Pharmacy Law and Regulatory Compliance
Sources and hierarchy
Federal statutes and regulations (FDCA, CSA, HIPAA) set a floor; states may impose stricter requirements. Kentucky's core is KRS Chapter 315 and Title 201 KAR Chapter 2, with controlled substances in KRS Chapter 218A. When two rules apply, follow the stricter one - that is the single most useful conflict rule on this exam.
How enforcement works
A complaint triggers Board inquiry, then investigation, then an administrative complaint and hearing before a hearing officer or administrative law judge, then a Board order, with appeal to circuit court. Sanctions include reprimand, fine, restrictions, probation, suspension, and revocation. Due process rights apply throughout.
Compliance points that generate questions
Board subpoena power over patient records; confidentiality of investigative files; the duty to cooperate with inspectors; advertising and internet pharmacy rules; and the fact that HIPAA does not shield records from a lawful Board subpoena, though disclosure should be limited to what is required. “No patient was harmed” is not a defense to a practice violation - the violation stands on its own.
Traps: assuming a federal registration immunizes state discipline; assuming conduct outside the pharmacy (fraud, impairment, diversion) is beyond the Board's reach; assuming a closed investigation means a clean record.
Rule of thumb: when patient safety and convenience conflict, choose safety; when state and federal rules conflict, choose the stricter.