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Online Purchasing Regulatory Requirements & Documentation

To ensure compliance with state and federal regulations, specific documentation and regulatory requirements must be met for the sale of certain products on our platform.  Below is a summary of the regulatory requirements and the necessary documentation to be completed that can be returned to us by email.

1. Drug Enforcement Administration (DEA) Regulated Products

  • List 1 Chemicals – Applies to products containing chemicals used in illicit drug manufacturing and can only be sold to customers with established accounts. Currently we are only licensed to sell Iodine; any other DEA List 1 chemicals, DEA regulated machines (pellet press/encapsulating), or DEA scheduled drugs cannot be sold by Fisher Scientific.
  • Iodine – Due to DEA regulations, customers purchasing Iodine must have a DEA Form on file matching both the shipping address and caller/buyer on each regulated order. These forms are valid for one year from the signing date. Iodine orders are manually reviewed and released if the documentation is on file or held for two weeks pending the completed form. If the form is not received, the order will be cancelled. For Iodine inquiries or for more information regarding the DEA Form, please contact Iodine@thermo.com providing your account number and/or order number. Sales of all Iodine containing products are currently restricted from shipping to California and Iowa.

For the Iodine DEA Regulations please visit https://www.ecfr.gov/current/title-21/chapter-II/part-1310/section-1310.07. Going to this link will take you to a site outside of fishersci.com. 

Contact Information

For any regulatory inquiries or submission of documentation, please contact our Regulatory Affairs team at: RegulatoryAffairs.CCG@thermofisher.com

  • RX Licensing Permit
  • Iondine Permit Form
  • PFAS Inquiries

For Alcohol Permit Inquiries, please contact: Regaffairs.Med-ProductSupport@thermofisher.com

 

For SDS Inquiries or to submit Go Green documentation please contact: EMSDS.RA@thermofisher.com

2. RX Regulated Products

Applies to prescription medical devices and certain healthcare products that are purchased and shipping to certain regulated states. To order these products, an RX form must be completed and sent in with either a valid license or with the waiver portion completed, verifying that the products will not be used for clinical or veterinary care purposes. For more information regarding the regulated shipping states, the RX Form, and for all general RX inquiries, please contact RXpermits@thermofisher.com.

3. California

  • Mercury: California has mercury restrictions related to products such as lightbulbs; therefore, we cannot sell Mercury regulated items into the state.

    For more information on IMERC Mercury, please visit
    https://newmoa.com/prevention/mercury/imerc/about.cfm. Going to this link will take you to a site outside of fishersci.com
  • Flammable cabinets: All flammable storage cabinets must have self-closing doors to be sold into the state of California. This requirement is part of the state's adoption of the International Fire Code (IFC) standards.
  • Pesticides: California Dept. of Pesticide Regulation: products deemed pesticides (prohibits/kills algae, mold, bacteria, or other live organisms) by the state of California must be registered with the Dept. of Pesticide Regulation prior to sale into the state.  If the supplier doesn’t have a valid registration, then the materials will be blocked from sale into the state.  Again, there will be a hard stop in place to prevent the sale.
  • For more information on Pesticide Regulation in California, visit https://www.cdpr.ca.gov/. Going to this link will take you to a site outside of fishersci.com.
  • Iodine: The state of California does not list a minimum concentration of iodine in their regulations. All sales of iodine require a 21-day pre-shipment notification. Thermo Fisher Scientific is not currently capable of meeting these requirements and are not licensed to sell any iodine containing products into the state of California.

4. Alcohol

The purchase of ethanol and alcohol-related products may be subject to federal restrictions, as well as regulations imposed by certain states and commonwealths. Entities wishing to purchase/use ethanol and alcohol-related products including tax-free alcohol must obtain a permit from the Alcohol and Tobacco Tax and Trade Bureau (TTB).

Regulations for purchasing ethanol/tax-free alcohol can vary significantly from state to state in the USA. States including Pennsylvania, Utah and Viriginia have stringent controls over the distribution and sale of ethanol/tax-free alcohol.

Licenses and/or permits may be required to place orders with Fisher Scientific.

All inquiries regarding alcohol permits should be directed to the Regulatory Affairs Product Support team at: Regaffairs.Med-ProductSupport@thermofisher.com

5. SDS – Safety Data Sheets

OSHA requires manufacturers and distributors to send Safety Data Sheets (SDS) to customers for any hazardous product. Employers are also required to have SDS available to any employee. SDS are sent once a year or whenever there is a significant revision, based on catalog number and account number. The preferred method of SDS distribution is via email, however, if no email address is provided, SDS will be mailed to the customer via USPS.  When possible, a group email box/email address is preferred over an individual email address, to maintain continuity. Any questions regarding SDS can be submitted to EMSDS.RA@thermofisher.com.

6. PFAS

The United States and several other countries have enacted or proposed legislation concerning the use of per- and polyfluoroalkyl substances (PFAS) in materials, products, and manufacturing processes. In response to this changing regulatory landscape and customer requests, Fisher Scientific is undertaking a supply chain outreach initiative to gather PFAS-related information for the products we distribute.

For inquiries related to PFAS, please contact the Regulatory Affairs team at: RegulatoryAffairs.CCG@thermofisher.com.

For more information on PFAS, please visit https://www.epa.gov/pfas. Going to this link will take you to a site outside of fishersci.com.

Documentation Process

  1. Order Entry: Enter all items and attempt to process the order. If regulatory requirements are met, the order processes normally.
  2. Regulatory Review: Orders flagged for regulatory review will be handled by the Regulatory team. Customers may be contacted for additional documentation if required.
  3. Customer Notification: If an order is rejected due to regulatory reasons, customers will be informed that the item cannot be supplied due to regulatory requirements.
  4. License Submission: For Rx items, customers must submit the License Acknowledgement Form and any required licenses to the designated email addresses. For Iodine purchases, the DEA Form must be completed and returned to release the order.

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