South Dakota 2025 Regular Session

South Dakota House Bill HB1016 Compare Versions

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1-25.365.19 100th Legislative Session 1016
1+25.365.18 100th Legislative Session 1016
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33
44 2025 South Dakota Legislature
55 House Bill 1016
6-ENROLLED
7-
8-AN ACT
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10-
11-ENTITLED An Act to revise provisions related to pharmacy and to increase fees.
12-BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA:
13-Section 1. That § 13-33A-4 be AMENDED:
14-13-33A-4. Any school may acquire and maintain a stock of epinephrine auto -
15-injectors pursuant to a prescription issued by an authorized health care provider for use
16-in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions
17-of this section are not subject to the prescription requirements in chapter 36-11.
18-Section 2. That § 36-11-2 be AMENDED:
19-36-11-2. Terms used in this chapter mean:
20-(1) "Biological product," as defined in 42 U.S.C. § 262(i), (January 1, 2018);
21-(2) "Board," the State Board of Pharmacy;
22-(3) "Brand name," the proprietary or registered trademark name given to a drug
23-product by its manufacturer, labeler, or distributor and placed on the drug or on
24-its container, label, or wrapping at the time of packaging;
25-(4) "Compounding," the preparation, mixing, assembling, packaging, or labeling of a
26-drug or drug device as the result of a practitioner's prescription drug order or an
27-initiative based on the pharmacist/patient/practitioner relationship in the course of
28-professional practice or for the purpose of or as an incident to research, teaching,
29-or chemical analysis and not for sale or dispensing. The term also includes the
30-preparation of drug or drug devices in anticipation of prescription drug orders based
31-on routine, regularly observed prescribing patterns;
32-(5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device
33-from one person to another, whether or not for a consideration;
34-(6) "Dispensing," the preparation and delivery of a drug to a patient or a patient's
35-agent pursuant to a prescription drug order in a suitable container with appropriate 25.365.19 2 1016
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37-labeling for subsequent administration to or use by a patient. The term includes
38-preparation of labels for drug devices if the labeling is related to the dosage and
39-administration of drugs;
40-(7) "Distributing," the delivery of a drug or drug device other than by administration
41-or dispensing;
42-(8) "Drug administration," the direct application of a drug or drug device by injection,
43-inhalation, ingestion, or any other means to the body of a patient or research
44-subject;
45-(9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, or
46-other product used in combination with a drug to provide effective management of
47-medication regimens;
48-(10) "Equivalent drug product," a drug product, other than a biological product, that is
49-considered to be therapeutically equivalent to other pharmaceutically equivalent
50-products as determined by the edition of Approved Drug Products with Therapeutic
51-Equivalence Evaluations adopted by the board through rules promulgated pursuant
52-to chapter 1-26;
53-(11) "Interchangeable biological product," a biological product that the United States
54-Food and Drug Administration either has licensed and determined meets the
55-standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), (January 1,
56-2018), or has determined is therapeutically equivalent, as set forth in the edition
57-of Approved Drug Products with Therapeutic Equivalence Evaluations as adopted
58-by the board through rules promulgated pursuant to chapter 1-26;
59-(12) "Labeling," the process of preparing and affixing a label to any drug or drug device
60-container exclusive of the labeling by the manufacturer, packer, or distributor of a
61-nonprescription drug or commercially packaged legend drug or drug device;
62-(13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the
63-prevention, relief, or cure of diseases when used either internally or externally by
64-man or for animals;
65-(14) "Nonprescription drugs," drugs that are labeled for use by the general public in
66-accordance with 21 U.S.C. § 352 (January 1, 2025), and may be sold without a
67-prescription drug order in accordance with 21 U.S.C. § 353 (January 1, 2025). The
68-term does not include drugs that are required by federal law to bear the statement
69-"Caution: federal law prohibits dispensing without prescription," drugs intended for
70-human use by hypodermic injection, or animal remedies regulated by chapter 39-
71-18; 25.365.19 3 1016
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73-(15) "Patient counseling," oral communication by the pharmacist of information to the
74-patient or caregiver to improve therapy by ensuring proper use of drugs and drug
75-devices;
76-(16) "Pharmaceutical care," provision of drug therapy and other pharmaceutical patient
77-care services intended to achieve outcomes related to curing or preventing a
78-disease, eliminating or reducing a patient's symptoms, or arresting or slowing a
79-disease process;
80-(17) "Pharmacist," a person licensed by the board to engage in the practice of
81-pharmacy;
82-(18) "Pharmacy," any place of business within or outside this state where drugs are
83-dispensed and pharmaceutical care is provided to residents of this state;
84-(19) "Practitioner," a person licensed, registered, or otherwise authorized by the
85-jurisdiction in which the person is practicing to prescribe drugs in the course of
86-professional practice;
87-(20) "Prescription drug order," a written or oral order of a practitioner for a drug or drug
88-device for a specific patient;
89-(21) "Proper name," the nonproprietary name for a biological product designated by the
90-United States Food and Drug Administration license for use upon each package of
91-the product; and
92-(22) "Registered pharmacy technician," a person registered by the board who is
93-employed by a pharmacy to assist pharmacists in the practice of pharmacy by
94-performing specific tasks delegated by and under the immediate personal
95-supervision and control of a pharmacist, as permitted by the board.
96-Section 3. That § 36-11-2.1 be AMENDED:
97-36-11-2.1. For the purpose of this chapter, "drugs" are:
98-(1) Articles recognized in the official United States Pharmacopoeia or the official
99-National Formulary, as adopted by the board through rules promulgated pursuant
100-to chapter 1-26, or recognized in the official Homeopathic Pharmacopoeia of the
101-United States as in effect on January 1, 1993;
102-(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention
103-of disease in humans or other animals;
104-(3) Articles, other than food, intended to affect the structure or any functions of the
105-human body; and
106-(4) Articles intended for use as a component of any articles specified in this section. 25.365.19 4 1016
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108-The term "drugs" excludes medical devices.
109-For the purposes of this section, "medical device" means an instrument, apparatus,
110-implement, machine, contrivance, implant, in vitro reagent, or other similar or related
111-article, including any component, part, or accessory, that is intended for use in the
112-diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention
113-of disease in humans or animals, or is intended to affect the structure or any function of
114-the body of humans or animals, that does not achieve any of its princi pal intended
115-purposes through chemical action within or on the body of humans or animals and that is
116-not dependent upon being metabolized for achievement of any of its principal intended
117-purposes.
118-Section 4. That § 36-11-5 be AMENDED:
119-36-11-5. The board shall hold meetings for the examination of applicants for
120-licensure and registration, and the transaction of other business that pertains to its duties.
121-Special meetings of the board may be held whenever deemed necessary by a majority of
122-the board. Three members of the board constitutes a quorum.
123-Section 5. That § 36-11-13 be AMENDED:
124-36-11-13. It is a Class 2 misdemeanor for any person other than a pharmacist to
125-engage in the practice of pharmacy, except as provided by § 36-11-14.
126-Section 6. That § 36-11-15 be AMENDED:
127-36-11-15. Any person, other than a pharmacist, who compounds or dispenses
128-drugs, medicines, or poisons, or who keeps a pharmacy or store for retailing or
129-compounding medicines, or who takes, uses, or exhibits the title of a pharmacist, is guilty
130-of a Class 2 misdemeanor.
131-Section 7. That § 36-11-16 be AMENDED:
132-36-11-16. The board shall issue a license to practice pharmacy to an individual
133-who:
134-(1) Submits an application prescribed by the board;
135-(2) Submits an application fee set by the board through rules promulgated in
136-accordance with chapter 1-26, but not exceeding thirty-five dollars;
137-(3) Is of good moral character and temperate habits; 25.365.19 5 1016
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139-(4) Is not less than eighteen years of age;
140-(5) Is a graduate of a college of pharmacy recognized and approved by the board;
141-(6) Has had the necessary experience as determined by the board in the practice of
142-pharmacy under a regularly licensed pharmacist in a pharmacy where physicians'
143-prescriptions are compounded; and
144-(7) Has passed an examination prescribed by the board.
145-The board may allow credit for suitable military and research activities in the field
146-of pharmacy as part of the experience requirement.
147-Section 8. That § 36-11-19 be AMENDED:
148-36-11-19. The board may issue a license to practice pharmacy to individual who
149-applies to the board and submits satisfactory proof that the individual has been licensed
150-by examination in another state, provided that the other state required a degree of
151-competency at the time the individual was licensed at least equal to that required in this
152-state at that same time.
153-The board may, in determining the degree of fitness required by other states'
154-boards of pharmacy for granting licensure, join with other states' boards of pharmacy.
155-Every individual applying for licensure pursuant to this section shall pay to the board an
156-application fee, not to exceed one hundred fifty dollars, set by the board by rule
157-promulgated pursuant to chapter 1-26.
158-Section 9. That § 36-11-19.1 be AMENDED:
159-36-11-19.1. A pharmacist may:
160-(1) Perform drug administration pursuant to a prescription drug order;
161-(2) Perform drug reviews;
162-(3) Perform or participate in scientific or clinical drug or drug-related research as an
163-investigator or in collaboration with other investigators;
164-(4) Interpret and apply pharmacokinetic data and other pertinent laboratory data to
165-design safe and effective drug dosage regimens;
166-(5) Participate in drug and drug device selection pursuant to a prescription drug order;
167-(6) Initiate or modify drug therapy by protocol or other legal authority established and
168-approved within a licensed health care facility or by a practitioner authorized to
169-prescribe drugs; and
170-(7) Provide information on prescription drugs, which may include advising, consulting,
171-and educating, as necessary or as required, patients, the public, and other health 25.365.19 6 1016
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173-care providers on the rational, safe and cost-effective use of drugs, including
174-therapeutic values, content, hazards and appropriate use.
175-The board shall establish standards for drug administration, in rules promulgated
176-pursuant to chapter 1-26, with the approval of a committee composed of two persons
177-appointed by the board, two persons appointed by the South Dakota Board of Nursing,
178-and two persons appointed by the State Board of Medical and Osteopathic Examiners.
179-Section 10. That § 36-11-19.5 be AMENDED:
180-36-11-19.5. Each nonresident pharmacy license expires on June thirtieth following
181-the date of issuance. The board shall provide a renewal application to each licensee before
182-June first of each year. If the licensee does not submit a renewal application, accompanied
183-by the renewal fee, before the expiration date, the license lapses on the date of expiration.
184-The board shall promulgate rules, pursuant to chapter 1-26, to establish the renewal fee,
185-which may not exceed two hundred dollars. If the renewal application is submitted after
186-the expiration of the license, the board must assess a fifty-dollar late fee and may reinstate
187-the license.
188-If a majority of ownership of a licensed nonresident pharmacy changes, the new
189-owners must, within thirty days after the ownership change:
190-(1) Submit the renewal application, indicating the change of ownership; and
191-(2) Pay the renewal fee established by the board as provided in this section.
192-Section 11. That § 36-11-19.6 be AMENDED:
193-36-11-19.6. The board may deny, revoke, or suspend a nonresident pharmacy
194-license for conduct that causes serious bodily injury or serious psychological injury to a
195-resident of this state, if the board has referred the matter to the regulatory or licensing
196-agency in the state in which the nonresident pharmacy is located and the regulatory or
197-licensing agency fails to initiate an investigation within forty-five days after the referral.
198-Any action taken to deny, revoke, or suspend a nonresident pharmacy license is a
199-contested case proceeding pursuant to chapter 1-26.
200-Section 12. That § 36-11-20 be AMENDED:
201-36-11-20. The board may, in compliance with chapter 1-26, suspend, revoke, or
202-refuse to issue or renew a license to practice pharmacy to any person who:
203-(1) Is guilty of a felony or a misdemeanor involving moral turpitude; 25.365.19 7 1016
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205-(2) Is addicted to the use of alcoholic liquors or narcotic drugs to such an extent as to
206-render the person unfit to practice pharmacy with reasonable skill and safety;
207-(3) Procured a license by fraud or by false representation;
208-(4) Is permitting or engaging in the unauthorized sale of legend or controlled drugs or
209-substances; or
210-(5) The board finds to be in violation of any law, rule, or regulation governing
211-pharmacists.
212-Section 13. That § 36-11-23 be AMENDED:
213-36-11-23. To renew a license to practice pharmacy, a pharmacist must, on or
214-before September thirtieth of each year, submit a renewal application and pay to the board
215-a renewal fee set by the board in rules promulgated in accordance with chapter 1-26, not
216-to exceed one hundred fifty dollars. Upon application and payment of the fee, the board
217-shall renew the license. If a pharmacist fails to apply and pay the renewal fee, the license
218-expires.
219-The board may reinstate an expired license if the individual:
220-(1) Applies for reinstatement; and
221-(2) Pays all delinquent fees, plus a fifty-dollar late fee.
222-Section 14. That § 36-11-25 be AMENDED:
223-36-11-25. The board may issue a pharmacy intern certificate to an individual who
224-is gaining experience as a qualification for licensure as a pharmacist. Any pharmacy intern
225-issued an intern certificate shall perform the internship pursuant to rules promulgated by
226-the board in accordance with chapter 1-26. Nothing in this section may be construed as
227-giving a pharmacy intern authority to fill any prescription, except under the supervision
228-and in the presence of the pharmacist.
229-Section 15. That § 36-11-26 be AMENDED:
230-36-11-26. If the board is satisfied that any pharmacist is incompetent or
231-disqualified to perform the duties of a pharmacist pursuant to § 36-11-20 or as
232-contemplated by the provisions of this chapter, it may, in compliance with chapter 1-26:
233-(1) Issue a reprimand to the pharmacist;
234-(2) Place the pharmacist on probation and supervision; 25.365.19 8 1016
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236-(3) Suspend the pharmacist's license until the pharmacist completes a course of
237-therapy, treatment, training, or any combination thereof;
238-(4) Suspend the pharmacist's license for a fixed period; and
239-(5) Revoke the pharmacist's license.
240-An individual may appeal a decision of the board as provided in chapter 1-26.
241-Section 16. That § 36-11-30 be AMENDED:
242-36-11-30. A person may not open or operate a pharmacy unless the pharmacy is
243-licensed by the board.
244-A violation of this section is a Class 2 misdemeanor. Each day of violation is a
245-separate offense.
246-Section 17. That § 36-11-31 be AMENDED:
247-36-11-31. Only a person that has a pharmacy license issued by the board may:
248-(1) Carry on, conduct, or transact business under a name that contains the term or
249-words "drugstore," "pharmacy," or any term implying the operation of a pharmacy;
250-and
251-(2) Advertise, describe, or refer to a place of business, in any manner, by the terms
252-"drugstore" or "pharmacy," or any other term or words implying the operation of
253-a pharmacy.
254-A violation of this section is a Class 2 misdemeanor.
255-Section 18. That § 36-11-32 be AMENDED:
256-36-11-32. The board shall issue a pharmacy license to a pharmacist in good
257-standing, if the pharmacist:
258-(1) Submits a form prescribed by the board; and
259-(2) Pays a fee, not to exceed two hundred dollars, set by the board in rules
260-promulgated in accordance with chapter 1-26.
261-Section 19. That § 36-11-33 be AMENDED:
262-36-11-33. The board may issue to a pharmacist in good standing a license to
263-operate a part-time pharmacy in a hospital, nursing facility, or related facility, provided
264-that the pharmacy services are limited to inpatients or residents of the facility.
265-The board may issue a license under this section if: 25.365.19 9 1016
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267-(1) The pharmacist submits a form prescribed by the board and pays a fee, not to
268-exceed two hundred dollars, set by the board in rules promulgated in accordance
269-with chapter 1-26; and
270-(2) The merchandise and fixtures of the pharmacy are owned by a person other than
271-the pharmacist applying for the license.
272-The pharmacist must comply with the provisions of this chapter and with minimum
273-standards as established by the board in rules promulgated pursuant to chapter 1-26.
274-Section 20. That § 36-11-34 be AMENDED:
275-36-11-34. The board may not issue a pharmacy license to any pharmacist
276-applicant unless:
277-(1) The applicant is the owner, or part owner, of the merchandise and fixtures of the
278-place of business for which the pharmacy license is applied for;
279-(2) The application is made jointly with a pharmacist owner; or
280-(3) The nonpharmacist owner of the merchandise and fixtures of the place of business
281-for which the pharmacy license is applied for, has submitted an affidavit on a form
282-prescribed by the board delegating complete responsibility for the pharmaceutical
283-services in said place of business to the pharmacist applicant.
284-Section 21. That § 36-11-35 be AMENDED:
285-36-11-35. Each pharmacy license expires on June thirtieth following the date of
286-issue. To renew a pharmacy license, the pharmacist must submit a renewal application on
287-or before June thirtieth on a form prescribed by the board, and pay the renewal fee set
288-by the board in rules promulgated in accordance with chapter 1-26, but not exceeding two
289-hundred dollars. If the renewal application and fee is submitted after the expiration of the
290-license, the board must assess a fifty-dollar late fee and may reinstate the license.
291-If a majority ownership of the pharmacy changes, the new owners must, within
292-thirty days after ownership change:
293-(1) Submit the renewal application, indicating the change of ownership; and
294-(2) Pay the renewal fee established by the board as provided in this section.
295-Section 22. That § 36-11-36 be AMENDED:
296-36-11-36. Each pharmacy license issued by the board must be posted in a place
297-in the pharmacy that is viewable by the public. 25.365.19 10 1016
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299-Section 23. That § 36-11-37 be AMENDED:
300-36-11-37. A pharmacy license may be transferred to another pharmacist,
301-provided an application for the transfer of the license is made upon a form prescribed by
302-the board and upon payment of a fifty dollar fee. The application for transfer must be filed
303-with the board not more than ten days after the transfer of active management is made.
304-If the application for transfer is received by the board after ten days, the pharmacy license
305-is void, and the pharmacist must reapply for the license.
306-Section 24. That § 36-11-38 be AMENDED:
307-36-11-38. In the event of the death of the pharmacist in active management, the
308-pharmacy license issued to the deceased under this chapter shall, within one hundred
309-twenty days after the date of death or on June thirtieth, whichever is sooner, become null
310-and void, unless the license is transferred as provided in § 36-11-37,.
311-Section 25. That § 36-11-39 be AMENDED:
312-36-11-39. The change of location of any pharmacy for which a license has been
313-issued from one municipality to another within this state, or the cessation of business by
314-the pharmacy, must be reported to the board within ten days from the occurrence on
315-forms prescribed by the board.
316-Section 26. That § 36-11-41 be AMENDED:
317-36-11-41. A pharmacy licensed by the board must:
318-(1) Be equipped with the pharmaceutical instruments and utensils prescribed by the
319-board in rules promulgated in accordance with chapter 1-26;
320-(2) Possess a stock of pharmaceuticals adequate to serve the needs of the community
321-in which the pharmacy is located;
322-(3) Have on file at all times the publications and supplements of formularies and drug
323-information prescribed by the board, by rules promulgated pursuant to chapter 1-
324-26; and
325-(4) Be maintained and operated in a clean and sanitary condition, free from unhealth,
326-foreign, or injurious contamination.
327-Section 27. That § 36-11-43 be AMENDED: 25.365.19 11 1016
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329-36-11-43. The board may, in rules promulgated in accordance with chapter 1-26,
330-adopt a code of professional ethics for pharmacists in this state. The board shall consider
331-the recommendations of the South Dakota Pharmacists Association in adopting the code
332-or changes made thereto. The code may not contain any provision that would in any way
333-restrain, prohibit, or attempt to regulate the rights of any pharmacist employed in a
334-licensed pharmacy. Violation of the code of professional ethics may not be the basis for
335-criminal prosecution unless otherwise declared unlawful.
336-Section 28. That § 36-11-44 be AMENDED:
337-36-11-44. Any pharmacist who permits the compounding or dispensing of
338-prescriptions or the vending of drugs in the pharmacist's place of business, except under
339-the personal supervision of a pharmacist, or any pharmacist who, while continuing in
340-business, makes any false representations to procure a license for the pharmacist or any
341-other person, is guilty of a Class 2 misdemeanor.
342-Section 29. That § 36-11-48 be AMENDED:
343-36-11-48. The board may suspend or revoke, in accordance with chapter 1-26,
344-any pharmacy license issued under this chapter on the following grounds:
345-(1) The license was obtained by false representations made in the application therefor;
346-(2) The pharmacy for which the license was issued was kept open for the transaction
347-of business without a pharmacist in charge thereof;
348-(3) Conviction of a violation of any law of this state or of the United States pertaining
349-to the drug business or for the aiding or abetting in the violation of the law;
350-(4) The active management of the pharmacy was changed without the transfer, as
351-provided in § 36-11-37, of the license;
352-(5) The location of the pharmacy was changed without the change being reported as
353-provided in § 36-11-39;
354-(6) The pharmacy was kept open for the transaction of business after the pharmacist
355-ceased to be in active management of the pharmacy; or
356-(7) The minimum requirements of this chapter and the board are no longer met.
357-A pharmacy license may not be suspended or revoked except by a vote of three or
358-more members of the board.
359-Section 30. That § 36-11-67 be AMENDED: 25.365.19 12 1016
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361-36-11-67. A pharmacist or physician licensed under chapter 36-4 who participates
362-in a drug utilization review program is not individually or jointly subject to, and is immune
363-from, claim, suit, liability, damages, or any other recourse, civil or criminal, arising from
364-any act or proceeding, decision, or determination undertaken, performed, or reached in
365-good faith and without malice when acting individually or jointly in carrying out the
366-responsibilities, authority, duties, powers, and privileges of the program conferred upon
367-them under any provisions of law or rule, g ood faith being presumed until proven
368-otherwise, with malice required to be shown by the complainant.
369-For the purposes of this section, a "drug utilization review program" is a program
370-operated solely or partially as a professional standards review organization whose purpose
371-is to:
372-(1) Educate pharmacists and practitioners on:
373-(a) Severe adverse reactions to drugs;
374-(b) Therapeutic appropriateness;
375-(c) Overutilization;
376-(d) Underutilization;
377-(e) Appropriate use of generic products;
378-(f) Therapeutic duplication;
379-(g) Drug-disease contraindications;
380-(h) Drug-drug interactions;
381-(i) Incorrect drug dosage or duration of drug treatment;
382-(j) Drug-allergy interactions; and
383-(k) Clinical abuse or misuse; and
384-(2) Identify and reduce the frequency of patterns of potential and actual fraud, abuse,
385-gross overuse, inappropriate care, or medically unnecessary care associated with
386-specific drugs or groups of drugs among practitioners, pharmacists, and patients.
387-Section 31. That § 36-11-72 be AMENDED:
388-36-11-72. The board shall promulgate rules pursuant to chapter 1-26 to provide
389-for the regulation of telepharmacy in this state. The rules must provide for:
390-(1) License and renewal application requirements, including:
391-(a) Establishment of an initial license fee and a renewal fee, each not to exceed
392-two hundred fifty dollars;
393-(b) Procedures for the reinstatement of an expired license; and 25.365.19 13 1016
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395-(c) Establishment of a late fee for reinstating an expired license, not to exceed
396-fifty dollars;
397-(2) Minimum structural, security, and equipment requirements for the remote
398-pharmacy;
399-(3) Minimum staffing requirements for the central pharmacy and remote pharmacy;
400-(4) Record keeping requirements for the central pharmacy and remote pharmacy;
401-(5) Policies and procedures for the daily operation of the remote pharmacy; and
402-(6) Use of automated dispensing machines.
403-Section 32. That a NEW SECTION be added to chapter 36-11:
404-If the majority of ownership of a remote pharmacy changes, the new owners must,
405-within thirty days after the ownership change:
406-(1) Submit the renewal application prescribed by the board, as provided in § 36-11-
407-72, indicating the change of ownership; and
408-(2) Pay the renewal fee established by the board, as provided in § 36-11-72.
409-Section 33. That § 36-11A-8 be AMENDED:
410-36-11A-8. To apply for a wholesale or other drug distributor license, a person
411-must submit an application on a form provided by the board and pay an annual license
412-fee set by the board, not to exceed five hundred dollars.
413-All financial statements or related information submitted by applicants must be
414-treated as confidential materials.
415-Section 34. That § 36-11A-13 be AMENDED:
416-36-11A-13. Each wholesale drug distributor license expires on December thirty-
417-first following the date of issuance. The board shall provide an application for license
418-renewal to each licensee before December first of each year. To renew a license, the
419-licensee shall submit the renewal application and pay the annual license fee set by the
420-board as provided in § 36-11A-8. If application for renewal of the license accompanied by
421-the annual license fee is not made before the expiration date, the existing license lapses
422-on the date of expiration. If the board receives a renewal application and fee for an expired
423-license, the board must assess a fifty-dollar late fee and may reinstate the license.
424-If the majority of ownership of a licensed facility changes, the new owners must,
425-within thirty days after the ownership change: 25.365.19 14 1016
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427-(1) Submit a renewal application, indicating the change of ownership; and
428-(2) Pay a fee equal to the annual license fee.
429-Section 35. That § 36-11-3 be REPEALED.
430-Section 36. That § 36-11-6 be REPEALED.
431-Section 37. That § 36-11-17 be REPEALED.
432-Section 38. That § 36-11-18 be REPEALED.
433-Section 39. That § 36-11-22 be REPEALED.
434-Section 40. That § 36-11-28 be REPEALED.
435-Section 41. That § 36-11-29 be REPEALED.
436-Section 42. That § 36-11-40 be REPEALED.
437-Section 43. That § 36-11-42 be REPEALED.
438-Section 44. That § 36-11-49 be REPEALED.
439-Section 45. That § 36-11A-4.2 be REPEALED.
440-Section 46. No later than September 30, 2025, the Board of Pharmacy shall, pursuant to
441-chapter 1-26, provide for and file with the secretary of state, the amendment of ARSD
442-20:67:02:01, as set forth below:
443- 20:67:02:01. Application and fee. A wholesale or other distributor must
444-apply each year to the board, electronically or on a form supplied by the board, for a
445-license to engage in the distribution of prescription drugs. Each application must be
446-accompanied by a license fee of five hundred dollars.
447- Source: 18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May
448-26, 1998; 45 SDR 86, effective December 24, 2018.
449- General Authority: SDCL 36-11A-14.
450- Law Implemented: SDCL 36-11A-7, 36-11A-8. 25.365.19 15 1016
451-HB1016 ENROLLED
452-An Act to revise provisions related to pharmacy and to increase fees.
453-
454-
455-
456-
457-I certify that the attached Act originated in
458-the:
459-
460-House as Bill No. 1016
461-
462-
463-
464-Chief Clerk
465-
466-
467-
468-
469-Speaker of the House
470-
471-Attest:
472-
473-
474-
475-
476-Chief Clerk
477-
478-
479-
480-
481-President of the Senate
482-
483-Attest:
6+SENATE ENGROSSED
4847
4858
4869
48710
48811
489-Secretary of the Senate
12+Introduced by: The Chair of the Committee on Health and Human Services at the request of the State Board of
13+Pharmacy
49014
491-
492-
493-House Bill No. 1016
494-File No. ____
495-Chapter No. ______
496-
497-
498-
499-Received at this Executive Office
500-this _____ day of _____________,
501-
502-2025 at ____________M.
503-
504-
505-
506-By
507-for the Governor
508-
509-
510-The attached Act is hereby
511-approved this ________ day of
512-______________, A.D., 2025
513-
514-
515-
516-
517-
518-Governor
519-
520-STATE OF SOUTH DAKOTA ,
521-ss.
522-Office of the Secretary of State
523-
524-
525-Filed ____________, 2025
526- at _________ o'clock __M.
527-
528-
529-
530-
531-
532-Secretary of State
533-
534-
535-
536-By
537-Asst. Secretary of State
538-
539-
15+ Underscores indicate new language.
16+ Overstrikes indicate deleted language.
17+An Act to revise provisions related to pharmacy and to increase fees. 1
18+BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF SOUTH DAKOTA: 2
19+Section 1. That § 13-33A-4 be AMENDED: 3
20+13-33A-4. Any school may acquire and maintain a stock of epinephrine auto -4
21+injectors pursuant to a prescription issued by an authorized health care provider for use 5
22+in an emergency situation of a severe allergic reaction causing anaphylaxis. The provisions 6
23+of this section are not subject to the prescription requirements in subdivision 36-11-2(21) 7
24+chapter 36-11. 8
25+Section 2. That § 36-11-2 be AMENDED: 9
26+36-11-2. Terms used in this chapter mean: 10
27+(1) "Association," the South Dakota Pharmacists Association; 11
28+(2) "Biological product," as defined in 42 U.S.C. § 262(i), as of (January 1, 2018); 12
29+(3)(2) "Board," or "board of pharmacy," the State Board of Pharmacy in South Dakota; 13
30+(4)(3) "Brand name," the proprietary or registered trademark name given to a drug 14
31+product by its manufacturer, labeler, or distributor and placed on the drug or on 15
32+its container, label, or wrapping at the time of packaging; 16
33+(5) "Chemicals," the chemical materials or medicine; 17
34+(6)(4) "Compounding," the preparation, mixing, assembling, packaging , or labeling of a 18
35+drug or drug device as the result of a practitioner's prescription drug order or an 19
36+initiative based on the pharmacist/patient/practitioner relationship in the course of 20
37+professional practice or for the purpose of or as an incident to research, teaching, 21
38+or chemical analysis and not for sale or dispensing. The term also includes the 22
39+preparation of drug or drug devices in anticipation of prescription drug orders based 23
40+on routine, regularly observed prescribing patterns; 24 25.365.18 2 1016
41+ Underscores indicate new language.
42+ Overstrikes indicate deleted language.
43+(7)(5) "Delivery," the actual, constructive, or attempted transfer of a drug or drug device 1
44+from one person to another, whether or not for a consideration; 2
45+(8)(6) "Dispense" or "Dispensing," the preparation and delivery of a drug to a patient or 3
46+a patient's agent pursuant to a prescription drug order in a suitable container with 4
47+appropriate labeling for subsequent administration to or use by a patient. The term 5
48+includes preparation of labels for drug devices if the labeling is related to the 6
49+dosage and administration of drugs; 7
50+(9)(7) "Distributing," the delivery of a drug or drug device other than by administration 8
51+or dispensing; 9
52+(10)(8) "Drug administration," the direct application of a drug or drug device by 10
53+injection, inhalation, ingestion, or any other means to the body of a patient or 11
54+research subject; 12
55+(11)(9) "Drug device," equipment, process, biotechnological entity, diagnostic agent, 13
56+or other product used in combination with a drug to provide effective management 14
57+of medication regimens; 15
58+(12) "Drug utilization review program," any program operated solely or partially as a 16
59+professional standards review organization whose purpose is to educate 17
60+pharmacists and practitioners on severe adverse reactions to drugs, therapeutic 18
61+appropriateness, overutilization and underutilization, appropriate use of generic 19
62+products, therapeutic duplication, drug-disease contraindications, drug-drug 20
63+interactions, incorrect drug dosage or duration of drug treatment, drug -allergy 21
64+interactions and clinical abuse or misuse, as well as to identify and reduce the 22
65+frequency of patterns of potential and actual fraud, abuse, gross overuse, 23
66+inappropriate care or medically unnecessary care associated with specific drugs or 24
67+groups of drugs among practitioners, pharmacists and patients; 25
68+(13)(10) "Equivalent drug product," a drug product, other than a biological product, that 26
69+is considered to be therapeutically equivalent to other pharmaceutically equivalent 27
70+products as determined by the latest edition of Approved Drug Products with 28
71+Therapeutic Equivalence Evaluations, as adopted by the board through rules 29
72+promulgated pursuant to chapter 1-26; 30
73+(14)(11) "Interchangeable biological product," a biological product that the U.S. United 31
74+States Food and Drug Administration either has licensed and determined meets the 32
75+standards for interchangeability pursuant to 42 U.S.C. § 262(k)(4), as of (January 33
76+1, 2018), or has determined is therapeutically equivalent, as set forth in the latest 34
77+edition of, or any supplement to, the Food and Drug Administration's Approved 35 25.365.18 3 1016
78+ Underscores indicate new language.
79+ Overstrikes indicate deleted language.
80+Drug Products with Therapeutic Equivalence Evaluations publication as adopted by 1
81+the board through rules promulgated pursuant to chapter 1-26; 2
82+(15)(12) "Labeling," the process of preparing and affixing a label to any drug or drug 3
83+device container exclusive of the labeling by the manufacturer, packer , or 4
84+distributor of a nonprescription drug or commercially packaged legend drug or drug 5
85+device; 6
86+(16) "Medical device," an instrument, apparatus, implement, machine, contrivance, 7
87+implant, in vitro reagent or other similar or related article, including any 8
88+component, part or accessory, that is intended for use in the diagnosis of disease 9
89+or other conditions or in the cure, mitigation, treatment or prevention of disease 10
90+in man or other animals or is intended to affect the structure or any function of the 11
91+body of man or other animals, that does not achieve any of its principal intended 12
92+purposes through chemical action within or on the body of man or other animals 13
93+and that is not dependent upon being metabolized for achievement of any of its 14
94+principal intended purposes; 15
95+(17)(13) "Medicines," drugs or chemicals, or their preparations, in suitable form for the 16
96+prevention, relief, or cure of diseases when used either internally or externally by 17
97+man or for animals; 18
98+(18)(14) "Nonprescription drugs," drugs that are labeled for use by the general public in 19
99+accordance with § 502 of the Federal Food, Drug and Cosmetic Act as amended 20
100+through January 1, 1997, 21 U.S.C. § 352 (January 1, 2025), and may be sold 21
101+without a prescription drug order in accordance with § 503 of the Federal Food, 22
102+Drug and Cosmetic Act as amended through January 1, 1997 21 U.S.C. § 353 23
103+(January 1, 2025). The term does not include drugs which that are required by 24
104+federal law to bear the statement, "Caution: federal law prohibits dispensing 25
105+without prescription," drugs intended for human use by hypodermic injection, or 26
106+animal remedies regulated by chapter 39-18; 27
107+(19)(15) "Patient counseling," oral communication by the pharmacist of information to 28
108+the patient or caregiver, as defined in rules promulgated pursuant to chapter 1-26, 29
109+to improve therapy by ensuring proper use of drugs and drug devices; 30
110+(20)(16) "Pharmaceutical care," provision of drug therapy and other pharmaceutical 31
111+patient care services intended to achieve outcomes related to cure curing or 32
112+prevention of preventing a disease, elimination eliminating or reduction of reducing 33
113+a patient's symptoms, or arresting or slowing of a disease process; 34 25.365.18 4 1016
114+ Underscores indicate new language.
115+ Overstrikes indicate deleted language.
116+(21)(17) "Pharmacist," a person licensed by the board to engage in the practice of 1
117+pharmacy; 2
118+(22)(18) "Pharmacy," any place of business within or outside this state licensed by the 3
119+board where drugs are dispensed and pharmaceutical care is provided to residents 4
120+of this state; 5
121+(23)(19) "Practitioner," a person licensed, registered, or otherwise authorized by the 6
122+jurisdiction in which the person is practicing to prescribe drugs in the course of 7
123+professional practice; 8
124+(24)(20) "Prescription drug order," a written or oral order of a practitioner for a drug or 9
125+drug device for a specific patient; 10
126+(25)(21) "Proper name," the nonproprietary name for a biological product designated by 11
127+the U.S. United States Food and Drug Administration license for use upon each 12
128+package of the product; and 13
129+(26)(22) "Registered pharmacy technician," a person registered by the board who is 14
130+employed by a pharmacy to assist licensed pharmacists in the practice of pharmacy 15
131+by performing specific tasks delegated by and under the immediate personal 16
132+supervision and control of a licensed pharmacist, as permitted by the board; 17
133+(27) "Retail place of business," any place where merchandise is sold at retail and from 18
134+which original packages of nonprescription drugs are sold or taken to be sold at 19
135+retail; 20
136+(28) "Reverse distributor," any person or business registered with the Drug Enforcement 21
137+Administration that accepts drug products from vendors and returns the drug 22
138+products to manufacturers for credit or destruction. 23
139+Section 3. That § 36-11-2.1 be AMENDED: 24
140+36-11-2.1. Drugs For the purpose of this chapter, "drugs" are defined as follows: 25
141+(1) Articles recognized in the official United States Pharmacopoeia or the official 26
142+National Formulary, as adopted by the board of pharmacy through rules 27
143+promulgated pursuant to chapter 1-26, or recognized in the official Homeopathic 28
144+Pharmacopoeia of the United States as in effect on January 1, 1993; 29
145+(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention 30
146+of disease in humans or other animals; 31
147+(3) Articles (, other than food), intended to affect the structure or any functions of the 32
148+human body; and 33
149+(4) Articles intended for use as a component of any articles specified in this section. 34 25.365.18 5 1016
150+ Underscores indicate new language.
151+ Overstrikes indicate deleted language.
152+The term "drugs" excludes medical devices. 1
153+For the purposes of this section, "medical device" means an instrument, apparatus, 2
154+implement, machine, contrivance, implant, in vitro reagent, or other similar or related 3
155+article, including any component, part, or accessory, that is intended for use in the 4
156+diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention 5
157+of disease in humans or animals, or is intended to affect the structure or any function of 6
158+the body of humans or animals, that does not achieve any of its principal intended 7
159+purposes through chemical action within or on the body of humans or animals and that is 8
160+not dependent upon being metabolized for achievement of any of its principal intended 9
161+purposes. 10
162+Section 4. That § 36-11-5 be AMENDED: 11
163+36-11-5. The Board of Pharmacy board shall hold meetings for the examination of 12
164+applicants for licensure and registration, and the transaction of such other business as 13
165+shall pertain that pertains to its duties. Special meetings of the board may be held 14
166+whenever it shall be deemed necessary by a majority of the members thereof board. Two 15
167+Three members of such the board shall constitute constitutes a quorum. 16
168+Section 5. That § 36-11-13 be AMENDED: 17
169+36-11-13. It is a Class 2 misdemeanor for any person other than a pharmacist 18
170+registered under the laws of South Dakota to engage in the practice of pharmacy, except 19
171+as provided by § 36-11-14. 20
172+Section 6. That § 36-11-15 be AMENDED: 21
173+36-11-15. Any person, other than a registered pharmacist, who compounds or 22
174+dispenses drugs, medicines, or poisons, or who keeps a pharmacy or store for retailing or 23
175+compounding medicines, or who takes, uses , or exhibits the title of a registered 24
176+pharmacist, is guilty of a Class 2 misdemeanor. 25
177+Section 7. That § 36-11-16 be AMENDED: 26
178+36-11-16. Any person of The board shall issue a license to practice pharmacy to 27
179+an individual who: 28
180+(1) Submits an application prescribed by the board; 29 25.365.18 6 1016
181+ Underscores indicate new language.
182+ Overstrikes indicate deleted language.
183+(2) Submits an application fee set by the board through rules promulgated in 1
184+accordance with chapter 1-26, but not exceeding thirty-five dollars; 2
185+(3) Is of good moral character and temperate habits,; 3
186+(4) Is not less than eighteen years of age, who is; 4
187+(5) Is a graduate of a college of pharmacy recognized and approved by the board, and 5
188+who has ; 6
189+(6) Has had the necessary experience as determined by the board in the practice of 7
190+pharmacy under a regularly licensed pharmacist in a pharmacy where physicians' 8
191+prescriptions are compounded and who shall pass a satisfactory; and 9
192+(7) Has passed an examination prescribed by the State Board of Pharmacy, shall be 10
193+entitled to a certificate of registration as a licensed pharmacist board. 11
194+The board shall have the authority to may allow credit for suitable military and 12
195+research activities in the field of pharmacy as part of the experience requirement. 13
196+Section 8. That § 36-11-19 be AMENDED: 14
197+36-11-19. The Board of Pharmacy board may in its discretion grant certificates of 15
198+registration to such persons as shall furnish with their applications issue a license to 16
199+practice pharmacy to individual who applies to the board and submits satisfactory proof 17
200+that they have the individual has been registered licensed by examination in some other 18
201+another state;, provided that such the other state required a degree of competency at the 19
202+time such person the individual was licensed at least equal to that required of licentiates 20
203+in this state at that same time. 21
204+The State Board of Pharmacy, in order to be informed, board may, in determining 22
205+the degree of fitness required by the several other states' boards of pharmacy for granting 23
206+license and reciprocal registration licensure, join with other states' boards of pharmacy. 24
207+Every person individual applying for registration licensure pursuant to this section shall 25
208+pay to the board upon an application a fee, not to exceed one hundred fifty dollars, set by 26
209+the board by rule promulgated pursuant to chapter 1-26. 27
210+Section 9. That § 36-11-19.1 be AMENDED: 28
211+36-11-19.1. Registered pharmacists A pharmacist may: 29
212+(1) Perform drug administration pursuant to a prescription drug order. The Board of 30
213+Pharmacy shall establish standards for drug administration pursuant to chapter 1-31
214+26 with the approval of a committee composed of two persons appointed by the 32 25.365.18 7 1016
215+ Underscores indicate new language.
216+ Overstrikes indicate deleted language.
217+Board of Pharmacy, two persons appointed by the Board of Nursing and two 1
218+persons appointed by the Board of Medical and Osteopathic Examiners ; 2
219+(2) Perform drug reviews; 3
220+(3) Perform or participate in scientific or clinical drug or drug-related research as an 4
221+investigator or in collaboration with other investigators; 5
222+(4) Interpret and apply pharmacokinetic data and other pertinent laboratory data to 6
223+design safe and effective drug dosage regimens; 7
224+(5) Participate in drug and drug device selection pursuant to a prescription drug order; 8
225+(6) Initiate or modify drug therapy by protocol or other legal authority established and 9
226+approved within a licensed health care facility or by a practitioner authorized to 10
227+prescribe drugs; and 11
228+(7) Provide information on prescription drugs, which may include advising, consulting, 12
229+and educating, as necessary or as required, patients, the public, and other health 13
230+care providers on the rational, safe and cost-effective use of drugs, including 14
231+therapeutic values, content, hazards and appropriate use. 15
232+The board shall establish standards for drug administration, in rules promulgated 16
233+pursuant to chapter 1-26, with the approval of a committee composed of two persons 17
234+appointed by the board, two persons appointed by the South Dakota Board of Nursing, 18
235+and two persons appointed by the State Board of Medical and Osteopathic Examiners. 19
236+Section 10. That § 36-11-19.5 be AMENDED: 20
237+36-11-19.5. Each nonresident pharmacy license expires on June thirtieth following 21
238+the date of issue issuance. The board shall mail an provide a renewal application for license 22
239+renewal to each licensee before June first of each year. If the licensee does not submit a 23
240+renewal application for renewal of the license, accompanied by the annual license the 24
241+renewal fee is not made, before the expiration date, the existing license lapses on the 25
242+date of expiration. The board shall promulgate rules, pursuant to chapter 1-26, to establish 26
243+the renewal fee, which may not exceed two hundred dollars. If the renewal application is 27
244+submitted after the expiration of the license, the board must assess a fifty-dollar late fee 28
245+and may reinstate the license. 29
246+If a majority of ownership of a licensed nonresident pharmacy changes, the new 30
247+owners must, within thirty days after the ownership change: 31
248+(1) Submit the renewal application, indicating the change of ownership; and 32
249+(2) Pay the renewal fee established by the board as provided in this section. 33 25.365.18 8 1016
250+ Underscores indicate new language.
251+ Overstrikes indicate deleted language.
252+Section 11. That § 36-11-19.6 be AMENDED: 1
253+36-11-19.6. The board may deny, revoke, or suspend a nonresident pharmacy 2
254+registration license for conduct which that causes serious bodily injury or serious 3
255+psychological injury to a resident of this state, if the board has referred the matter to the 4
256+regulatory or licensing agency in the state in which the nonresident pharmacy is located 5
257+and the regulatory or licensing agency fails to initiate an investigation within forty-five 6
258+days after the referral. 7
259+Any action taken to deny, revoke, or suspend a nonresident pharmacy registration 8
260+license is a contested case proceeding pursuant to chapter 1-26. 9
261+Section 12. That § 36-11-20 be AMENDED: 10
262+36-11-20. The Board of Pharmacy board may, in compliance with chapter 1-26, 11
263+suspend, revoke, or refuse to grant issue or renew a license or certificate of registration 12
264+to practice pharmacy to any person who: 13
265+(1) Is guilty of a felony or a misdemeanor involving moral turpitude, or who is; 14
266+(2) Is addicted to the use of alcoholic liquors or narcotic drugs to such an extent as to 15
267+render him the person unfit to practice pharmacy with reasonable skill and safety; 16
268+and the board may, in compliance with chapter 1-26, revoke a license for like 17
269+cause, or any license which has been procured 18
270+(3) Procured a license by fraud or by false representation. Any license or registration, 19
271+or renewal thereof, obtained through fraud or by any fraudulent or false 20
272+representations shall be void. The board may suspend, revoke or refuse to grant a 21
273+license or certificate of registration to any person; 22
274+(4) Is permitting or engaging in the unauthorized sale of legend or controlled drugs or 23
275+substances or who the; or 24
276+(5) The board finds to be in violation of any law, rule, or regulation governing 25
277+pharmacists. 26
278+Section 13. That § 36-11-23 be AMENDED: 27
279+36-11-23. Each To renew a license to practice pharmacy, a pharmacist shall must 28
280+annually by October first, on or before September thirtieth of each year, submit a renewal 29
281+application and pay to the board a registry renewal fee to be fixed set by the board in 30
282+compliance rules promulgated in accordance with chapter 1-26, not to exceed one hundred 31
283+fifty dollars. Upon application and payment of the fee by a pharmacist, the Board of 32 25.365.18 9 1016
284+ Underscores indicate new language.
285+ Overstrikes indicate deleted language.
286+Pharmacy, the board shall renew the pharmacist's certificate of registration. Any license. 1
287+If a pharmacist who fails to apply and pay the renewal fee by the due date is subject to 2
288+suspension of certificate by the board in compliance with chapter 1-26. Any suspended 3
289+certificate may be reinstated, the license expires. 4
290+The board may reinstate an expired license if the individual: 5
291+(1) Applies for reinstatement; and 6
292+(2) Pays all delinquent fees have been paid, plus a penalty of twenty- five dollars, and 7
293+the Board of Pharmacy has approved the application for reinstatement, plus a fifty-8
294+dollar late fee. 9
295+Section 14. That § 36-11-25 be AMENDED: 10
296+36-11-25. Pharmacy The board may issue a pharmacy intern certificates may be 11
297+issued by the Board of Pharmacy certificate to persons an individual who are is gaining 12
298+experience as a qualification for licensure as a registered pharmacist. Any pharmacy intern 13
299+granted issued an intern certificate shall perform his the internship pursuant to regulations 14
300+which shall be rules promulgated by the Board of Pharmacy board in accordance with 15
301+chapter 1-26. Nothing in this section shall may be construed as giving such a pharmacy 16
302+intern authority to fill any prescription, except under the supervision and in the presence 17
303+of the registered pharmacist. 18
304+Section 15. That § 36-11-26 be AMENDED: 19
305+36-11-26. If the Board of Pharmacy board is satisfied that any person holding a 20
306+certificate of registration pharmacist is for any reason incompetent or disqualified to 21
307+perform the duties of a registered pharmacist pursuant to § 36-11-20 or as contemplated 22
308+by the provisions of this chapter, it may, in compliance with § 36-11-28 chapter 1-26: 23
309+(1) Issue a reprimand to the registrant pharmacist; 24
310+(2) Place the registrant pharmacist on probation and supervision; 25
311+(3) Suspend the registrant's certificate pharmacist's license until he the pharmacist 26
312+completes a course of therapy, treatment, training, or any combination thereof; 27
313+(4) Suspend the registrant's certificate pharmacist's license for a fixed period; and 28
314+(5) Revoke the registrant's certificate pharmacist's license. 29
315+An individual may appeal a decision of the board as provided in chapter 1-26. 30
316+Section 16. That § 36-11-30 be AMENDED: 31 25.365.18 10 1016
317+ Underscores indicate new language.
318+ Overstrikes indicate deleted language.
319+36-11-30. No A person may not open or operate a pharmacy shall open or be kept 1
320+open for transaction of business until it has been registered and a permit issued unless 2
321+the pharmacy is licensed by the State Board of Pharmacy board. 3
322+A violation of this section is a Class 2 misdemeanor. Each day of violation is a 4
323+separate offense. 5
324+Section 17. That § 36-11-31 be AMENDED: 6
325+36-11-31. No Only a person, copartnership or corporation that has a pharmacy 7
326+license issued by the board may carry: 8
327+(1) Carry on, conduct, or transact business under a name which that contains as a part 9
328+thereof the term or words "drug department," "drugstore," or "pharmacy," or any 10
329+term implying the operation of a pharmacy or drugstore, or in any manner by 11
330+advertisement, circular, poster, sign or otherwise describe; and 12
331+(2) Advertise, describe, or refer to a place of business, in any manner, by the terms 13
332+"drugstore" or "pharmacy," or any other term or words which may be applied to 14
333+establishments where drugs, medicines, and poisons are usually dispensed or 15
334+distributed, unless the place of business so conducted is a pharmacy duly 16
335+authorized and registered by the State Board of Pharmacy implying the operation 17
336+of a pharmacy. 18
337+A violation of this section is a Class 2 misdemeanor. 19
338+Section 18. That § 36-11-32 be AMENDED: 20
339+36-11-32. Upon The board shall issue a pharmacy license to a pharmacist in good 21
340+standing, if the pharmacist: 22
341+(1) Submits a form prescribed by the State Board of Pharmacy board; and the payment 23
342+of 24
343+(2) Pays a fee, not to exceed two hundred dollars, set by the Board of Pharmacy board 25
344+in rules promulgated in accordance with chapter 1-26, the State Board of Pharmacy 26
345+shall issue to pharmacists in good standing, registered under the laws of this state, 27
346+a permit to conduct a pharmacy. 28
347+Section 19. That § 36-11-33 be AMENDED: 29
348+36-11-33. The Board of Pharmacy board may issue to pharmacists a pharmacist 30
349+in good standing a permit license to conduct operate a part-time, limited, or conditional 31 25.365.18 11 1016
350+ Underscores indicate new language.
351+ Overstrikes indicate deleted language.
352+pharmacy in hospitals a hospital, nursing homes facility, or related facilities facility, 1
353+provided that the pharmacy services are limited to patients inpatients or residents of the 2
354+facility. 3
355+A permit to conduct a pharmacy, the The board may issue a license under this 4
356+section if: 5
357+(1) The pharmacist submits a form prescribed by the board and pays a fee, not to 6
358+exceed two hundred dollars, set by the board in rules promulgated in accordance 7
359+with chapter 1-26; and 8
360+(2) The merchandise and fixtures of which the pharmacy are owned by a person, firm, 9
361+or corporation other than a registered the pharmacist, upon said registered 10
362+pharmacist making application for a permit hereunder, may be issued and granted 11
363+to the said registered pharmacist, on compliance applying for the license. 12
364+The pharmacist must comply with the provisions of this chapter, and with minimum 13
365+standards as established by the board in rules promulgated pursuant to chapter 1-26. 14
366+Section 20. That § 36-11-34 be AMENDED: 15
367+36-11-34. No permit to conduct The board may not issue a pharmacy shall be 16
368+issued license to any pharmacist applicant unless such pharmacist: 17
369+(1) The applicant is the owner, or part owner, of the merchandise and fixtures of the 18
370+place of business for which such the pharmacy registration license is applied for, 19
371+or unless; 20
372+(2) The application is made jointly with a registered pharmacist owner,; or unless the 21
373+(3) The nonpharmacist owner of the merchandise and fixtures of the place of business 22
374+for which the pharmacy registration license is applied for, has made submitted an 23
375+affidavit on a form prescribed by the state board of pharmacy delegating complete 24
376+responsibility for the pharmaceutical services in said place of business to the 25
377+pharmacist applicant. 26
378+Section 21. That § 36-11-35 be AMENDED: 27
379+36-11-35. Each permit for a pharmacy shall constitute and signify a legal 28
380+registration for the pharmacy to which it applies, and shall expire pharmacy license expires 29
381+on the last day of June thirtieth following the date of issue. To renew a pharmacy license, 30
382+the pharmacist must submit a renewal application on or before June thirtieth on a form 31
383+prescribed by the board, and pay the renewal fee set by the board in rules promulgated 32
384+in accordance with chapter 1-26, but not exceeding two hundred dollars. If the renewal 33 25.365.18 12 1016
385+ Underscores indicate new language.
386+ Overstrikes indicate deleted language.
387+application and fee is submitted after the expiration of the license, the board must assess 1
388+a fifty-dollar late fee and may reinstate the license. 2
389+If a majority ownership of the pharmacy changes, the new owners must, within 3
390+thirty days after ownership change: 4
391+(1) Submit the renewal application, indicating the change of ownership; and 5
392+(2) Pay the renewal fee established by the board as provided in this section. 6
393+Section 22. That § 36-11-36 be AMENDED: 7
394+36-11-36. Each permit for a pharmacy, together with a certificate naming the 8
395+pharmacist actively conducting said pharmacy, license issued by the State Board of 9
396+Pharmacy, which shall be a part of said permit, shall board must be exposed posted in a 10
397+conspicuous place in the pharmacy to which it applies that is viewable by the public. 11
398+Section 23. That § 36-11-37 be AMENDED: 12
399+36-11-37. Each permit for a A pharmacy license may be transferred to another 13
400+pharmacist in good standing and registered under the laws of this state without the 14
401+payment of an additional fee;, provided an application for the transfer of said permit the 15
402+license is made upon a form prescribed by the State Board of Pharmacy board and upon 16
403+payment of a fifty dollar fee. The application for transfer must be filed with the secretary 17
404+thereof board not less more than ten days before after the transfer of such active 18
405+management is made. If the application for transfer is received by the board after ten 19
406+days, the pharmacy license is void, and the pharmacist must reapply for the license. 20
407+Section 24. That § 36-11-38 be AMENDED: 21
408+36-11-38. In the event of the death of the pharmacist permittee in active 22
409+management, the pharmacy permit license issued to the deceased under this chapter 23
410+shall, within one hundred twenty days after the date of death of such permittee or on June 24
411+thirtieth, whichever is sooner, become null and void, unless transfer thereof, the license 25
412+is transferred as provided in § 36-11-37, shall have been made within the said one 26
413+hundred twenty day period. 27
414+Section 25. That § 36-11-39 be AMENDED: 28
415+36-11-39. The change of location of any pharmacy for which a permit license has 29
416+been issued from one municipality to another within this state , any change in the 30 25.365.18 13 1016
417+ Underscores indicate new language.
418+ Overstrikes indicate deleted language.
419+ownership of such pharmacy, or the cessation of business by such the pharmacy shall, 1
420+must be reported to the State Board of Pharmacy board within ten days from such the 2
421+occurrence on forms prescribed by the State Board of Pharmacy board. 3
422+Section 26. That § 36-11-41 be AMENDED: 4
423+36-11-41. No permit may be issued under 36-11-32 unlessA pharmacy licensed 5
424+by the board must: 6
425+(1) The pharmacy is Be equipped with the pharmaceutical instruments and utensils 7
426+prescribed by the State Board of Pharmacy, and shall possess board in rules 8
427+promulgated in accordance with chapter 1-26; 9
428+(2) Possess a stock of pharmaceuticals adequate to serve the needs of the community 10
429+in which the pharmacy is located; and 11
430+(2)(3) The pharmacy has Have on file at all times the publications and supplements of 12
431+formularies and drug information prescribed by the board, by rules promulgated 13
432+pursuant to chapter 1-26; and 14
433+(4) Be maintained and operated in a clean and sanitary condition, free from unhealth, 15
434+foreign, or injurious contamination. 16
435+Section 27. That § 36-11-43 be AMENDED: 17
436+36-11-43. The Board of Pharmacy board may, in the manner provided by rules 18
437+promulgated in accordance with chapter 1-26, adopt a code of professional ethics for 19
438+pharmacists in this state in the practice of their profession. In adopting such code, or any 20
439+amendments thereafter, the. The board will shall consider the recommendations of the 21
440+South Dakota Pharmacists Association and the vote of its members, provided however, 22
441+that any such in adopting the code or changes made thereto. The code so adopted shall 23
442+at no time may not contain any provision that would in any way restrain, prohibit, or 24
443+attempt to regulate the rights of any pharmacist to be employed in any a licensed 25
444+pharmacy holding a valid pharmacy permit. Violation of the code of professional ethics 26
445+shall may not be the basis for criminal prosecution unless otherwise declared unlawful. 27
446+Section 28. That § 36-11-44 be AMENDED: 28
447+36-11-44. Any registered pharmacist who permits the compounding or dispensing 29
448+of prescriptions or the vending of drugs or poisons in his store or in the pharmacist's place 30
449+of business, except under the personal supervision of a registered pharmacist, or any 31 25.365.18 14 1016
450+ Underscores indicate new language.
451+ Overstrikes indicate deleted language.
452+pharmacist who, while continuing in business, makes any false representations to procure 1
453+registration for himself a license for the pharmacist or any other person, is guilty of a 2
454+Class 2 misdemeanor. 3
455+Section 29. That § 36-11-48 be AMENDED: 4
456+36-11-48. The State Board of Pharmacy board may suspend or revoke , in 5
457+accordance with chapter 1-26, any permit obtained pharmacy license issued under this 6
458+chapter on the following grounds: 7
459+(1) The license was obtained by false representations made in the application therefor, 8
460+or when the; 9
461+(2) The pharmacy for which the permit shall be license was issued is was kept open 10
462+for the transaction of business without a registered pharmacist in charge thereof, 11
463+or upon conviction; 12
464+(3) Conviction of a violation of any law of this state or of the United States pertaining 13
465+to the drug business or for the aiding or abetting in the violation of any such the 14
466+law; 15
467+(4) The active management of the pharmacy was changed without the transfer, as 16
468+provided in § 36-11-37, of the license; 17
469+(5) The location of the pharmacy was changed without the change being reported as 18
470+provided in § 36-11-39; 19
471+(6) The pharmacy was kept open for the transaction of business after the pharmacist 20
472+ceased to be in active management of the pharmacy; or 21
473+(7) The minimum requirements of this chapter and the board are no longer met . 22
474+A pharmacy license may not be suspended or revoked except by a vote of three or 23
475+more members of the board. 24
476+Section 30. That § 36-11-67 be AMENDED: 25
477+36-11-67. Pharmacists licensed under this chapter A pharmacist or physicians 26
478+physician licensed under chapter 36-4 who participate on participates in a drug utilization 27
479+review program as defined in § 36-11-2 are is not individually or jointly not subject to, 28
480+and are is immune from, claim, suit, liability, damages, or any other recourse, civil or 29
481+criminal, arising from any act or proceeding, decision, or determination undertaken, 30
482+performed, or reached in good faith and without malice when acting individually or jointly 31
483+in carrying out the responsibilities, authority, duties, powers, and privileges of the 32 25.365.18 15 1016
484+ Underscores indicate new language.
485+ Overstrikes indicate deleted language.
486+program conferred upon them under any provisions of law or rule, good faith being 1
487+presumed until proven otherwise, with malice required to be shown by the complainant. 2
488+For the purposes of this section, a "drug utilization review program" is a program 3
489+operated solely or partially as a professional standards review organization whose purpose 4
490+is to: 5
491+(1) Educate pharmacists and practitioners on: 6
492+(a) Severe adverse reactions to drugs; 7
493+(b) Therapeutic appropriateness; 8
494+(c) Overutilization; 9
495+(d) Underutilization; 10
496+(e) Appropriate use of generic products; 11
497+(f) Therapeutic duplication; 12
498+(g) Drug-disease contraindications; 13
499+(h) Drug-drug interactions; 14
500+(i) Incorrect drug dosage or duration of drug treatment; 15
501+(j) Drug-allergy interactions; and 16
502+(k) Clinical abuse or misuse; and 17
503+(2) Identify and reduce the frequency of patterns of potential and actual fraud, abuse, 18
504+gross overuse, inappropriate care, or medically unnecessary care associated with 19
505+specific drugs or groups of drugs among practitioners, pharmacists, and patients. 20
506+Section 31. That § 36-11-72 be AMENDED: 21
507+36-11-72. The board shall promulgate rules pursuant to chapter 1-26 to provide 22
508+for the regulation of telepharmacy in the this state. The rules shall include must provide 23
509+for: 24
510+(1) License and renewal application requirements, including establishment: 25
511+(a) Establishment of an annual initial license fee and a renewal fee, each not to 26
512+exceed two hundred fifty dollars; 27
513+(b) Procedures for the reinstatement of an expired license; and 28
514+(c) Establishment of a late fee for reinstating an expired license, not to exceed 29
515+fifty dollars; 30
516+(2) Minimum structural, security, and equipment requirements for the remote 31
517+pharmacy; 32
518+(3) Minimum staffing requirements for the central pharmacy and remote pharmacy; 33
519+(4) Record keeping requirements for the central pharmacy and remote pharmacy; 34 25.365.18 16 1016
520+ Underscores indicate new language.
521+ Overstrikes indicate deleted language.
522+(5) Establishment of policies Policies and procedures for the daily operation of the 1
523+remote pharmacy; and 2
524+(6) Use of automated dispensing machines. 3
525+Section 32. That a NEW SECTION be added to chapter 36-11: 4
526+If the majority of ownership of a remote pharmacy changes, the new owners must, 5
527+within thirty days after the ownership change: 6
528+(1) Submit the renewal application prescribed by the board, as provided in § 36-11-7
529+72, indicating the change of ownership; and 8
530+(2) Pay the renewal fee established by the board, as provided in § 36-11-72. 9
531+Section 33. That § 36-11A-8 be AMENDED: 10
532+36-11A-8. An applicant for licensure as a To apply for a wholesale or other drug 11
533+distributor shall apply annually to the board license, a person must submit an application 12
534+on a form provided by the board. The application shall be accompanied by a and pay an 13
535+annual license fee set by the board. The fee may not exceed two , not to exceed five 14
536+hundred fifty dollars. 15
537+All financial statements or related information submitted by applicants shall must 16
538+be treated as confidential materials. 17
539+Section 34. That § 36-11A-13 be AMENDED: 18
540+36-11A-13. Each wholesale drug distributor license expires on December thirty-19
541+first following the date of issue issuance. The board shall provide an application for license 20
542+renewal to each licensee before December first of each year. To renew a license, the 21
543+licensee shall submit the renewal application and pay the annual license fee set by the 22
544+board as provided in § 36-11A-8. If application for renewal of the license accompanied by 23
545+the annual license fee is not made before the expiration date, the existing license lapses 24
546+on the date of expiration. If the board receives a renewal application and fee for an expired 25
547+license, the board must assess a fifty-dollar late fee and may reinstate the license. 26
548+If the majority of ownership of a licensed facility changes, the new owners must, 27
549+within thirty days after the ownership change: 28
550+(1) Submit a renewal application, indicating the change of ownership; and 29
551+(2) Pay a fee equal to the annual license fee. 30
552+Section 35. That § 36-11-3 be REPEALED. 31 25.365.18 17 1016
553+ Underscores indicate new language.
554+ Overstrikes indicate deleted language.
555+Those registered pharmacists of this state electing to participate shall constitute 1
556+an association under the name and title of the South Dakota Pharmacists Association. The 2
557+purpose of the association is to serve as the state professional society of pharmacists 3
558+which represents the profession of pharmacy, enhances the public's awareness of 4
559+pharmacy, and serves the best interest of public health and pharmacy. The South Dakota 5
560+Pharmacists Association shall be conducted as a nonprofit corporation pursuant to the 6
561+terms of its articles of incorporation. The members of the association who have secured a 7
562+current annual certificate of registration to practice pharmacy in this state and who have 8
563+elected to participate in the association are entitled to all of the rights and privileges of 9
564+the association and may vote, serve as an officer or director of the association, and 10
565+participate in all of the meetings of the association. The association shall hold an annual 11
566+meeting at such time and place as it determines. 12
567+Section 36. That § 36-11-6 be REPEALED. 13
568+The board may, upon receipt, pay to the South Dakota Pharmacists Association 14
569+eighty percent of all fees the board receives for renewals of certificates of registration as 15
570+a pharmacist. The association shall use the funds for the following association activities to 16
571+benefit the public and the profession: continuing education, matters related to registration 17
572+standards for pharmacists, professional service standards, and general operating 18
573+expenses related to the activities enumerated in this section. The association shall also 19
574+use funds received to pay any legislated assessment to support a diversion program for 20
575+chemically impaired pharmacists. Expenditures of funds shall be approved by the 21
576+president and treasurer of the association. The association shall annually file in the office 22
577+of the board an itemized statement of the receipts of the association and disbursements 23
578+from the receipts. 24
579+Section 37. That § 36-11-17 be REPEALED. 25
580+Every person initially applying for a certificate of registration with the Board of 26
581+Pharmacy as a registered pharmacist shall pay to the board with the application a fee, not 27
582+to exceed thirty-five dollars, set by the board by rule promulgated pursuant to chapter 1-28
583+26. 29
584+Section 38. That § 36-11-18 be REPEALED. 30 25.365.18 18 1016
585+ Underscores indicate new language.
586+ Overstrikes indicate deleted language.
587+It shall be the duty of the Board of Pharmacy to examine all applications for 1
588+registration submitted in due form as provided in the rules and regulations of the board 2
589+and to grant certificates of registration to such persons as may be entitled to the same 3
590+under the provisions of this chapter. 4
591+Section 39. That § 36-11-22 be REPEALED. 5
592+The Board of Pharmacy shall keep a record of registration in which shall be entered 6
593+the names and places of business of all persons registered under this chapter which 7
594+records shall also specify such facts as such persons shall claim to justify their registration. 8
595+Section 40. That § 36-11-28 be REPEALED. 9
596+A certificate of registration as a pharmacist shall not be revoked or suspended 10
597+except after hearing before the Board of Pharmacy at which a majority of its members are 11
598+present and in compliance with chapter 1-26. 12
599+Section 41. That § 36-11-29 be REPEALED. 13
600+An appeal from the decision of the Board of Pharmacy may be taken as provided 14
601+by chapter 1-26. 15
602+Section 42. That § 36-11-40 be REPEALED. 16
603+Any permit issued under the provisions of § 36-11-32 shall be void if the active 17
604+management of any pharmacy is changed without the transfer, as provided in § 36-11-18
605+37, of the permit therefor, or if the location of said pharmacy is changed without the same 19
606+being reported as provided in § 36-11-39, or if the pharmacy is kept open for business 20
607+after the permittee has ceased to be in active management of said pharmacy, and 21
608+whenever the minimum requirements of this chapter and the Board of Pharmacy are no 22
609+longer met. 23
610+Section 43. That § 36-11-42 be REPEALED. 24
611+Any permit issued under the provisions of § 36-11-32 shall be void and subject to 25
612+cancellation by the State Board of Pharmacy, unless such pharmacy is maintained and 26
613+operated in a clean and sanitary condition, free from unhealthful, foreign, or injurious 27
614+contamination. 28 25.365.18 19 1016
615+ Underscores indicate new language.
616+ Overstrikes indicate deleted language.
617+Section 44. That § 36-11-49 be REPEALED. 1
618+Before any permit for a pharmacy shall be revoked chapter 1-26 shall be complied 2
619+with. Two members of the board shall constitute a quorum and no permit shall be revoked 3
620+except by a vote of two or more members of the State Board of Pharmacy. 4
621+Section 45. That § 36-11A-4.2 be REPEALED. 5
622+No outsourcing facility engaged in compounding of nonpatient specific sterile and 6
623+nonsterile drugs may become licensed by the board without first obtaining a registration 7
624+and inspection by the United States Food and Drug Administration, and paying the license 8
625+fee set by the board in rules promulgated pursuant to chapter 1-26. The fee may not 9
626+exceed two hundred dollars. 10
627+Section 46. No later than September 30, 2025, the Board of Pharmacy shall, pursuant to 11
628+chapter 1-26, provide for and file with the secretary of state, the amendment of ARSD 12
629+20:67:02:01, as set forth below: 13
630+ 20:67:02:01. Application and fee. A wholesale or other distributor must 14
631+apply each year to the board, electronically or on a form supplied by the secretary of the 15
632+board, for a license to engage in the distribution of prescription drugs. Each application 16
633+shall must be accompanied by a license fee of $200 five hundred dollars. 17
634+ Source: 18 SDR 95, effective November 25, 1991; 24 SDR 160, effective May 18
635+26, 1998; 45 SDR 86, effective December 24, 2018. 19
636+ General Authority: SDCL 36-11A-14(1),(6). 20
637+ Law Implemented: SDCL 36-11A-7, 36-11A-8. 21