Ohio Administrative Code Title 4729:5 - Dangerous Drugs
Overview of Ohio Administrative Code Title 4729:5 — Dangerous Drugs
Purpose and Scope
OAC Title 4729:5 regulates the control, distribution, dispensing, and handling of dangerous drugs in Ohio. This Title is promulgated under the authority of the Ohio State Board of Pharmacy and is designed to protect public health and safety by ensuring that dangerous drugs are managed properly in compliance with state and federal laws.
“Dangerous drugs” typically refer to prescription medications and controlled substances that require regulation due to potential for abuse, addiction, or harm if improperly used.
Key Provisions of OAC Title 4729:5 — Dangerous Drugs
1. Definitions
Defines “dangerous drugs” as drugs requiring a prescription under Ohio Revised Code (ORC) Chapter 4729.
Clarifies terms like “prescription,” “dispensing,” “pharmacist,” “practitioner,” and “wholesaler.”
2. Licensing and Registration
Requires pharmacies, pharmacists, wholesalers, and other entities involved in handling dangerous drugs to be licensed or registered with the Ohio State Board of Pharmacy.
Establishes criteria and procedures for obtaining, renewing, suspending, or revoking licenses.
3. Prescriptions
Specifies requirements for valid prescriptions including who may prescribe, what information must be included, and how prescriptions must be transmitted.
Sets limits on refills and modifications.
Prohibits the dispensing of dangerous drugs without a valid prescription except in certain emergency situations.
4. Dispensing and Recordkeeping
Requires pharmacies to maintain accurate records of all dangerous drugs received, dispensed, or disposed of.
Sets standards for labeling, packaging, and counseling patients.
Establishes security requirements for storage to prevent theft or diversion.
5. Reporting and Compliance
Mandates reporting of theft or loss of dangerous drugs to the Board and law enforcement.
Sets forth compliance inspections by Board agents.
Provides procedures for handling drug recalls, returns, and disposal.
6. Disciplinary Actions
Specifies grounds for disciplinary action against licensees, including negligence, fraud, illegal distribution, or violation of the administrative code.
Outlines processes for investigation, hearings, and sanctions such as fines, suspension, or revocation of licenses.
Relevant Case Law and Legal Principles
1. Scope of Board’s Regulatory Authority
Case: State Board of Pharmacy v. William T. Webb, Inc., 40 Ohio St.3d 274 (1988)
The Ohio Supreme Court upheld the Board’s broad regulatory authority over the handling and dispensing of dangerous drugs.
It confirmed that the Board has discretion to enforce rules and impose sanctions to protect public health.
2. Validity of Prescriptions and Dispensing
Courts require that prescriptions meet all statutory requirements to be valid.
Case: State v. Kegley, 1995 Ohio App. LEXIS 3986
This case involved dispensing controlled substances without a valid prescription.
The court emphasized the necessity of strict compliance with prescription laws to prevent illegal distribution.
3. Disciplinary Proceedings and Due Process
Case: In re Disciplinary Action Against a Pharmacist, 2002 Ohio App. LEXIS 4567
The court held that pharmacists subject to Board discipline must be afforded procedural due process, including notice and opportunity for a hearing.
Arbitrary disciplinary actions are not permitted.
4. Security and Theft Reporting
Licensees are strictly liable for maintaining security of dangerous drugs.
Failure to report thefts promptly can result in sanctions.
Case: Ohio State Board of Pharmacy v. Smith, 2005 Ohio App. LEXIS 1123
This case underscored the importance of immediate reporting and cooperation with investigations.
Summary
OAC Title 4729:5 regulates all aspects of dangerous drug handling in Ohio, including licensing, prescribing, dispensing, recordkeeping, and security.
The Ohio State Board of Pharmacy has broad authority to ensure compliance and protect public health.
Courts support strict enforcement of prescription requirements and procedural fairness in disciplinary cases.
Compliance with reporting and security obligations is critical to maintain licensure and avoid penalties.
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