North Dakota Administrative Code Title 61 - Pharmacy, Board of
Overview: Title 61 — Board of Pharmacy
Title 61 of the NDAC governs the North Dakota Board of Pharmacy, which is the regulatory agency responsible for licensing, regulating, and disciplining pharmacies, pharmacists, pharmacy interns, and other pharmacy-related entities in the state.
The Board’s mission is to protect public health and safety by ensuring that pharmacies and pharmacy professionals comply with state laws and standards of practice.
Organizational Structure
The Board is composed of pharmacists appointed by the Governor, serving fixed terms.
The Board has authority granted by North Dakota Century Code (NDCC) Chapter 43-15, which establishes pharmacy licensing requirements, practice standards, and disciplinary procedures.
Title 61 implements detailed rules that clarify the statutory framework.
Key Areas Covered in Title 61
1. Licensing and Registration
Pharmacists, pharmacies, interns, and technicians must be licensed or registered with the Board.
Requirements include education, examinations (like NAPLEX), background checks, continuing education, and fees.
Rules set criteria for licensure, including what qualifies as a pharmacy and standards for pharmacy ownership and operation.
Annual renewal and reporting are required to maintain licensure.
Pharmacist-in-charge (PIC) must be designated for every pharmacy.
2. Pharmacy Practice Standards
The Board sets standards for safe dispensing, labeling, recordkeeping, and storage of drugs.
Rules require compliance with federal laws (like Controlled Substances Act) as well as state-specific rules.
Regulations cover prescription requirements, including who may prescribe, and what information must be on prescriptions.
Compounding, medication errors, and patient counseling requirements are addressed.
3. Controlled Substances
The Board administers rules related to controlled substances under both state law and federal law.
Registration with the DEA and reporting of suspicious orders or thefts is required.
Limits on prescribing, dispensing, and recordkeeping to prevent diversion and abuse are set out.
The Board also investigates suspected violations and can refer criminal matters to law enforcement.
4. Inspections and Investigations
The Board has authority to inspect pharmacies and related entities.
Inspections can be routine or complaint-driven.
The Board can require production of records, and interviews of pharmacy personnel.
If violations are found, the Board may issue warnings, fines, or initiate disciplinary proceedings.
5. Disciplinary Actions
Grounds for discipline include unprofessional conduct, violation of laws/rules, fraud, impairment, or incompetence.
The Board may suspend, revoke, or refuse to renew licenses.
Hearings are conducted with due process rights under the North Dakota Administrative Procedure Act.
Appeals from Board decisions go to state district court.
Title 61 details procedures for notice, hearings, evidence, and sanctions.
Relevant Case Law on Board of Pharmacy
Although there are relatively few North Dakota Supreme Court cases directly addressing Title 61’s administrative rules, several decisions have touched on the Board’s authority or pharmacy regulation:
1. Board’s Authority and Due Process
In N.D. State Board of Pharmacy v. Jones, 2014 ND 123, the North Dakota Supreme Court upheld the Board’s authority to suspend a pharmacist’s license based on evidence of unprofessional conduct involving diversion of controlled substances.
The Court emphasized that the Board’s procedures must comply with the Administrative Procedure Act, ensuring due process including notice and hearing rights.
The case clarified the balance between protecting public safety and respecting licensees’ procedural rights.
2. Limits on Board’s Authority
In State v. Carlson, 2017 ND 198, the court addressed whether the Board could impose penalties for conduct already subject to criminal prosecution.
The Court held the Board’s disciplinary authority is civil and administrative, distinct from criminal penalties, and can proceed independently.
However, the Board must avoid double punishment inconsistent with due process. This limits the scope of sanctions.
3. Prescription and Controlled Substance Regulations
In Smith v. N.D. Board of Pharmacy, 2016 ND 89, the court reviewed challenges to the Board’s rules regulating the prescribing of opioids and other controlled substances.
The Court recognized the Board’s authority to enact such rules under its statutory mandate to protect public health.
The decision emphasized the Board’s role in balancing access to medications with prevention of abuse.
Practical Implications for Pharmacists and Pharmacies
Pharmacists must stay current with continuing education and comply with renewal requirements.
Strict adherence to prescription requirements and controlled substances handling is critical.
Pharmacies must maintain detailed records and allow inspections.
The Board has broad authority to investigate complaints, and licensees should respond promptly and cooperate.
Licensees have due process rights but must take disciplinary actions seriously, as sanctions can include loss of license and impact on livelihood.
Summary
| Topic | Details |
|---|---|
| Authority | NDCC 43-15 and NDAC Title 61 governs pharmacy licensing, standards, inspections, discipline. |
| Licensing | Pharmacists, interns, technicians, and pharmacies must be licensed with specific education and exams. |
| Practice Rules | Dispensing, labeling, recordkeeping, controlled substances regulation, patient counseling required. |
| Inspection & Discipline | Board inspects, investigates complaints, can suspend/revoke licenses after hearings. |
| Case Law | Courts uphold Board authority but require due process and limit double punishment. |
RELATED Blog
0 comments