Distributing Compounded Drugs to Colorado Veterinarians

In late 2017, the Colorado Board of Pharmacy (Board) sent notice to all facilities registered with the Board as nonresident pharmacies. The notification addressed the distribution of medications into Colorado. The notification states, in part, the following:

“Colorado law and Board rule (CRS 12-42.5-118.5 and Board Rules 21.00.20(d)) allow a nonresident pharmacy (“Pharmacy”) to distribute a compounded product to a Colorado licensed veterinarian who is located in Colorado and authorized by law to prescribe the drug only if:

  1. The Pharmacy annually provides the Board with a copy of the pharmacy’s most recent report detailing an inspection by the National Association of Boards of Pharmacy Verified Pharmacy Program. The Pharmacy is responsible for the costs associated with this inspection. The Board must approve this inspection report as satisfactorily demonstrating proof of compliance with Colorado’s own inspection procedures and standards prior to distributing compounded veterinary products into Colorado;
  2. The Pharmacy annually provide the Board with a copy of the most recent inspection from the Board in which the pharmacy resides. The Board must approve this inspection report as satisfactorily demonstrating proof of compliance with the Colorado’s own inspection procedures and standards prior to distributing compounded veterinary products into Colorado; and
  3. The Pharmacy must annually provide the Board a copy of the outlet’s current manufacturer registration obtained from the Drug Enforcement Agency.”

All nonresident pharmacies were asked to complete an affidavit to confirm that their business is aware of the Colorado law and that they will not distribute such products in violation of the Colorado law and Board rules as cited above. The Board is requesting that the affidavit be signed and returned to the Board no later than January 31, 2018. Failure to do so will result in a complaint filed against the nonresident pharmacy.

As of late May 2018, the Board initiated complaints against hundreds of non-resident pharmacies that failed to complete the affidavit.

Under Colorado law, “distribution” means the transfer of a drug or device other than by administering or dispensing. (CRS 12-42.5-102(12)).

“Dispense” means “to interpret, evaluate, and implement a prescription drug order or chart order, including the preparation of a drug or device for a patient or patient’s agent in a suitable container appropriately labeled for subsequent administration to or use by a patient. (CRS 12-42.5-102(11)).

If you have any questions regarding the distribution of compounded medications into Colorado, please do not hesitate to contact Baer Law immediately.