Pharmaceutical Third Party Logistics Provider Licensing

Learn about licensing requirements for pharmaceutical third party logistics providers.

Overview of Third Party Logistics Provider Licensing Requirements

Given the amount of regulation in the pharmaceutical sector, it should come as no surprise that entities providing logistical services for pharmaceutical products are often subject to their own licensing requirements. In many states, third party logistics providers (3PLs) must obtain a license before providing or coordinating warehousing, transportation, or other logistics services for pharmaceutical wholesalers or distributors.

3PL licenses are typically issued by the state board of pharmacy, although some states give this authority to the department of health or department of agriculture. In a few states, 3PLs are required to obtain a wholesaler or distributor license even though 3PLs generally do not take ownership of the products they coordinate logistics for.

License requirements vary by state, but most applications ask for:

• Business entity information
• A list of officers and owners of the business
• The types of services provided
• Information about the individual/manager in charge of the facility
• A copy of the home state license for foreign entities
• A copy of a Verified-Accredited Wholesale Distributors (VAWD) accreditation
• Application and license fees

Depending on the services they offer and the products they deal with, 3PLs may also be required to apply for controlled substance registrations. At the state level, controlled substance registrations are usually issued through the same agency that administers pharmacy licenses, but 3PLs may also need to obtain a federal controlled substances act registration through the Drug Enforcement Administration (DEA).

Licenses are issued on a per-location basis, so 3PLs that operate multiple facilities will need to obtain separate licenses for each facility they own. Additionally, 3PLS that operate facilities or provide services across multiple states will likely need to apply for licenses in each state where they serve.

Maintaining Compliance

After licenses are obtained, 3PLs should turn their attention to the ongoing requirements associated with licensure. In most states 3PL licenses must be renewed annually, although a handful of states require biennial renewal. State-issued controlled substance registrations must also be renewed, often annually or biennially.

There are also ongoing federal requirements for 3PLs. DEA-issued controlled substance registrations must be renewed and, under the Drug Supply Chain Security Act (DSCSA), 3PLs are required to submit annual licensing reports to the U.S. Food and Drug Administration (FDA).

In addition to these structured renewal events, 3PLs must also report address, contact information, and ownership changes as they occur. States typically require these types of changes to be reported within 10 or 20 days of their occurrence. In cases where a single business entity operates multiple facilities, the license for each facility must be updated when entity information changes take place.

Keeping up with each state’s requirements, tracking renewals, and submitting the applications on time are critical to avoiding penalties. Dedicated compliance services and software can help you keep track of varying jurisdiction requirements and relevant updates to state laws.

Explore Licensing by State

Click on a link below to view licensing information in your state.