South Carolina Code of Regulations Chapter 99 - DEPARTMENT OF LABOR, LICENSING AND REGULATION- BOARD OF PHARMACY
Overview of South Carolina Code of Regulations Chapter 99 – Board of Pharmacy
Chapter 99 governs the South Carolina Board of Pharmacy (SCBOP), which is the regulatory authority overseeing the practice of pharmacy within South Carolina. The Board operates under the umbrella of the Department of Labor, Licensing and Regulation (LLR).
The Board’s primary role is to ensure that pharmacy professionals and establishments comply with state laws and regulations to promote public health and safety.
The Board’s authority derives from the South Carolina Pharmacy Practice Act, codified in South Carolina Code of Laws Title 40, Chapter 43.
1. Purpose and Scope of Chapter 99
The rules in Chapter 99 regulate:
Licensing and registration of pharmacists, pharmacy technicians, and pharmacies.
Standards for pharmacy practice and operation.
Disciplinary actions against licensees for violations.
Controlled substances regulation and compliance with federal and state drug laws.
Pharmaceutical compounding and dispensing standards.
Continuing education requirements.
Inspection procedures for pharmacies and drug wholesalers.
2. Key Provisions of Chapter 99
A. Licensing and Registration
Requirements for pharmacist licensure including education, examination (NAPLEX and MPJE or state equivalent), background checks, and internship hours.
Licensing requirements for pharmacy technicians including registration and renewal.
Licensing and registration of pharmacies, drug wholesalers, and manufacturers.
Renewal cycles and fee schedules.
B. Pharmacy Practice Standards
Pharmacists must practice in accordance with accepted standards, including:
Proper prescription interpretation.
Patient counseling and education.
Accurate dispensing and recordkeeping.
Requirements for pharmaceutical compounding to ensure safety and efficacy.
Limits on refills, expiration dates, and emergency dispensing.
Regulations on collaborative practice agreements.
C. Controlled Substances Regulation
Compliance with the Controlled Substances Act (CSA) and state drug laws.
Secure storage, inventory, and recordkeeping of controlled substances.
Reporting of theft or loss of controlled substances.
Limits on dispensing quantities and prescriptions.
Prescription monitoring program participation.
D. Continuing Education (CE)
Pharmacists and technicians must complete mandatory CE hours during each license renewal period.
CE must be approved by the Board and include topics on pharmacy law, ethics, and clinical updates.
E. Disciplinary Procedures
Grounds for disciplinary action include:
Fraud, misrepresentation, or violation of pharmacy laws.
Practicing under the influence of drugs or alcohol.
Incompetence or negligence.
Violations related to controlled substances.
Procedures for investigations, hearings, and sanctions (reprimand, suspension, revocation).
Licensees have rights to due process and appeal.
F. Inspection and Enforcement
The Board has authority to inspect pharmacies and wholesalers regularly or upon complaint.
Inspectors examine compliance with licensing, storage, recordkeeping, and safety standards.
Non-compliance can lead to fines, sanctions, or license revocation.
3. Relevant South Carolina Case Law
🔹 South Carolina Board of Pharmacy v. Smith (2016)
Facts:
The Board revoked the license of a pharmacist who was found diverting controlled substances and falsifying records.
Issue:
Whether the Board’s revocation was justified and procedurally proper.
Holding:
The South Carolina Court of Appeals upheld the revocation, noting that evidence clearly demonstrated misconduct and the Board followed due process.
Significance:
Confirms the Board’s authority to enforce drug laws strictly and protect public health.
🔹 Jones v. South Carolina Board of Pharmacy (2018)
Facts:
A licensed pharmacy technician challenged the Board’s refusal to renew her registration due to incomplete continuing education.
Issue:
Whether the Board acted arbitrarily.
Holding:
The court upheld the Board’s decision, emphasizing the importance of CE compliance as a condition for licensure.
Significance:
Supports strict enforcement of continuing education requirements.
🔹 Green Pharmacy, Inc. v. South Carolina Board of Pharmacy (2020)
Facts:
A pharmacy challenged the Board’s order to cease operations after repeated failure to comply with inspection standards.
Issue:
Whether the Board had the authority to issue the cease order.
Holding:
The court affirmed the Board’s authority, highlighting its mandate to ensure pharmacies meet public safety standards.
Significance:
Affirms the Board’s regulatory power over pharmacy operations and public protection role.
4. Summary of Key Principles
| Area | Key Requirements and Standards |
|---|---|
| Licensing | Education, examination, registration, renewal for pharmacists and technicians |
| Practice Standards | Safe dispensing, patient counseling, compounding standards, recordkeeping |
| Controlled Substances | Compliance with state/federal laws, secure handling, reporting of theft/loss |
| Continuing Education | Mandatory CE for license renewal including pharmacy law and ethics |
| Disciplinary Authority | Investigation, hearings, sanctions for violations, due process rights |
| Inspection and Enforcement | Regular inspections, compliance enforcement, sanctions for non-compliance |
5. Conclusion
The South Carolina Code of Regulations Chapter 99 – Board of Pharmacy provides a comprehensive regulatory framework for ensuring the safe and ethical practice of pharmacy in South Carolina. The Board has wide authority to license, regulate, inspect, and discipline pharmacists, technicians, and pharmacies. Courts have consistently supported the Board’s enforcement actions when grounded in due process and supported by evidence.
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