reglab/statecodes huggingface dataset:
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:04 - Access to data

Current through Register Vol. 51, page 10, July 15, 2024
Healthcare practitioners authorized to prescribe or dispense
				  controlled substances may request on-line access to the data for the purpose of
				  providing patient health care. A healthcare practitioner authorized to
				  prescribe may designate one or more persons who are licensed or registered with
				  the respective regulatory board to serve as a delegate. Prior to being granted
				  access to program information, a practitioner or delegate shall submit a
				  request for registration and program access. The board will verify the
				  licensure status of the practitioner or delegate with the appropriate licensing
				  authority. In the case of integration, as defined in SDCL
				  34-20E-1(9), the
				  board may allow an entitys credentialing process to verify licensure status.
				  The program safeguards to protect the privacy of the data include a secure
				  login and password for the practitioners authorized to access the data.
The board shall conduct regular reviews of data access by
				  practitioners to identify possible violations of law or breach of professional
				  standards that may have occurred. Whenever such information is identified, the
				  board will notify the appropriate professional licensing, certification or
				  regulatory agency or entity, and provide information necessary for an
				  investigation.
General Authority:
SDCL
					 34-20E-20(4).
Law Implemented:
SDCL
					 34-20E-7(1),
					 34-20E-12,
					 34-20E-20(4).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:05 - Disclosure of data

Current through Register Vol. 51, page 10, July 15, 2024
Each request for information from the central repository
				  must be submitted on a form or electronic platform provided by the board and
				  may be mailed, faxed, or submitted electronically to the board office. The
				  information may be mailed, faxed or submitted electronically to the individual
				  requesting the profile, and marked "confidential".
A prescriber or dispenser may request patient information
				  electronically or in writing if the request:
(1) Is signed or submitted on an electronic
				platform by the prescriber, delegate, or dispenser requesting the information
				and includes the business name and address;
(2) Includes the patient's name, date of
				birth, purpose of the request, and the date range for the profile;
				and
(3) Includes a statement
				indicating a prescriber or a dispenser and patient relationship
				exists.
General Authority:
SDCL
					 34-20E-20(4).
Law Implemented:
SDCL
					 34-20E-5,
					 34-20E-7(1).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:06 - Disclosure of data - Individual

Current through Register Vol. 51, page 10, July 15, 2024
An individual or the individual's agent, authorized in
				  writing, may request prescription information of the individual or the
				  individual's minor child.
The individual requesting the prescription information or an
				  authorized agent of the individual shall submit a signed, written request on a
				  form provided by the board for records of the individual's prescriptions
				  reported to the program.
The individual or agent will be required to present a current
				  government-issued photo identification at the time of delivery of the
				  request.
An individual who is unable to personally deliver the request
				  to the board office may submit a request by mail or a commercial delivery
				  service. The request shall comply with the provisions above, a copy of the
				  current government issued photo identification shall be enclosed, and the
				  signature of the requesting individual shall be notarized.
General Authority:
SDCL
					 34-20E-20.
Law Implemented:
SDCL
					 34-20E-7(2),
					 34-20E-20(4).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:07 - Disclosure of data Regulatory board

Current through Register Vol. 51, page 10, July 15, 2024
A state board or regulatory agency with appropriate
				  authority may request information electronically or in writing.
The request shall include a statement of its purpose and
				  authority, the name and license number of the individual, the date range
				  requested, and the specific reasons for the request.
The request shall be signed or submitted electronically by
				  the authorized agent and include the mailing address for the board or
				  agency.
General Authority:
SDCL
					 34-20E-20.
Law Implemented:
SDCL
					 34-20E-7(3),
					 34-20E-20(4).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:08 - Disclosure of data - Law enforcement

Current through Register Vol. 51, page 10, July 15, 2024
A local, state, and federal law enforcement or prosecutorial
				  official engaged in the enforcement of laws related to controlled substances
				  may request information for the purpose of an investigation or prosecution of
				  the drug-related activity or probation or parole compliance of an individual.
				  The board shall verify the status of the law enforcement or prosecutorial
				  official with the appropriate authority.
The electronic or written request shall include the
				  individual's name and date of birth, the date range requested, and the specific
				  reasons for the request, that must be approved by the board prior to the
				  release of the information.
The request shall be signed by the authorized official and
				  include that person's mailing address.
General Authority:
SDCL
					 34-20E-20(4).
Law Implemented:
SDCL
					 34-20E-7(4),
					 34-20E-20(4).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:09 - Disclosure of data - Court orders

Current through Register Vol. 51, page 10, July 15, 2024
The board shall provide program information in response to
				  court orders and warrants. The board shall provide program information in
				  response to court issued subpoenas.
General Authority:
SDCL
					 34-20E-20(4).
Law Implemented:
SDCL
					 34-20E-7(7),
					 34-20E-20(4).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:10 - Disclosure of data - Other entities

Current through Register Vol. 51, page 10, July 15, 2024
Other designated entities may request profiles or
				  information as identified in SDCL
				  34-20E-7.
The request shall include the date range requested, the
				  specific reasons for the request, and the individual's name and birth date if
				  applicable.
The request shall be signed by the authorized individual and
				  include that person's mailing address.
General Authority:
SDCL
					 34-20E-20(4).
Law Implemented:
SDCL
					 34-20E-7(5)(6)(8) and
					 (9).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:11 - Data retention

Current through Register Vol. 51, page 10, July 15, 2024
All dispenser records of prescriptions reported to the
				  program shall be retained by the board for a period of three years following
				  the date of the record. All records of access to or query of program
				  information shall be retained by the board for a period of three years
				  following the date of the record. At least semiannually, all program
				  information identified as exceeding that three-year period shall be deleted
				  from the program and discarded in a manner to maintain the confidentiality of
				  the program information and data. Statistical data and reports from which all
				  personally identifiable information has been removed or which do not contain
				  personally identifiable information may be retained by the board for historical
				  purposes.
Declaratory Ruling:
A health care provider
					 licensed under SDCL chapter 36-4 A engages during the course of employment in
					 exposure-prone invasive procedures. The situation is not an emergency in which
					 the patient's life or limb is in danger. The licensee knows or has reason to
					 know that the licensee is a carrier of the human immunodeficiency virus (HIV)
					 or the hepatitis B virus (HBV) but does not follow universal precautions set
					 out by the Centers for Disease Control and Prevention (CDC). Because of
					 reporting requirements for communicable diseases, the Department of Health
					 discovers that the licensee is a carrier of HIV or HBV and notifies a review
					 panel pursuant to §
											44:20:02:08(2).
					 (Note: Effective January 26, 1995, all health professionals were required by
					 the Department of Health in § 44:20:04:01 to comply with universal
					 precautions of the CDC.)
The universal precautions of the CDC are a minimum standard
					 of care. The following actions are considered unprofessional conduct under SDCL
					 36-4A-38 and grounds for
					 discipline:
(1) Failure to comply with universal precautions;
(2) Performance of invasive procedures when infected with
					 HIV or HBV without first seeking counsel from an expert review panel; and
(3) Failure to comply with the recommendations of an expert
					 review panel.
Declaratory Ruling of the Board of Medical and Osteopathic
					 Examiners dated September 21, 1994.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:01 - Applicability

Current through Register Vol. 51, page 10, July 15, 2024
The following procedure applies to complaints about holders
				  of the licenses, permits, registrations, or certificates regulated by the Board
				  of Pharmacy.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and
					 (13).
Law Implemented:
SDCL
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:02 - Complaints

Current through Register Vol. 51, page 10, July 15, 2024
The executive secretary may initiate an investigation based
				  on a written complaint. Any person filing a complaint shall submit the
				  complaint in writing to the executive secretary. A complaint is not a public
				  record. The executive secretary shall dismiss any complaint that concerns
				  matters over which the board does not have jurisdiction, and shall notify the
				  complainant of that action. The executive secretary may also initiate an
				  investigation upon reasonable suspicion that a licensee or registrant is in
				  violation of any applicable standard for professional
				  conduct.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:03 - Investigations

Current through Register Vol. 51, page 10, July 15, 2024
The executive secretary shall initiate an investigation of a
				  complaint by notifying the license, registration, or certificate holder of the
				  complaint and obtaining a response to the complaint. If the executive secretary
				  determines that the complaint concerns compliance with licensing standards and
				  requirements, the executive shall investigate the complaint. The notice shall
				  be in writing and shall include a statement that the licensure, licensee, or
				  registrant is entitled to due process rights, including the right to notice and
				  an opportunity to be heard and to be represented by counsel. The executive
				  secretary may appoint a board member to assist in the
				  investigation.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-1,
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:04 - Completion of complaint investigation

Current through Register Vol. 51, page 10, July 15, 2024
Upon completion of a complaint investigation, the executive
				  secretary may:
(1) Dismiss the
				complaint as unsubstantiated or requiring no further action. Dismissal of a
				complaint is not a public record;
(2) Issue a letter of concern, that shall be
				placed in the licensees or registrant's permanent records. A letter of concern
				is not a public record;
(3)
				Recommend the board issue the licensee or registrant a public
				reprimand;
(4) Recommend the board
				re-open and modify the license to include compliance with specified terms and
				conditions; or
(5) Recommend the
				board suspend or revoke the license.
If the executive secretary recommends issuance of a public
				  reprimand, re-opening and modification, or suspension or revocation of the
				  license, registration, or certificate held by the licensee or registrant, the
				  executive secretary shall notify the licensee or registrant of the right to
				  contest the recommendation. If contested, the executive secretary shall issue a
				  petition for hearing that sets out the recommendation and the reasons for the
				  recommendation and initiates a contested case hearing. A copy of the petition
				  for hearing shall be sent to the licensee or registrant. The executive
				  secretary and licensee or registrant may enter into a settlement agreement
				  concerning the recommendation to be made to the board.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:05 - Status of complainant

Current through Register Vol. 51, page 10, July 15, 2024
The complainant is not a party to any contested case hearing
				  resulting from the executive secretary's investigation of a complaint, although
				  the complainant may be called as a witness in the hearing. The executive
				  secretary shall notify a complainant of any public final agency action taken as
				  a result of a complaint.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:33 - COMPLAINT PROCEDURES › Section 20:51:33:06 - Effect of failure to renew during investigation

Current through Register Vol. 51, page 10, July 15, 2024
The holder of a license, registration, or certificate may
				  choose not to renew the license, registration, or certificate after a complaint
				  investigation has been initiated by the executive secretary. A failure to renew
				  after an investigation has been initiated shall be reported as "withdrawn under
				  investigation" in the board's permanent license files and in any national
				  databases to which the board is required to report licensure action.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and
					 (13).
Law Implemented
SDCL
					 36-11-1,
					 36-11-13,
					 36-11-15,
					 36-11-16.1,
					 36-11-19.4,
					 36-11-19.6,
					 36-11-20,
					 36-11-23.3,
					 36-11-26,
					 36-11-28,
					 36-11-29,
					 36-11-30,
					 36-11-31, 36-11-4436-11-46,
					 36-11-48, 36-11-49, 36-11-65, 36-11A-14.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:01 - Applicability

Current through Register Vol. 51, page 10, July 15, 2024
The following procedure applies to contested case
				  proceedings for license, registration, or certificate applications and to
				  disciplinary proceedings before the Board of Pharmacy.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:02 - Petitions for hearing

Current through Register Vol. 51, page 10, July 15, 2024
An applicant for a license, registration, or certificate
				  issued by the board may file a petition for hearing at any time during the
				  processing of an application. The executive secretary may file a petition for
				  hearing to initiate a disciplinary proceeding against a licensee or registrant.
				  A petition for hearing shall be signed by the petitioner and contain the
				  following information: the name and address of the applicant, licensee, or
				  registrant; the basis for the request for hearing; recitation of the applicable
				  statutes or regulations under which the petitioner is requesting board action;
				  and the relief requested by the petitioner.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:03 - Filing of petitions for hearing

Current through Register Vol. 51, page 10, July 15, 2024
All petitions for hearing shall be filed with the executive
				  secretary, who shall maintain the record of contested case proceedings held
				  before the board.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:04 - Scheduling of hearing

Current through Register Vol. 51, page 10, July 15, 2024
Upon receipt of a petition for hearing, the board president
				  may appoint an examiner to conduct the contested case hearing, or may schedule
				  the contested case hearing before the board, as authorized by applicable
				  statutes.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:05 - Hearing procedure

Current through Register Vol. 51, page 10, July 15, 2024
Contested case hearings shall be conducted in accordance
				  with SDCL 1-26. The parties to a hearing are the executive secretary and the
				  applicant, licensee or registrant. A board member who has participated in any
				  investigation of the matter before the board shall be disqualified from all
				  deliberations and decisions.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:06 - Final board decision

Current through Register Vol. 51, page 10, July 15, 2024
If the board hears the proceeding, the board shall issue a
				  final decision and require the parties to submit proposed findings of fact and
				  conclusions of law for consideration at the board's next meeting. If a hearing
				  examiner hears the proceeding, the examiner shall issue a proposed decision
				  including findings of fact and conclusions of law. The examiner shall serve the
				  proposed decision upon the board and the parties. The board may request that
				  the parties appear before the board to present oral arguments and objections to
				  the examiner's proposed decision. The board shall issue a final decision and
				  accept, reject, or modify the findings, conclusions, and decisions of the
				  examiner.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:07 - Notice of decision

Current through Register Vol. 51, page 10, July 15, 2024
The board shall issue a notice of decision, accompanied by
				  the final board decision and findings of fact and conclusions of law, to the
				  applicant, licensee, or registrant and executive secretary.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:08 - Assessment of costs of disciplinary hearings

Current through Register Vol. 51, page 10, July 15, 2024
The board may assess the costs associated with a contested
				  case proceeding resulting in disciplinary action, against a licensee or
				  registrant upon motion by the executive secretary. If requesting the assessment
				  of costs, the executive secretary shall present a statement of costs to the
				  board or hearing examiner at the time the board of hearing examiner submits
				  proposed findings of fact and conclusions of law.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-14,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:09 - Board member conflict of interest

Current through Register Vol. 51, page 10, July 15, 2024
A board member who may not participate in a contested case
				  proceeding or disciplinary action if the board member:
(1) Is personally related to a party involved
				in the contested case proceeding or disciplinary action by two degrees of
				consanguinity;
(2) Has a direct
				financial interest in a party involved in the contested case proceeding or
				disciplinary action through employment or by contract;
(3) Directly supervises and is responsible
				for peer review of a party involved in the contested case proceeding or
				disciplinary action; or
(4) Has a
				spouse who has a direct financial interest in or directly contracts with a
				party involved in the contested case proceeding or disciplinary action. If a
				conflict of interest exists, the member shall make an oral statement of recusal
				on the record at the initiation of the hearing.
A recused member may not participate in board discussions or
				  decision-making regarding that contested case proceeding or disciplinary
				  action.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-14,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:34 - CONTESTED CASE HEARING PROCEDURES › Section 20:51:34:10 - Board member potential conflict of interest

Current through Register Vol. 51, page 10, July 15, 2024
A potential conflict of interest is an indirect financial
				  interest, or a personal relationship or another interest in a party involved in
				  a contested case proceeding or disciplinary action that is different from that
				  of the general public, and that a reasonable person would believe might result
				  in bias or prejudgment. A board member shall disclose any potential conflict of
				  interest in a contested case proceeding or disciplinary action on the record at
				  the initiation of the hearing, or during the hearing, if the board member
				  becomes aware of the existence of a potential conflict of interest at that
				  time. Upon the board's own motion or the motion of a party, and considering the
				  rule of necessity if maintenance of a quorum is an issue, the board may recuse
				  a member with a potential conflict of interest if the board determines that the
				  potential conflict of interest raises an unacceptable risk of bias or
				  prejudgment in the contested case proceeding or disciplinary
				  action.
General Authority:
SDCL
					 36-11-11(1)(2)(3)(10)and(13).
Law Implemented:
SDCL
					 36-11-28,
					 36-11A-14,
					 36-11A-45.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:01 - Definitions

Current through Register Vol. 51, page 10, July 15, 2024
Terms used in this chapter:
(1) "Controlled substance" means a drug as
				defined in SDCL §§34-20B-11 to 34-20B-26;
(2) "Donor" means any person, including an
				individual member of the public, or any entity legally authorized to possess
				drugs with a license or permit in good standing in the state in which it is
				located, including but not limited to a wholesaler or distributor, third party
				logistic providers, pharmacy, dispenser, clinic, surgical or health center,
				laboratory, medical or pharmacy school, prescriber or other health care
				professional, or healthcare facility. Donor shall also mean government agencies
				and entities that are federally authorized to possess drugs including but not
				limited to drug manufacturers, repackagers, relabelers, outsourcing facilities,
				and federal healthcare facilities;
(3) " Drugs" means prescription drugs as
				defined in SDCL chapter 36-11-2.1;
(4) "Eligible patient" means an indigent,
				uninsured, or underinsured person; provided, however, that if the participating
				pharmacy's supply of donated drugs exceed the need for donated drugs by
				indigent patients, then any other person in need of a particular drug can be an
				eligible patient;
(5) "Healthcare
				facility" means:
(a) A facility licensed
				pursuant to SDCL chapter 34-12; or
(b) A similar licensed facility located in
				another state;
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:02 - Eligibility criteria

Current through Register Vol. 51, page 10, July 15, 2024
Participation in the donated prescription drug repository
				  program is voluntary. A participating pharmacy electing to participate in the
				  program must:
(1) Be in compliance
				with all applicable federal and state laws and shall hold an active,
				nonrestricted, board issued license in good standing;
(2) Submit on a form provided by the board
				the following:
(a) The pharmacy name, street
				address, telephone number, and board issued license number;
(b) The name and license number of the
				pharmacist-in-charge (PIC) as defined by ARSD 20:51:06:02.01; and
(c) A statement, signed and dated by the PIC
				indicating that the pharmacy meets the eligibility requirements under this rule
				and all pharmacists shall comply with the requirements of this chapter.
A pharmacy may withdraw from participation in the program at
				  any time by providing written notice to the board on a form prescribed by the
				  board.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:03 - Criteria for accepting donated prescription drugs and supplies

Current through Register Vol. 51, page 10, July 15, 2024
Participating pharmacies shall only accept the following
				  donations:
(1) A donor who is 18 years
				of age or older may donate legally obtained prescriptions drugs or supplies to
				a participating pharmacy if they meet the requirements of this rule as
				determined by the PIC;
(2) The
				participating pharmacy may accept a prescription drug only if all of the
				following requirements are met:
(a) The drug
				is in its original sealed and tamper-evident packaging. However, a drug in a
				single-unit dose or blister pack with the outside packaging opened may be
				accepted if the single-unit package is not opened;
(b) The packaging contains the lot number and
				expiration date of the drug. If the lot number is not retrievable, all
				specified medications will be destroyed in the event of a recall;
(c) The drug has an expiration date that is
				more than six months after the date that the drug was donated. A donated
				prescription drug bearing an expiration date that is six months or less after
				the date the prescription drug was donated, may be accepted and distributed if
				the drug is in high demand and can be dispensed for use prior to the drug's
				expiration date;
(d) Neither the
				drug nor the packaging has any physical signs of tampering, misbranding,
				deterioration or adulteration, and there is no reason to believe that the drug
				is adulterated;
(e) All donated
				eligible drugs received by the participating pharmacy shall be documented in
				the board's electronic database of drugs and supplies and shall be accompanied
				by a donor form with an agreement to donate; and
(f) If the drug has not been continually
				under the control of a health care professional, a pharmacy, or other legally
				authorized entity allowed to possess prescription drugs, the participating
				pharmacy must collect a donation form that is signed by the donor or that
				person's authorized representative attesting to proper
				storage.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:04 - Drugs which may not be donated or accepted

Current through Register Vol. 51, page 10, July 15, 2024
In addition to the prohibitions in SDCL
				  34-20G-2, no drug that requires
				  storage temperatures other than normal room temperature as specified by the
				  manufacturer may be donated or accepted because of the increased potential for
				  these drugs to become adulterated. Excluded from this restriction are drugs
				  donated directly from a drug manufacturer or other entity authorized to possess
				  prescription drugs.
General Authority:
SDCL
					 34-20H-7(2)(3).
Law Implemented:
SDCL
					 34-20H-2,
					 34-20H-7(2)(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:05 - Criteria for inspecting donated prescription drugs and supplies

Current through Register Vol. 51, page 10, July 15, 2024
A PIC designated pharmacist at the participating pharmacy
				  shall inspect donated prescription drugs and supplies to determine, to the
				  extent reasonably possible in the judgment of the pharmacist, that the drugs
				  and supplies are not adulterated or misbranded, are safe and suitable for
				  dispensing, and are not ineligible drugs or supplies. The pharmacist who
				  inspects the drugs shall sign the donor form stating the above. If a
				  participating pharmacy receives drugs and supplies from another participating
				  pharmacy, the receiving participating pharmacy does not need to reinspect the
				  drugs and supplies when receiving a copy of the donor form with the inspection
				  information. The transfer of the medications from one participating pharmacy to
				  another shall be documented in both the receiving and the donating
				  pharmacy.
General Authority:
SDCL
					 34-20H-7(2)(3).
Law Implemented:
SDCL
					 34-20H-2,
					 34-20H-7(2)(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:06 - Storage of donated prescription drugs and supplies

Current through Register Vol. 51, page 10, July 15, 2024
The participating pharmacy shall store donated drugs and
				  supplies in a storage area under environmental conditions appropriate for the
				  drugs or supplies being stored. Donated drugs and supplies may not be stored
				  with nondonated inventory.
When donated drugs are not inspected immediately upon
				  receipt, a participating pharmacy shall quarantine the donated drugs until the
				  donated drugs have been inspected and approved for dispensing under the
				  program.
Participating pharmacies shall destroy donated drugs that are
				  not suitable for dispensing and make a record of the destruction.
General Authority:
SDCL
					 34-20H-7(2)(3).
Law Implemented:
SDCL
					 34-20H-3,
					 34-20H-7(2)(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:07 - Return of donated controlled substances

Current through Register Vol. 51, page 10, July 15, 2024
Controlled substances shall not be accepted for donation.
				  Controlled substances submitted for donation shall be returned immediately to
				  the donor or the donor's representative who provided the drugs. In the event
				  that controlled substances enter the participating pharmacy and it is not
				  possible or practicable to return the controlled substances to the donor or the
				  donor's representative due to inability to identify the donor or the donor's
				  representative or due to refusal by the donor or the donor's representative to
				  receive them, abandoned controlled substances shall be documented and destroyed
				  rendering the chemical compound of the drug to be nonretrievable per
				  21 CFR §
										1300.05(b). Such destruction
				  shall be performed by a pharmacist or other person with authority to dispense
				  controlled substances and shall be witnessed by another employee of the
				  participating pharmacy.
General Authority:
SDCL
					 34-20H-2,
					 34-20H-3,
					 34-20H-7(2)(3).
Law Implemented:
SDCL
					 34-20H-2,
					 34-20H-3,
					 34-20H-7(2)(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:08 - Recalls

Current through Register Vol. 51, page 10, July 15, 2024
If a participating pharmacy receives a recall notification,
				  the pharmacy shall perform a uniform destruction of all of the recalled
				  prescription drugs and complete the destruction information form for all
				  donated drugs destroyed. If a recalled drug has been dispensed, the
				  participating pharmacy shall immediately notify the recipient of the recalled
				  drug pursuant to established drug recall pharmacy procedures.
General Authority:
SDCL
					 34-20H-3,
					 34-20H-7(2)(3).
Law Implemented:
SDCL
					 34-20H-3,
					 34-20H-7(2)(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:09 - Criteria for dispensing donated prescription drugs and supplies

Current through Register Vol. 51, page 10, July 15, 2024
Donated drugs and supplies may be dispensed only if the drugs
				  or supplies are prescribed by a health care practitioner for use by an eligible
				  individual and are dispensed by a licensed pharmacist.
(1) A participating pharmacy shall prioritize
				dispensing to an individual requesting drugs through the program as follows:
(a) An indigent individual;
(b) An individual who has no active
				third-party prescription drug reimbursement coverage for the drug prescribed;
				and
(c) Any other
				individual.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:10 - Eligibility criteria for individuals to receive donated prescription drugs and supplies

Current through Register Vol. 51, page 10, July 15, 2024
An individual who requests and receives drugs from the
				  donated prescription drug repository program shall sign an acceptance form
				  attesting to the following:
(1) The
				individual meets the definition of eligible patient in §
				20:51:35:1(4);
(2) The individual
				acknowledges that the drugs have been donated; and
(3) The individual consents to a waiver of
				the requirement for child resistant packaging of the Poison Prevention
				Packaging Act.
General Authority:
SDCL
					 34-20H-7(1).
Law Implemented:
SDCL
					 34-20H-7(1)(a),(b).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:35 - Donated Drug Repository Program › Section 20:51:35:11 - Handling fee

Current through Register Vol. 51, page 10, July 15, 2024
A participating pharmacy may charge the recipient of a
				  donated drug a handling fee, not to exceed a maximum of $25 to cover mailing,
				  handling, or dispensing costs. A prescription drug dispensed through the
				  prescription drug donation repository program shall not be eligible for
				  reimbursement under any insurance or medical assistance program.
General Authority:
SDCL
					 34-20H-7(4).
Law Implemented:
SDCL
					 34-20H-6,
					 34-20H-7(4)(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:01 - Definitions

Current through Register Vol. 51, page 10, July 15, 2024
Terms used in this chapter mean:
(1) "Central fill pharmacy," a pharmacy under
				the same ownership as the originating pharmacy or contracted to provide
				prescription filling or processing on behalf of the originating pharmacy;
				and
(2) "Originating pharmacy," a
				pharmacy that receives prescription drug orders from a patient, an agent of the
				patient, or a prescriber, and outsources the filling or processing of the order
				to a central fill pharmacy that dispenses the prescription to the patient or
				agent of the patient.
General Authority:
SDCL
					 36-11-11(1)(3).
Law Implemented:
SDCL
					 36-11-2.2,
					 36-11-19.1.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:02 - License required

Current through Register Vol. 51, page 10, July 15, 2024
Any pharmacy acting as a central fill pharmacy in this state
				  must be permitted pursuant to SDCL
				  36-11-32 and not permitted as a
				  pharmacy under SDCL
				  36-11-33. Any central fill
				  pharmacy located outside the state must be licensed as a non-resident pharmacy.
				  Any originating pharmacy located in this state must be permitted as a full-time
				  pharmacy.
General Authority:
SDCL
					 36-11-11(1)(3).
Law Implemented:
SDCL
					 36-11-19.2,
					 36-11-19.3,
					 36-11-30.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:03 - Requirements for central fill

Current through Register Vol. 51, page 10, July 15, 2024
The originating pharmacy and central fill pharmacy
				  must:
(1) Be under the same ownership
				or have a signed legal contract to provide central fill services;
(2) Share a common prescription software
				platform, as described in §
									20:51:20:04;
(3) Ensure a pharmacist, from either
				pharmacy, performs a prospective drug utilization review in accordance with
				§
									20:51:25:02 before dispensing any
				prescription. The identity of the pharmacist must be available to both
				pharmacies in the prescription record; and
(4) Have a policy and procedure, approved by
				both pharmacies, that outlines each pharmacy's role in the transaction and
				ensures patient safety and privacy.
General Authority:
SDCL
					 36-11-11(1)(3)(12).
Law Implemented:
SDCL
					 36-11-2.2,
					 36-11-68,
					 36-11-69.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:04 - Label requirements

Current through Register Vol. 51, page 10, July 15, 2024
The label for prescriptions filled by a central fill pharmacy
				  must meet the requirements in §§
									20:51:05:21 and
				  44:58:08:20 and must indicate that
				  the prescription was filled at a central fill pharmacy. The label must contain
				  the name, address, and phone number of the originating
				  pharmacy.
General Authority:
SDCL
					 36-11-11(1)(3).
Law Implemented:
SDCL
					 36-11-2.2(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:05 - Patient notification

Current through Register Vol. 51, page 10, July 15, 2024
The originating pharmacy must post a sign to provide notice
				  to patients that the pharmacy utilizes a central fill pharmacy
				  service.
General Authority:
SDCL
					 36-11-11(1)(3).
Law Implemented:
SDCL
					 36-11-36.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:36 - Central fill pharmacies › Section 20:51:36:06 - Patient requests

Current through Register Vol. 51, page 10, July 15, 2024
A patient may request not to utilize central fill pharmacy
				  service. The pharmacy must comply with the request.
General Authority:
SDCL
					 36-11-11(1)(3).
Law Implemented:
SDCL
					 36-11-36.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:47:02 - ETHICS › Section 20:52:02:02 - Violations

Current through Register Vol. 51, page 10, July 15, 2024
A violation of any of the ethical standards and conduct are
				  considered unprofessional conduct as defined by SDCL
				  36-4A-37.
General Authority:
SDCL
					 36-4A-42
Law implemented:
SDCL
					 36-4A-37
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:47:02 - ETHICS › Section 20:52:02:03 - Ethical considerations

Current through Register Vol. 51, page 10, July 15, 2024
The board may utilize the annotations and opinions included
				  in the guidelines for ethical conduct for the physician assistant profession,
				  2013 edition as guidance in determining whether a licensee has violated
				  professional ethical standards and conduct.
General Authority:
SDCL
					 36-4A-42
Law implemented:
SDCL
					 36-4A-37
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:01 - Application for physician assistant license

Current through Register Vol. 51, page 10, July 15, 2024
An applicant for a license as a physician assistant shall
				  file an application on forms approved by the board. The board may require a
				  personal interview at the time of application.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-8.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:03 - Physician assistant practice agreement

Current through Register Vol. 51, page 10, July 15, 2024
A licensed physician assistant shall have a practice
				  agreement with a supervising physician. The practice agreement shall be
				  submitted on a form approved by the board that describes the scope of practice
				  of the physician assistant, any practice location, the plan for physician
				  supervision, and other such information as may be required by the
				  board.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-1.1.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:03.01 - Supervision of a licensed physician assistant

Current through Register Vol. 51, page 10, July 15, 2024
A licensed physician assistant shall be supervised by a
				  physician licensed pursuant to SDCL chapter 36-4. The supervising physician
				  shall be available for consultation with the physician assistant at all times
				  while the physician assistant is involved in patient care. The supervising
				  physician and physician assistant shall meet to discuss patient care and review
				  the physician assistant practice. The supervision plan shall be outlined in the
				  practice agreement and approved by the board.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-29.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:03.02

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-29.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:05 - Termination of physician assistant practice agreement

Current through Register Vol. 51, page 10, July 15, 2024
A physician assistant shall notify the board, in writing, of
				  the termination of a practice agreement. A physician assistant may not practice
				  without a practice agreement approved by the board.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-1.1.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:09 - Renewal of physician assistant license

Current through Register Vol. 51, page 10, July 15, 2024
An application for annual renewal, as provided in SDCL
				  36-4A-31 and SDCL
				  36-4A-32, shall be filed with the
				  board before the first day of May of each year. The annual renewal fee shall be
				  submitted with the annual renewal application.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-31.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:52 - PHYSICIAN'S ASSISTANTS › Chapter 20:52:01 - Physician assistant license › Section 20:52:01:11 - Fee amounts

Current through Register Vol. 51, page 10, July 15, 2024
The fees for physician assistants are as follows:
(1) Initial licensure application,
				$75;
(2) Annual renewal,
				$100;
(3) Reinstatement of lapsed
				license, $125;
(4) Temporary
				license, $50.
General Authority:
SDCL
					 36-4A-42.
Law Implemented:
SDCL
					 36-4A-34.