PharmacyWholesalers, Third-party Logistics Providers, and Manufacturers
Section § 4160
If you want to be a wholesaler or third-party logistics provider for dangerous drugs or devices, you need a special license from the board. Each business location must have its own license, which has to be renewed every year and can't be transferred. There must be a designated representative at each location to ensure compliance with the law. If you run both a wholesaler and a logistics business under the same roof, you must keep things separate, like records and stock, and have different people in charge of each operation. If your manager quits, you need to tell the board and propose a new manager quickly. Some manufacturers are exempt from these rules. Also, the board can give temporary licenses under certain conditions, but it's not a guaranteed right to keep them.
Section § 4160.5
This law requires manufacturers of nonprescription diabetes test devices to list their authorized distributors on their own websites and inform the board within 30 days of any updates. The board must then post these distributor lists on its website within 30 days of receiving such information. This process ensures transparency and up-to-date information about who is authorized to distribute these medical devices.
Section § 4161
This law outlines the requirements for companies located outside California that deal with dangerous drugs or devices in the state. Such companies, known as nonresident wholesalers or third-party logistics providers, must have a state license before they can conduct business involving these items. Each business location needs its own license, although companies under common ownership can share a location under certain conditions, like keeping separate records and managers. Companies must report key details to the board, such as ownership and management changes, and must maintain compliance with both state and federal laws. Temporary licenses may be issued in certain circumstances, but they don’t guarantee a permanent license. This law will take effect on January 1, 2025.
Section § 4161.5
This law states that when the federal government sets new rules for a specific section of the Federal Food, Drug, and Cosmetic Act, the California board must promptly identify and resolve any conflicts between these federal rules and California's own laws related to interstate commerce.
Section § 4162
If you’re applying for or renewing a wholesaler or third-party logistics provider license in California and it’s not owned by the government, you need to submit a bond—$100,000 for wholesalers and $90,000 for logistics providers. This bond helps ensure any fines or penalties are paid if needed. However, if your business made $10 million or less last year, the bond can be reduced to $25,000. If you're a drug manufacturer with FDA approval who only distributes the drug specified in your application, you don’t need to post this bond. But, if you’ve been penalized or fined in the past, the board might still ask for a bond up to $100,000. The board can use the bond to cover unpaid fines 30 days after they become final. A single bond can cover all locations under the same control.
Section § 4162.5
If you're applying for or renewing a nonresident wholesaler or third-party logistics license, you need a $100,000 or $90,000 bond, respectively, to ensure you can pay any fines. If your business made $10 million or less last year, the bond can be reduced to $25,000. However, if you have a record of being fined, the board may still require up to $100,000. If your wholesale distribution is only for a specific drug approved by the FDA, you don't need a bond at all. If you don't pay fines on time, the board can claim your bond money. One bond can cover multiple locations if they're under one business control.
Section § 4163
This law section explains that manufacturers, wholesalers, repackagers, or pharmacies can't give dangerous drugs or devices to people who aren't authorized to have them. Generally, these drugs or devices should only be obtained from people legally authorized to have or provide them. For wholesalers, their main duty is to verify the license of new sources. However, if a reverse distributor, which is a wholesaler who deals with returns and destruction, gets approval from the board, they can acquire dangerous drugs or devices from an unlicensed source if it was previously licensed, but only to destroy it.
Section § 4164
This law requires wholesalers and third-party logistics providers in California who distribute controlled substances and dangerous drugs to report any distributions of these substances, especially if they're prone to abuse. They must also keep a system to track sales of dangerous drugs sold at discounted prices to pharmacies that serve long-term care facilities. This system should be able to spot unusual purchasing patterns. Wholesalers have to provide sales data upon request and have 30 days to do so. 'Preferential or contract prices' are defined as drug sales below normal wholesale prices.
Section § 4165
If you are a wholesaler or logistics provider dealing with potentially harmful drugs or devices and you either bring these items into California or receive them from someone in the state, you need to keep thorough records of the transaction. If a police officer asks, you must show them these records.
Section § 4166
This law makes wholesalers responsible for keeping dangerous drugs or devices secure until they're delivered to the proper recipient, even if a third-party logistics provider or carrier like the Postal Service is involved. Third-party logistics providers must have written policies to ensure carriers also maintain this security and confirm that recipients are authorized to receive these items. This liability only applies until the drugs or devices reach the recipient's premises.
Section § 4167
This law states that wholesalers and third-party logistics providers must be able to securely store any dangerous drugs or devices they acquire at their licensed business location.
Section § 4168
This law states that counties or cities in California cannot give a business license to places that need a wholesaler or third-party logistics provider license unless they already have one from the board. "Establishment" here means the physical location of the business in California.
Section § 4169
This law section prohibits certain activities involving dangerous drugs or devices. A person or entity cannot buy, sell, or transfer these items wholesale unless they are licensed. It also bans dealing with drugs that are known or should be known as adulterated, misbranded, or expired. Records of transactions must be kept for three years. Violations are subject to fines, and any collected fines are used to support the Pharmacy Board. However, pharmaceutical manufacturers licensed by FDA or the State Department of Public Health are exempt.
Section § 4169.1
If a wholesaler notices any suspicious orders for drugs from a California pharmacy or another wholesaler, they must report it in writing to the board. This includes sending the same information they give to the DEA. Suspicious orders could be really big, far outside the normal order pattern, or unusually frequent.