According to the California State Board of Pharmacy (“Board”), to be licensed as a Designated Representative in California, you must satisfy the requirements under Business and Professions Code section 4053. Wholesale operations that distribute dangerous drugs or dangerous devices must be supervised by a registered pharmacist or an individual approved by the Board as a Designated Representative. These companies may not operate unless the pharmacist or Designated Representative is physically on the licensed premises. To ensure proper control at all times, the Board recommends that there be more than one person approved to supervise operations.
There are quite a number of requirements that have to be met in order to qualify as a Designated Representative, including the following training requirements listed on the Designated Representative (wholesaler) application form:
Complete a training program required by Section 4053(3) of the California Business and Professions Code that addresses, at a minimum:
A. Knowledge and understanding of California and federal laws regarding the distribution of dangerous drugs and dangerous devices;
B. Knowledge and understanding of California and federal laws regarding the distribution of controlled substances;
C. Knowledge and understanding of United States Pharmacopoeia standards for the safe storage and handling of drugs;
D. Knowledge and understanding of quality control systems; and
E. Knowledge and understanding of prescription terminology, abbreviations, dosages and format.
The trick then becomes finding a way to fulfill the training program requirement. I’ve posted a link to a popular training service provider below.
California Designated Representative Training Courses by SkillsPlus International Inc. — Approved by the California State Board of Pharmacy — Earns a filled-out training affidavit form accepted by the Board.