How to Become a Drug Distributor in the US

Becoming a drug distributor in the US is a complex process that requires obtaining a wholesale drug distributor license in the home state. This may involve filing an application, paying fees, providing copies of internal policies and procedures, and obtaining bonds. Depending on the state, approval times for a wholesale drug distributor license can range from weeks to months. Additionally, some states require background and fingerprint checks. To apply for and obtain drug distributor accreditation, a Drug Distributor (DR) must provide a detailed inventory similar to that required for the DEA 1304.22 for all complete drug packages and incoming prescription devices subject to accreditation.

The Department of Health provides technical assistance to its licensees, responds to consumer inquiries, and investigates complaints related to possible violations of state requirements for drug manufacturers and distributors. The law has evolved over time to include new requirements for a uniform licensing standard that would address the patchwork system of requirements for wholesale drug distributors across state lines. CT Corporation can help you overcome the uniquely complex licensing and regulatory challenges of wholesale drug distributors. After one year revocation due to failure to renew, any wholesale drug distributor whose license has been revoked for more than one year for failing to meet renewal requirements may reapply to the Department for a license. Prescription drug distributors must operate in accordance with the rules found in 25 Texas Administrative Code (TAC), Sections 229,419 - 229,430 - Licenses for Wholesale Prescription Drug Distributors; Including Good Manufacturing Practices. Every wholesale drug distributor doing business in Nebraska must be inspected on-site by the Department, by a nationally recognized accreditation program approved by the Board, or by another state or federal regulatory agency approved by the Board. In addition, businesses located outside of Texas that are engaged in the distribution of over-the-counter or prescription drugs in this state must obtain a license from DSHS as out-of-state distributors.

Virtual wholesale distributors are applicants who sell a prescription drug or device but never physically own the product. Prescription drug distributor inspections generally include an assessment of a distributor's compliance level with 21 CFR, Part 205.

Rachel Celli
Rachel Celli

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