New Mexico expands pharmaceutical licensing requirements

NEW MEXICO — The New Mexico Board of Pharmacy now requires drug manufacturers, outsourcing facilities, repackagers, and third-party logistics providers to be licensed and bonded.

While the law previously required only nonresident pharmacies and wholesale drug distributors to be bonded, Senate Bill 271 broadened regulations after passing in June 2019. These surety bonds provide security that all pharmaceutical companies listed are held to the board’s financial standards.

The Board of Pharmacy sets the amount of the surety bond, which varies. A company must obtain the bond as an initial applicant and renew the bond annually for as long as the company renews its license. The company does not need separate bonds for each location or for affiliated companies or groups.

Types of New Mexico Board of Pharmacy licenses that require surety bonds:

  • Wholesale Drug Distributor: a person engaged in the wholesale delivery of a drug or device, including own-label distributors, private-label distributors, jobbers, brokers, manufacturers’ warehouses, distributor’s warehouses, chain drug warehouses, wholesale drug warehouses, independent wholesale drug traders and retail pharmacies that conduct wholesale distribution
  • Wholesale Drug Manufacturer: a person engaged in the production, preparation, propagation, conversion or processing of a drug or device, either directly or indirectly, by extraction from substances of natural origin or independently by means of chemical or biological synthesis and includes packaging or repackaging, labeling or relabeling and the promotion and marketing of the drugs or devices
  • Nonresident Pharmacies: any pharmacy located outside New Mexico that ships, mails or delivers, in any manner, drugs into New Mexico
  • Outsourcing Facilities: a facility at one geographic location or address that engages in the compounding of sterile drugs, is licensed by the board and, in accordance with board rules, is currently registered with the United States Food and Drug Administration as an outsourcing facility
  • Repackagers: a person that repackages a drug, including a medicinal gas, and that, in accordance with board rules, has a valid registration as a drug establishment with the United States Food and Drug Administration
  • Third-party Logistics Provider: a person that provides or coordinates warehousing or other logistics services of a product in interstate commerce on behalf of a manufacturer, wholesale distributor or dispenser of a product but which person does not take ownership of the product nor have responsibility to direct the sale or disposition of the product

Source: New Mexico SB 271

Alpha Surety & Insurance Brokerage will be happy to answer any questions regarding a New Mexico surety bond or any surety bond questions in general. You can call 800-901-3099 or send an email through the contact us page. We are here to answer your questions and help you fully understand surety bonds regardless of whether you choose to bond with us.

 

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