reglab/statecodes huggingface dataset:
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:19 - Ratio

Current through Register Vol. 51, page 10, July 15, 2024
Up to three pharmacy technicians may be on duty in a pharmacy
				  for every pharmacist on duty. A pharmacy intern does not count in this
				  ratio.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26).
Number of interns, §
											20:51:02:11.01.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:19.01 - Exception to ratio for mail service pharmacy

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-11(1)(14).
Law Implemented:
SDCL
					 36-11-11(14).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:20 - Delegation and supervision of technical functions

Current through Register Vol. 51, page 10, July 15, 2024
A pharmacist may delegate technical dispensing functions to a
				  pharmacy technician provided the pharmacist is on site supervising the
				  performance of the delegated functions. The pharmacist shall provide and
				  document the final verification for the accuracy, validity, completeness, and
				  appropriateness of the patient's prescription or medication order prior to the
				  delivery of the medication to the patient or the patient's
				  representative.
The physical presence requirement of the pharmacist does not
				  apply when utilizing an automated mechanical distribution device. The
				  technician may place medications into the automated mechanical distribution
				  device that have been checked by the pharmacist. The pharmacist is not required
				  to accompany the technician when placing medications into the automated
				  mechanical distribution device. The automated mechanical distribution device
				  must be capable of printing out a record of medications filled by the
				  technician. The record must be checked and verified by the pharmacist
				  daily.
General Authority:
SDCL
					 36-11-11(1)(5)(13).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-44.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:21 - Technical functions

Current through Register Vol. 51, page 10, July 15, 2024
At the discretion of the supervising pharmacist, technical
				  functions that may be delegated to a pharmacy technician include:
(1) Performing packaging, manipulative, or
				repetitive tasks relating to the processing of a prescription or medication
				order in a licensed pharmacy;
(2)
				Accepting prescription refill authorization communicated to a pharmacy by a
				prescriber, or by the prescriber's agent. Any changes other than the number of
				refills on the prescription may not be accepted by a technician and must be
				accepted by a pharmacist or pharmacy intern;
(3) Contacting prescribers to obtain
				prescription refill authorization;
(4) Collecting pertinent patient
				information;
(5) Inspecting drug
				supplies provided and controlled by a South Dakota licensed pharmacy, including
				drug supplies maintained in an automated mechanical distribution device,
				emergency medical room, ambulance, long-term care facility, hospital nursing
				unit, or hospice facility; and
(6)
				Assisting the pharmacist with the preparation of medications for administration
				to the patient topically, by injection, or by other approved methods.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:22 - Tasks a pharmacy technician may not perform

Current through Register Vol. 51, page 10, July 15, 2024
A pharmacy technician may not:
(1) Provide the final verification for the
				accuracy, validity, completeness, or appropriateness of a filled prescription
				or medication order;
(2) Conduct
				prospective drug use review or evaluate a patient's medication record for
				purposes identified in §
									20:51:25:02;
(3) Provide final verification of automated
				dispensing medication fill records for accuracy and completeness;
(4) Make decisions that require a
				pharmacist's professional judgment such as interpreting new orders, applying
				information, or making product selection for drugs that are
				substitutable;
(5) Accept new
				verbal prescription medication orders communicated to the pharmacy by a
				prescriber or the prescriber's agent; or
(6) Provide pharmaceutical services in a
				pharmacy without a pharmacist being present, except as authorized in chapter
				20:51:30.
A violation of this section may be grounds for disciplinary
				  action as provided in §
										20:51:29:27.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-26.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:23 - Misrepresentative deeds

Current through Register Vol. 51, page 10, July 15, 2024
A pharmacy technician may not make any statement tending to
				  deceive, misrepresent, or mislead anyone, or be a party to or an accessory to
				  any fraudulent or deceitful practice or transaction in a
				  pharmacy.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:24 - Confidentiality

Current through Register Vol. 51, page 10, July 15, 2024
In the absence of express written consent from the patient or
				  a written order or direction of a court, except where the best interests of the
				  patient require, a pharmacy technician may not divulge or reveal to any person
				  other than as outlined in SDCL
				  36-11-69, any of the following
				  information:
(1) The contents of any
				prescription drug order or medication, the therapeutic effect thereof, or the
				nature of professional pharmaceutical services rendered to the
				patient;
(2) The nature, extent, or
				degree of illness suffered by the patient; or
(3) Any medical information furnished by the
				prescriber.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-69.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:25 - Illegal or unethical behavior

Current through Register Vol. 51, page 10, July 15, 2024
A pharmacy technician may not exhibit illegal or unethical
				  behavior in connection with the technician's pharmacy employment. Illegal or
				  unethical behavior includes: verbal or physical abuse, coercion, intimidation,
				  harassment, sexual advances, threats, degradation of character, profanity,
				  indecent or obscene conduct, and theft. A violation of this section may be
				  grounds for disciplinary action as provided for in §
									20:51:29:27.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-26.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:26 - Denial of registration

Current through Register Vol. 51, page 10, July 15, 2024
The board may deny an application for registration as a
				  pharmacy technician for any violation of:
(1) The laws of this state, another state, or
				the United States, relating to prescription drugs, controlled substances, or
				nonprescription drugs; or
(2) This
				chapter.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-26.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:29 - Registered pharmacy technicians › Section 20:51:29:27 - Disciplinary actions

Current through Register Vol. 51, page 10, July 15, 2024
For violations of this chapter, the board may:
(1) Revoke a pharmacy technician
				registration;
(2) Suspend a
				pharmacy technician registration until further order of the board or for a
				specified period;
(3) Not renew a
				pharmacy technician registration;
(4) Prohibit permanently, until further order
				of the board, or for a specified period, the engaging in specified procedures,
				methods, or acts;
(5) Impose a
				probationary period;
(6) Refer the
				pharmacy technician to the Health Professionals' Assistance Program;
				or
(7) Issue a letter of concern or
				public reprimand.
General Authority:
SDCL
					 36-11-11(1)(13).
Law Implemented:
SDCL
					 36-2A-2,
					 36-2A-6,
					 36-11-2(26),
					 36-11-26.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:01 - Definitions

Current through Register Vol. 51, page 10, July 15, 2024
Terms defined in SDCL
				  36-11-71 have the same meaning
				  when used in this chapter.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72.
Law Implemented:
SDCL
					 36-11-71.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:02 - Application for remote pharmacy site

Current through Register Vol. 51, page 10, July 15, 2024
No remote pharmacy may be established, operated, or
				  maintained unless the board issues a license. An application for licensure to
				  establish, operate, or maintain a remote pharmacy shall be made on a form
				  provided by the board. The applicant shall submit an initial license fee of
				  $200 and provide a set of blueprints and documentation showing that all
				  requirements of this chapter have been met. The applicant shall demonstrate to
				  the board that there is limited or no access to pharmacy services in the
				  community. When considering whether to approve an application, the board shall
				  consider the needs of the community. The board shall approve or disapprove an
				  application within 60 days of receipt.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(1).
Law Implemented:
SDCL
					 36-11-72(1).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:03 - Ownership or control by pharmacist required

Current through Register Vol. 51, page 10, July 15, 2024
The board may not issue a permit to conduct a remote pharmacy
				  to any pharmacist applicant unless such pharmacist applicant is an owner, or
				  part owner, of the place of business from which the pharmacist will practice
				  telepharmacy, or unless the non-pharmacist owner of the place of business from
				  which the pharmacist will practice telepharmacy files an affidavit on a form
				  prescribed by the board delegating full and complete authority to the
				  pharmacist applicant to be in active management of the place of business for
				  the license year ending June 30.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(1).
Law Implemented:
SDCL
					 36-11-34,
					 36-11-72.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:04 - Board inspection

Current through Register Vol. 51, page 10, July 15, 2024
No remote pharmacy may provide pharmacy services until the
				  board has inspected the remote pharmacy for minimum equipment, size, security,
				  and sanitation standards as set forth in §
									20:51:07:01 and found the remote
				  pharmacy to be in compliance with such standards.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(1).
Law Implemented:
SDCL
					 36-11-71,
					 36-11-72.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:05 - License renewal

Current through Register Vol. 51, page 10, July 15, 2024
A remote pharmacy license expires on June 30 of each year and
				  may be renewed annually by filing an application provided by the board. The
				  renewal fee is $200.
General Authority:
SDCL
					 36-11-72(1).
Law Implemented:
SDCL
					 36-11-72(1).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:06 - License required

Current through Register Vol. 51, page 10, July 15, 2024
Any pharmacy licensed by the board may operate a remote
				  pharmacy in South Dakota. The remote pharmacy is considered an extension of the
				  central pharmacy. However, the remote pharmacy must have its own license as a
				  pharmacy.
General Authority:
SDCL
					 36-11-72(1).
Law Implemented:
SDCL
					 36-11-72(1).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:07 - Audiovisual link

Current through Register Vol. 51, page 10, July 15, 2024
There must be a continuously accessible, two-way audiovisual
				  link between the central pharmacy and the remote pharmacy. The transmission of
				  information through the computer link must make information available to the
				  central pharmacy and the remote pharmacy simultaneously. The video camera used
				  for the certification of prescriptions must be of sufficient quality and
				  resolution so that the certifying pharmacist can visually identify the markings
				  on tablets and capsules. A second camera is required to meet security needs if
				  the camera used to certify prescriptions is not able to monitor activities in
				  other parts of the remote site.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(2).
Law Implemented:
SDCL
					 36-11-72(2).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:08 - Remote pharmacy identification sign

Current through Register Vol. 51, page 10, July 15, 2024
Each remote site shall display a sign easily viewable by
				  customers stating "This business is a remote pharmacy, supervised by a
				  pharmacist located at (
insert name of pharmacy and
				  address
)".
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(2),(5).
Law Implemented:
SDCL
					 36-11-72(2),(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:09 - Restricted area posted

Current through Register Vol. 51, page 10, July 15, 2024
The remote pharmacy dispensing area shall be posted as a
				  restricted area. Only pharmacy technicians or pharmacy interns employed
				  directly and involved in processing prescriptions are permitted in the
				  dispensing area. There must be restricted access to the restricted area. The
				  security system at the remote pharmacy must allow for tracking of each entry
				  into the pharmacy. The pharmacist-in-charge shall review the log of entries at
				  least weekly.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(2),(5).
Law Implemented:
SDCL
					 36-11-72(2),(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:10 - Telephone number

Current through Register Vol. 51, page 10, July 15, 2024
The remote pharmacy must provide a telephone number that
				  patients and prescribers may use to contact the central pharmacy. The telephone
				  number must be printed on the label of each prescription
				  container.
General Authority:
SDCL
					 36-11-11(1)(4),
					 36-11-46.6,
					 36-11-72(2)(5).
Law Implemented:
SDCL
					 36-11-71.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:11 - Pharmacist staffing requirements

Current through Register Vol. 51, page 10, July 15, 2024
Any pharmacist performing services in support of a remote
				  pharmacy, whether those services are performed at the central pharmacy or the
				  remote pharmacy, must be licensed by the board. A copy of the pharmacist's
				  license must be posted in any remote pharmacy to which the pharmacist provides
				  services.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-13,
					 36-11-72(3).
Law Implemented:
SDCL
					 36-11-72(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:12 - Technician and intern staffing requirements

Current through Register Vol. 51, page 10, July 15, 2024
Each remote pharmacy must be staffed with registered pharmacy
				  technicians or pharmacy interns. A pharmacy technician working at a remote
				  pharmacy without an onsite pharmacist, pharmacy intern, or experienced
				  telepharmacy technician, must have a minimum of two thousand hours of
				  experience as a registered pharmacy technician in accordance with chapter
				  20:51:29 and shall be certified in accordance with §
									20:51:29:06. One thousand hours of
				  this experience must be in a telepharmacy with an onsite pharmacist, intern, or
				  another pharmacy technician meeting the experience requirements for technicians
				  in this section. An intern may work at a remote pharmacy if the intern has five
				  hundred hours of experience as a registered pharmacy intern in accordance with
				  chapter 20:51:02.
General Authority:
SDCL
					 36-11-11(1)(13),
					 36-11-72(3).
Law Implemented:
SDCL
					 36-11-2(26),
					 36-11-25,
					 36-11-71.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:13 - Pharmacist-to-technician ratio

Current through Register Vol. 51, page 10, July 15, 2024
The pharmacist on duty at a central pharmacy may supervise no
				  more than the number of technicians allowed in accordance with §
									20:51:29:19. The total number of
				  allowed technicians may be divided between the central pharmacy and the remote
				  pharmacy in any manner. However, each remote pharmacy must have at least one
				  pharmacy technician or pharmacy intern on duty when it is
				  open.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(3).
Law Implemented:
SDCL
					 36-11-72(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:14 - Prescription workload

Current through Register Vol. 51, page 10, July 15, 2024
Any central pharmacy providing telepharmacy services shall
				  provide pharmacist staffing to meet the prescription workload of both the
				  central pharmacy and the remote pharmacy.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(3).
Law Implemented:
SDCL
					 36-11-72(3).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:15 - Requirements for prescription orders

Current through Register Vol. 51, page 10, July 15, 2024
Only a registered pharmacist may take a verbal prescription
				  order. A pharmacy technician at the remote pharmacy may not accept verbal
				  orders for new prescriptions, but may accept written orders. A written order
				  for a new prescription may be entered at the central pharmacy or the remote
				  pharmacy. The pharmacist must approve or override all drug utilization review
				  alerts.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(5).
Law Implemented:
SDCL
					 36-11-72(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:16 - Requirements for operation

Current through Register Vol. 51, page 10, July 15, 2024
The following requirements must be adhered to when operating
				  a remote pharmacy:
(1) The remote
				pharmacy may only be open if a computer link, video link, and audio link with
				the central pharmacy are functioning properly. If any link is not functioning
				properly, the remote pharmacy must be closed unless a pharmacist is working at
				the remote pharmacy;
(2) No remote
				pharmacy may be open when the central pharmacy is closed, unless a licensed
				pharmacist is working at the remote pharmacy;
(3) Any prescription filled at the remote
				pharmacy must be profiled, reviewed, and interpreted by a pharmacist at the
				central pharmacy before the prescription is dispensed;
(4) Any remotely dispensed prescriptions must
				have a label properly prepared in accordance with §
									20:51:05:21 attached to the final
				drug container before the pharmacist certifies the dispensing process. This
				prescription certification process must be done in real time. All prescription
				certification must be documented in the computer record. The computer must be
				capable of carrying the initials of the technician preparing the prescription
				and the pharmacist verifying the prescription. Verification is required for
				both new prescriptions and refills;
(5) When the patient receives a prescription,
				the pharmacist must use audiovisual communication to counsel the patient
				regarding use of the prescription being dispensed. Counseling is required only
				for new prescriptions. The pharmacist must meet the counseling standards in
				accordance with §
									20:51:25:04;
(6) The remote pharmacy must maintain a log,
				signed by the patient, that documents a patient's refusal for counseling by the
				pharmacist.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(2),(3),(4),(5).
Law Implemented:
SDCL
					 36-11-72(2),(3),(4),(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:17 - Routine quality assurance required

Current through Register Vol. 51, page 10, July 15, 2024
The pharmacist-in-charge must adhere to the following
				  procedures:
(1) An inspection of the
				remote pharmacy shall be conducted by a licensed pharmacist at weekly intervals
				or more if deemed necessary. Inspection must be documented and kept on file at
				the remote pharmacy and available upon request by the board;
(2) Implement and conduct a quality assurance
				plan that provides for on-going review of dispensing errors, with appropriate
				action taken, if necessary, to assure patient safety;
(3) Verify controlled substance prescriptions
				for both accuracy and legitimacy of the original prescription by the
				pharmacist-in-charge or a designated pharmacist during weekly inspection
				visits;
(4) Maintain records of all
				controlled substances stocked by the remote pharmacy through a daily perpetual
				inventory. Controlled substance perpetual inventory records must be available
				for inspection by the board's inspectors. A remote pharmacy stocking controlled
				drugs must be registered by the Drug Enforcement Administration and South
				Dakota Department of Health;
(5)
				Conduct an inventory of all controlled substances at least monthly to verify
				accuracy.
General Authority:
SDCL
					 36-11-11(1),
					 36-11-72(4),(5).
Law Implemented:
SDCL
					 36-11-72(4),(5).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:30 - Telepharmacy › Section 20:51:30:18 - Use of automated mechanical dispensing device

Current through Register Vol. 51, page 10, July 15, 2024
If the remote pharmacy uses an automated mechanical
				  dispensing device, the stocking and loading of this device must either be
				  checked by a pharmacist, prior to use, or employ a secure bar coding system or
				  its equivalent. Policies and procedures consistent with §
									20:51:17:02 regarding the
				  operation of the automated mechanical distribution system must be developed and
				  submitted to the board for consideration. After approval, these policies and
				  procedures must be available at both the central pharmacy and the remote
				  pharmacy.
General Authority:
SDCL
					 36-11-11(1),(6),
					 36-11-72(6).
Law Implemented:
SDCL
					 36-11-11(6),
					 36-11-72(6).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:01 - Definitions

Current through Register Vol. 51, page 10, July 15, 2024
Terms used in this chapter mean:
(1) "Compounding," the constitution,
				reconstitution, combination, dilution, or another process causing a change in
				the form, composition, or strength of any ingredient or any other attribute of
				a product;
(2) "Hazardous drug," a
				pharmaceutical that is antineoplastic, carcinogenic, mutagenic, or
				teratogenic;
(3) "Nonsterile
				compounding," the process of combining, admixing, diluting, pooling,
				reconstituting other than as provided in the manufacturer's labeling, or
				otherwise altering a drug or bulk drug substance to create a non-sterile
				preparation; and
(4) "Sterile
				compounding," the aseptic processing of any pharmaceutical preparation that is
				required to be sterile when administered to patients.
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 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:02 - Standards and procedures. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (4).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:03 - Manual required. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (4).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:04 - Physical environment requirements for sterile products. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (3), and
					 (4).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:05 - Requirement for primary engineering control device or room. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5).
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:06 - Placement of primary engineering control device. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5).
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:07 - Compounding aseptic isolator (CAI). Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5).
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:08 - Exception for placement of CAI. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5).
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:09 - Ante area requirements. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5).
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:10 - Delayed implementation. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (4), and
					 (5)
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:11 - Cleaning, maintenance, and supplies. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (3), and
					 (5)
Law Implemented:
SDCL
					 36-11-11,
					 36-11-41,
					 36-11-42.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:12 - Additional records required. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (4).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:13 - Quality assurance. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1),
					 36-11-68.
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:14 - Pharmacist responsibilities. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1),
					 36-11-41,
					 36-11-46.6.
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:15 - Training documentation. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:16 - Reference requirements. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (9).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:17 - Labeling requirements. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (12),
					 36-11-46.6.
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:18 - Microbial contamination risk levels. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1), (3), and
					 (5).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:19 - Low-risk preparations. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2(3),
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
Examples:
The single-volume transfer of
					 sterile dosage forms from ampoules, bottles, bags, and vials using sterile
					 syringes with sterile needles, other administration devices, and other sterile
					 containers. When ampoules are employed, solution content shall be passed
					 through a sterile filter to remove any particles. The manual measuring and
					 mixing of no more than three manufactured products including an infusion or
					 diluent solution to compound drug admixtures and nutritional
					 solutions.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:20 - Medium-risk preparations. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2(3),
					 36-11-11(1)
Law Implemented:
SDCL
					 36-11-11.
Examples:
Examples of medium-risk compounding
					 include:
(1) Compounding total parenteral nutrition fluids, using
					 manual or automated devices and involving multiple injections, detachments, or
					 attachments of nutrient source products to the device or machine to deliver all
					 nutritional components to a final sterile container;
(2) Filling reservoirs of injection or infusion devices
					 with more than three sterile drug products and evacuating air from those
					 reservoirs before dispensing the filled device; and
(3) Transferring volumes from multiple ampoules or vials
					 into one or more final sterile
					 containers.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:21 - High-risk preparations. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2(3),
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:22 - Immediate-use preparations. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2(3),
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:23 - Utilization of single-dose and multiple-dose containers. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:24 - Utilization of proprietary bag and vial systems. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:25 - Sterilization methods. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
The United States Pharmacopoeia, Thirtieth Revision -
					 The National Formulary, Twenty-Fifth Edition
, May 1, 2007, page 337,
					 published by the United States Pharmacopoeial Convention, Inc., 12601 Twinbrook
					 Parkway, Rockville, Maryland 20852. Cost:
					 $800.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:26 - Media-fill testing by personnel. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:27 - Environmental monitoring requirements. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
Note:
It is recommended that this be done
					 using a pressure gauge or a velocity meter installed between the buffer area
					 and ante area. In absence of a pressure gauge or velocity meter, unidirectional
					 flow and velocity should be tested and documented semi-annually at the time of
					 hood and room certification.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:28 - Storage and delivery of sterile preparations. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:29 - Additional requirements for preparation of hazardous drugs. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (5).
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:30 - Responsibilities for patient care. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (12),
					 36-11-68.
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:31 - Patient or caregiver education and training. Repealed

Current through Register Vol. 51, page 10, July 15, 2024
General Authority:
SDCL
					 36-11-2.2,
					 36-11-11(1) and
					 (12),
					 36-11-68.
Law Implemented:
SDCL
					 36-11-11.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:32 - Compounding and hazardous drug handling standards - United States Pharmacopeia compounding standards implemented by reference

Current through Register Vol. 51, page 10, July 15, 2024
All sterile compounding, nonsterile compounding, and
				  repackaging must be handled in accordance with federal law, this chapter, and
				  the United States Pharmacopeia-National Formulary (February 1, 2024), General
				  Chapter 797
Pharmaceutical Compounding - Sterile Preparations,
General Chapter 795
Pharmaceutical Compounding - Nonsterile
				  Preparations,
General Chapter 800
Hazardous Drugs - Handling
				  in Healthcare Settings,
and General Chapter 825
Radiopharmaceuticals - Preparation, Compounding, Dispensing, and
				  Repackaging
.
General Authority:
SDCL
					 36-11-11(3)(8).
Law Implemented:
SDCL
					 36-11-2.2(3),
					 36-11-11(3)(8),
					 36-11-46.
United States Pharmacopeia--Compounding
					 Compendium
(February 1, 2024), available at
https://online.uspnf.com/uspnf
.
					 Cost: $800 for individual user.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:33 - Policy and procedure manual

Current through Register Vol. 51, page 10, July 15, 2024
The pharmacist-in-charge must prepare and maintain a policy
				  and procedure manual for compounding practices. The policy and procedure manual
				  must include a quality assurance program, all applicable United States
				  Pharmacopeia requirements, and be available for inspection by the
				  board.
General Authority:
SDCL
					 36-11-11(3)(8).
Law Implemented:
SDCL
					 36-11-2.2(3),
					 36-11-46.
United States Pharmacopeia--Compounding
					 Compendium
(February 1, 2024), available at
https://online.uspnf.com/uspnf
.
					 Cost: $800 for individual user.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:34 - Compounding requirements

Current through Register Vol. 51, page 10, July 15, 2024
Any pharmacy that engages in compounding must adhere to
				  physical, equipment, and environmental requirements established by United
				  States Pharmacopeia. Pharmacy compounding staff shall have access to current
				  reference materials applicable to compounding.
General Authority:
SDCL
					 36-11-11(3)(8).
Law Implemented:
SDCL
					 36-11-2.2(3),
					 36-11-46.
United States Pharmacopeia--Compounding
					 Compendium
(February 1, 2024), available at
https://online.uspnf.com/uspnf
.
					 Cost: $800 for individual user.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:35 - Delivery to patients

Current through Register Vol. 51, page 10, July 15, 2024
The pharmacist-in-charge shall ensure the environmental
				  control, stability, and sterility of all preparations delivered or shipped to
				  patients.
General Authority:
SDCL
					 36-11-11(3)(4).
Law Implemented:
SDCL
					 36-11-44.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:36 - Disposal of pharmaceutical hazardous waste

Current through Register Vol. 51, page 10, July 15, 2024
The pharmacist-in-charge is responsible for ensuring that
				  there is a designated process for proper disposal of pharmaceutical hazardous
				  waste in accordance with applicable state and federal
				  requirements.
General Authority:
SDCL
					 36-11-11(3).
Law Implemented:
SDCL
					 36-11-2.2(3),
					 36-11-46.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:37 - Quality assurance

Current through Register Vol. 51, page 10, July 15, 2024
Any pharmacy that compounds prescriptions must have a quality
				  assurance program with the following elements:
(1) A documented, ongoing program for the
				monitoring of personnel, components, equipment, and facilities used for
				preparation of compounded pharmaceuticals that conforms to applicable state and
				federal law;
(2) If errors have
				occurred, the pharmacist-in-charge is responsible for conducting a full
				investigation. A written record of the investigation must be completed and
				include conclusions and follow-up;
(3) The pharmacist-in-charge is responsible
				for proper maintenance, cleanliness, and use of facilities and equipment used
				in compounding;
(4) All pharmacists
				and pharmacy technicians, who assist in compounding drug products, must have
				documented training and competency testing as required by state and federal
				law;
(5) Training must be conducted
				by qualified individuals on a continuing basis with frequencies outlined in
				United States Pharmacopeia to ensure that compounding pharmacy personnel remain
				up to date with operations, policies, and procedures;
(6) Only personnel authorized by the
				pharmacist-in-charge may be in the immediate vicinity of compounding
				operations; and
(7) A compounded
				drug is adulterated if it has been prepared, packed, or held under insanitary
				conditions. For the purpose of this section, "insanitary conditions" means a
				condition of exposure to contamination with filth which may be rendered
				injurious to health.
General Authority:
SDCL
					 36-11-11(3).
Law Implemented:
SDCL
					 36-11-2.2(3),
					 36-11-42,
					 36-11-46.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:31 - COMPOUNDING PRACTICES › Section 20:51:31:38

Current through Register Vol. 51, page 10, July 15, 2024
The adopted version of this section by
				  50
				  SDR 139, effective
				  6/2/2024 is not yet
				  available.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:01 - Definitions

Current through Register Vol. 51, page 10, July 15, 2024
Terms defined in SDCL
				  34-20E-1 have the same meaning in
				  this article.
General Authority:
SDCL
					 34-20E-20.
Law Implemented:
SDCL
					 34-20E-1,
					 34-20E-20.
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:02 - Data submission

Current through Register Vol. 51, page 10, July 15, 2024
Each dispenser may submit the data to the central repository
				  using any electronic device compatible with the board's receiving device or the
				  receiving device of the board's contracted vendor every 24 hours or by midnight
				  of the next business day after dispensing. The data submitted to the central
				  repository may be on electronic media approved by the board accompanied by a
				  transmittal form identifying the dispenser submitting the electronic media, the
				  number of prescription records included on the media, and the individual
				  submitting the media.
If the dispenser does not have an automated recordkeeping
				  system capable of producing an electronic report of the required data in the
				  format established by the American Society for Automation in Pharmacy (ASAP),
				  the dispenser may request a waiver from the electronic reporting requirement
				  from the board.
If the board grants a waiver from the electronic reporting
				  requirement, then the dispenser shall comply with an alternative method of
				  reporting the data as determined by the board, such as submitting the required
				  data on a form approved by the board.
General Authority:
SDCL
					 34-20E-20.
Law Implemented:
SDCL
					 34-20E-2,
					 34-20E-3,
					 34-20E-20(1).
South Dakota Administrative Rules › Title 20 - PUBLIC SAFETY › Article 20:51 - PHARMACISTS › Chapter 20:51:32 - Prescription drug monitoring program › Section 20:51:32:03 - Data elements

Current through Register Vol. 51, page 10, July 15, 2024
The information submitted for each prescription shall
				  include the following items:
(1)
				Dispenser name and identification number;
(2) Date prescription filled;
(3) Prescription number;
(4) Prescription is new or is a
				refill;
(5) Identification code for
				drug dispensed;
(6) Quantity
				dispensed;
(7) Day's supply
				dispensed;
(8) Number of refills
				ordered;
(9) Patient
				name;
(10) Patient
				address;
(11) Patient date of
				birth;
(12) Patient
				gender;
(13) Prescriber
				identification number;
(14) Date
				prescription issued by the prescriber;
(15) Pharmacy phone number;
(16) Code identifying type of
				payment;
(17) Prescriber last
				name;
(18) Prescriber first name;
				and
(19) Prescriber phone
				number.
General Authority:
SDCL
					 34-20E-20(2).
Law Implemented:
SDCL
					 34-20E-2,
					 34-20E-3,
					 34-20E-20(2).