New Mexico Broadens Pharmaceutical Licensing Requirements

New Mexico Broadens Pharmaceutical Licensing Requirements

Following the passage of Senate Bill 271 on June 14, 2019, The New Mexico Board of Pharmacy requires drug manufacturers, outsourcing facilities, repackagers, and third-party logistics providers to register for licensure and obtain a surety bond. Previously, the legislation only required non-resident pharmacies and wholesale drug distributors to obtain a surety bond. The purpose of these new surety bond requirements is to further regulate the industry and to ensure that all of these pharmaceutical companies are held to financial standards with the Board of Pharmacy. This will guarantee that all fees and penalties are paid to the state on time.

Who does New Mexico Senate Bill 271 affect?

New Mexico’s updated legislation requires the following types of companies to be licensed and registered with the Board of Pharmacy:

  • Drug manufacturers: includes the production, preparation, propagation, conversion or processing of a drug or device. This also includes the preparation and promotion of commercially available products from bulk compounds for resale
  • Outsourcing facilities: a facility at one geographic location that engages in the compounding of sterile drugs and is registered with the Food and Drug Administration
  • Third-party logistics providers: a person that provides or coordinates warehousing and other logistics services on behalf of a manufacturer, wholesale distributor, or dispenser of a product for which the person does not have ownership
  • Repackagers:  a person that repackages a drug, including medicinal gas, and has a valid registration with the FDA

What is the licensing process for pharmaceutical companies in New Mexico?

Before drug manufacturers, outsourcing facilities, repackagers, and third-party logistics providers can operate a facility in New Mexico, they must be licensed. The application for licensure must include the following information and documentation:

  • Name and address of the business
  • Name and address of the owner, partner, or director of retail pharmacy (if applicable)
  • Type of business to be conducted
  • Drawing of the floor plan of the location to be licensed
  • Proposed days and hours of operation
  • A surety bond in an amount determined by the Board of Pharmacy

How much does a pharmacy bond cost?

The specific bond amount for a pharmaceutical company will be determined by the New Mexico Board of Pharmacy. Because the amounts of the surety bonds vary, the premium applicants must pay will also vary. Whether it is a surety bond for a drug manufacturer or an outsourcing facility, the amount of the surety bond will be between $25,000 and $100,000. These bonds are issued for a one-year term and must be renewed annually for as long as the licensee wishes to keep their license active.

Why is a pharmacy bond required?

The board requires pharmaceutical companies to be bonded as a means of security and to ensure financial compensation as a result of unlawful acts conducted by a repackager, a third-party logistics provider, an outsourcing facility, or a drug manufacturer.

A surety bond is required for those renewing their license as well as new applicants. The expiration date of a license is established on a case-by-case basis by the Board of Pharmacy. It is also important to note that a company does not need separate surety bonds for separate locations, meaning a single bond will cover multiple locations.

Ready to get a surety bond for your pharmaceutical company?

The experts at SuretyBonds.com have years of experience issuing surety bonds nationwide, meaning they can get you a surety bond for your pharmaceutical company while saving you time and money. Apply for your bond online in minutes or call 1 (800)308-4358 for answers to any questions you have about surety bonds.

About the Author

Emma Winschel
Emma is a senior at the University of Missouri studying Business Administration with an emphasis in Marketing. She is a member of the marketing department and outreach team for SuretyBonds.com, a leading provider of online bonding for clients nationwide.