11/01/1967 38310

DRUG PROGRAM SPECIALIST 1

DEFINITION: This is introductory professional inspection and investigative work in the regulation of drug, advice, and cosmetic manufacturing and wholesaling.

An employee in this class performs inspections and investigations of drug, device, and cosmetic manufacturing plants and wholesalers to enforce compliance with Federal and state laws. Work involves investigating the manufacturing processes and the sales of drugs, devices, and cosmetics in the areas of sanitation, adulteration, misbranding, misleading advertising, manufacturing processes, quality control systems, and distribution. Employees work under the supervision of higher-level specialists who give training in specific regulations and in investigative procedures, and who review work for conformance with established methods and for reliability of conclusions.

EXAMPLES OF WORK: Inspects and investigates drug, device, and cosmetic manufacturing plants and wholesalers to determine and enforce compliance with legislation regarding sanitation, adulteration, misbranding, misleading advertising, manufacturing processes, quality control systems, and proper distribution of drugs at the manufacturers' and wholesalers' level.

Inspects and investigates the possible adulteration of component parts of manufactured products and the labeling and advertising of such products to protect the buyer against illegal manufacturing and to insure the buyer that the product is manufactured in accordance with Federal and state standards.

Investigates sales, at the manufacturers' level, of drugs, devices, and cosmetics to determine legality of sale and to obtain information for legal action against manufacturers where laws have been broken.

Gathers information and evidence in cases where a violation of the law is suspected and appears and offers testimony in court as a prosecuting witness.

Prepares detailed reports of inspections and investigations.

Performs related work as required.

REQUIRED KNOWLEDGES, SKILLS, AND ABILITIES: Considerable knowledge of component parts of drugs, devices, and cosmetics.

Knowledge of technical terminology of drugs, devices, and cosmetics.

Knowledge of the current developments in the field of pharmacology and in legislation regulating drugs, devices, and cosmetics.

Some knowledge of the principles and methods of inspection and investigation.

Some knowledge of the Federal and state laws regulating the manufacture, distribution, and sale of drugs, devices, and cosmetics.

Some knowledge of the basic rules of evidence and court proceedings.

Ability to determine, by inspection and investigation, the use of proper manufacturing methods for drugs, devices, and cosmetics with emphasis on sanitation, labeling, and advertising.

Ability to determine, through record audit, the legality of sale and distribution of drugs, devices, and cosmetics.

Ability to gather and present evidence in an orderly fashion and to express these facts clearly and concisely, orally and in writing.

Ability to understand, interpret, and enforce legislation regarding the manufacture, distribution, and sale of drugs, devices, and cosmetics.

Ability to establish and maintain effective working relationships with the public and representative of the drug industry.

NECESSARY SPECIAL REQUIREMENT: Possession of a license to practice pharmacy as issued by the Pennsylvania State Board of Pharmacy.