JOB TITLE: DRUG PROGRAM SPECIALIST

JOB CODE: 38310

DEFINITION: This is professional and specialized inspection and investigation work related to enforcing regulations governing the practice of pharmacy.

An employee in this job performs inspections and investigations on new and existing pharmacies to enforce compliance with federal and state laws and regulations governing drugs, medical devices, cosmetics, and pharmacy practices. Work involves evaluating pharmacy operations for adherence to standards related to sanitation, adulteration, misbranding, and overall product integrity. Work includes inspecting and investigating quality control systems within distribution channels and enforcing applicable laws and regulations to ensure public health and safety. Work is performed independently and is reviewed through conferences and reports.

EXAMPLES OF WORK: (NOTE: The examples of work are representative of the work, but every position classified to this job may not perform all examples of work listed. Conversely, this is not an all-inclusive list of work examples.)

• Inspects and investigates pharmacies and pharmaceutical practices in a designated territory for violations of federal and state laws, focusing on quality control and compliance with regulations related to adulterating, labeling, sanitation, misleading advertising, and distribution of drugs, medical devices, and cosmetics.

• Reviews pharmacy records, files, policies, and procedures for compliance with federal and state laws, rules and regulations.

• Collects evidence and information during inspections to prepare reports, issue citations, revoke or deny the issuance of a license for the pharmacy or pharmacist or initiate other corrective or enforcement action.

• Utilizes an online licensing system to issue citations, schedule and perform inspections and reinspections, and review past inspection history, complaints, and pending disciplinary and legal actions.

• Conducts post-inspection reviews with the pharmacist on duty to review the inspection findings and discuss any concerns, violations, or requests for formal action, and issues a warning or citation for violations that may result in a fine.

• Analyzes information, prepares findings of inspections for legal cases, and appears as a prosecuting witness in court cases where there is a suspected violation of law.

• Operates motor vehicles.

• Performs related work as required.

ENTRY LEVEL KNOWLEDGES, SKILLS, AND ABILITIES:

• Knowledge of component parts of drugs, devices, and cosmetics.

• Knowledge of the principles and technical terminology of pharmacology.

• Knowledge of compounding practices, sterile compounding, hazardous drug handling, and other guidelines as they relate to the United States Pharmacopeia (USP) Pharmacy Standards.

• Knowledge of laws and regulations governing the manufacturing, distribution, and sale of drugs, devices, and cosmetics.

• Knowledge of the use and functionality of Microsoft Office Suite software.

• Ability to determine the legality of the sale and distribution of drugs, devices, and cosmetics.

• Ability to operate motor vehicles.

• Ability to communicate effectively orally.

• Ability to communicate effectively in writing.

• Ability to establish and maintain effective working relationships.

SPECIAL REQUIREMENTS:

• All positions require possession of an active license to practice pharmacy as issued by the Pennsylvania State Board of Pharmacy.

• All positions require possession of an active motor vehicle license.