, authority, duties, powers, and privileges of the program conferred upon them under any provisions of law or rule, good faith being presumed until proven otherwise, with malice required to be shown by the complainant.

For the purposes of this section, a "drug utilization review program" is a program operated solely or partially as a professional standards review organization whose purpose is to:

(1) Educate pharmacists and practitioners on:

(a) Severe adverse reactions to drugs;

(b) Therapeutic appropriateness;

(c) Overutilization;

(d) Underutilization;

(e) Appropriate use of generic products;

(f) Therapeutic duplication;

(g) Drug-disease contraindications;

(h) Drug-drug interactions;

(i) Incorrect drug dosage or duration of drug treatment;

(j) Drug-allergy interactions; and

(k) Clinical abuse or misuse; and

(2) Identify and reduce the frequency of patterns of potential and actual fraud, abuse, gross overuse, inappropriate care, or medically unnecessary care associated with specific drugs or groups of drugs among practitioners, pharmacists, and patients.

Section 31. That § 36-11-72 be AMENDED:

36-11-72. The board shall promulgate rules pursuant to chapter 1-26 to provide for the regulation of telepharmacy in the this state. The rules shall include must provide for:

(1) License and renewal application requirements, including establishment:

(a) Establishment of an annual initial license fee and a renewal fee, each not to exceed two hundred fifty dollars;

(b) Procedures for the reinstatement of an expired license; and

(c) Establishment of a late fee for reinstating an expired license, not to exceed fifty dollars;

(2) Minimum structural, security, and equipment requirements for the remote pharmacy;

(3) Minimum staffing requirements for the central pharmacy and remote pharmacy;

(4) Record keeping requirements for the central pharmacy and remote pharmacy;

(5) Establishment of policies Policies and procedures for the daily operation of the remote pharmacy; and

(6) Use of automated dispensing machines.

Section 32. That a NEW SECTION be added to chapter 36-11:

If the majority of ownership of a remote pharmacy changes, the new owners must, within thirty days after the ownership change:

(1) Submit the renewal application prescribed by the board, as provided in § 36-11-72, indicating the change of ownership; and

(2) Pay the renewal fee established by the board, as provided in § 36-11-72.

Section 33. That § 36-11A-8 be AMENDED:

36-11A-8. An applicant for licensure as a To apply for a wholesale or other drug distributor shall apply annually to the board license, a person must submit an application on a form provided by the board. The application shall be accompanied by a and pay an annual license fee set by the board. The fee may not exceed two, not to exceed five hundred fifty dollars.

All financial statements or related information submitted by applicants shall must be treated as confidential materials.

Section 34. That § 36-11A-13 be AMENDED:

36-11A-13. Each wholesale drug distributor license expires on December thirty-first following the date of issue issuance. The board shall provide an application for license renewal to each licensee before December first of each year. To renew a license, the licensee shall submit the renewal application and pay the annual license fee set by the board as provided in § 36-11A-8. If application for renewal of the license accompanied by the annual license fee is not made before the expiration date, the existing license lapses on the date of expiration. If the board receives a renewal application and fee for an expired license, the board must assess a fifty-dollar late fee and may reinstate the license.

If the majority of ownership of a licensed facility changes, the new owners must, within thirty days after the ownership change:

(1) Submit a renewal application, indicating the change of ownership; and

(2) Pay a fee equal to the annual license fee.

Section 35. That § 36-11-3 be REPEALED.

Those registered pharmacists of this state electing to participate shall constitute an association under the name and title of the South Dakota Pharmacists Association. The purpose of the association is to serve as the state professional society of pharmacists which represents the profession of pharmacy, enhances the public's awareness of pharmacy, and serves the best interest of public health and pharmacy. The South Dakota Pharmacists Association shall be conducted as a nonprofit corporation pursuant to the terms of its articles of incorporation. The members of the association who have secured a current annual certificate of registration to practice pharmacy in this state and who have elected to participate in the association are entitled to all of the rights and privileges of the association and may vote, serve as an officer or director of the association, and participate in all of the meetings of the association. The association shall hold an annual meeting at such time and place as it determines.

Section 36. That § 36-11-6 be REPEALED.

The board may, upon receipt, pay to the South Dakota Pharmacists Association eighty percent of all fees the board receives for renewals of certificates of registration as a pharmacist. The association shall use the funds for the following association activities to benefit the public and the profession: continuing education, matters related to registration standards for pharmacists, professional service standards, and general operating expenses related to the activities enumerated in this section. The association shall also use funds received to pay any legislated assessment to support a diversion program for chemically impaired pharmacists. Expenditures of funds shall be approved by the president and treasurer of the association. The association shall annually file in the office of the board an itemized statement of the receipts of the association and disbursements from the receipts.

Section 37. That § 36-11-17 be REPEALED.

Every person initially applying for a certificate of registration with the Board of Pharmacy as a registered pharmacist shall pay to the board with the application a fee, not to exceed thirty-five dollars, set by the board by rule promulgated pursuant to chapter 1-26.

Section 38. That § 36-11-18 be REPEALED.

It shall be the duty of the Board of Pharmacy to examine all applications for registration submitted in due form as provided in the rules and regulations of the board and to grant certificates of registration to such persons as may be entitled to the same under the provisions of this chapter.

Section 39. That § 36-11-22 be REPEALED.

The Board of Pharmacy shall keep a record of registration in which shall be entered the names and places of business of all persons registered under this chapter which records shall also specify such facts as such persons shall claim to justify their registration.

Section 40. That § 36-11-28 be REPEALED.

A certificate of registration as a pharmacist shall not be revoked or suspended except after hearing before the Board of Pharmacy at which a majority of its members are present and in compliance with chapter 1-26.

Section 41. That § 36-11-29 be REPEALED.

An appeal from the decision of the Board of Pharmacy may be taken as provided by chapter 1-26.

Section 42. That § 36-11-40 be REPEALED.

Any permit issued under the provisions of § 36-11-32 shall be void if the active management of any pharmacy is changed without the transfer, as provided in § 36-11-37, of the permit therefor, or if the location of said pharmacy is changed without the same being reported as provided in § 36-11-39, or if the pharmacy is kept open for business after the permittee has ceased to be in active management of said pharmacy, and whenever the minimum requirements of this chapter and the Board of Pharmacy are no longer met.

Section 43. That § 36-11-42 be REPEALED.

Any permit issued under the provisions of § 36-11-32 shall be void and subject to cancellation by the State Board of Pharmacy, unless such pharmacy is maintained and operated in a clean and sanitary condition, free from unhealthful, foreign, or injurious contamination.

Section 44. That § 36-11-49 be REPEALED.

Before any permit for a pharmacy shall be revoked chapter 1-26 shall be complied with. Two members of the board shall constitute a quorum and no permit shall be revoked except by a vote of two or more members of the State Board of Pharmacy.

Section 45. That § 36-11A-4.2 be REPEALED.

No outsourcing facility engaged in compounding of nonpatient specific sterile and nonsterile drugs may become licensed by the board without first obtaining a registration and inspection by the United States Food and Drug Administration, and paying the license fee set by the board in rules promulgated pursuant to chapter 1-26. The fee may not exceed two hundred dollars.

Section 46. No later than September 30, 2025, the Board of Pharmacy shall, pursuant to chapter 1-26, provide for and file with the secretary of state, the amendment of ARSD 20:67:02:01, as set forth below:

20:67:02:01.  Application and fee. A wholesale or other distributor must apply each year to the board, electronically or on a form supplied by the secretary of the board, for a license to engage in the distribution of prescription drugs. Each application shall must be accompanied by a license fee of $200 five hundred dollars.

Source: 18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May 26, 1998; 45 SDR 86, effective December 24, 2018.

General Authority: SDCL 36-11A-14(1),(6).

Law Implemented: SDCL 36-11A-7, 36-11A-8.

Section 47. There is appropriated $200,000 from the general fund, to the State Board of Pharmacy, to reimburse the South Dakota Pharmacists Association for services previously rendered by the association and approved by the board related to continuing education, registration standards, professional service standards, the diversion program for pharmacists, and general operating expenses related thereto.

Section 48. The executive director of the State Board of Pharmacy shall approve vouchers and the state auditor shall draw warrants to pay expenditures authorized in this Act.

Section 49. Any amounts appropriated in this Act not lawfully expended or obligated shall revert in accordance with the procedures prescribed in chapter 4-8.

Section 50. This Act is effective beginning June 30, 2025.