Do California Drug Manufacturers need to be licensed as wholesalers?

In some cases yes. CA law in BP 4160(f) states: A drug manufacturer premises licensed by the FDA or CA FDB that only distributes dangerous drugs and dangerous devices of its own manufacture is exempt from this section (wholesaler licensing) and from Section 4161 (Non-Resident Wholesaler Licensing).

Interpretation: If you are a drug manufacturer and you are shipping drugs that you manufacture from the same address which they are manufactured at, then you do not need to be licensed as a drug wholesaler or a non-resident drug wholesaler in California.

If, on the other hand, you are storing products in a separate distribution center or with a 3rd party logistics company (3PL) and negotiating their shipping from those facilities, then you are required to be licensed as a drug wholesaler or non-resident drug wholesaler in CA. Most of the "virtual" manufacturers fall into this category.

The separate DC or 3PL also needs to be licensed as a wholesaler and each facility must have a CA licensed Designated Representative on the premises. The DR is responsible for the facility's compliance with all applicable laws.

Welcome To Our Blog!

Welcome to our Designated Representative blog for drug wholesalers and manufacturers! Providing a place for our seminar attendees to come to get updated information has been a long time coming. We'll be providing periodic updates and happenings in the drug distribution and manufacturing industry. We will highlight new laws, enforcement issues as well as provide some general info and about what is happening in the ever-changing and challenging environment of drug distribution.