Regulatory Compliance

InstyMeds has been successfully dispensing medications directly to patients in the United States since 2001. In the US and around the world prescription dispensing is one of the most heavily-regulated industries. While dispensing regulations vary state-by-state and country-by-country, they all tend to be very thorough and cover the entire chain of activities from the placement of prescription orders to the dispensing of medications to patients including:

  • Who can write a prescription
  • Who can dispense a prescription
  • Who can fill a medication container
  • Who can label a medication container
  • Who can counsel a patient

2001

FIRST DISPENSE TO A
PATIENT IN MINNESOTA

InstyMeds has partnered with regulatory authorities, including state Boards of Pharmacy, state medical boards, the Drug Enforcement Agency, and the Food and Drug Administration, to develop the safest and most secure system ever designed that meets or exceeds regulatory requirements in the jurisdictions we operate in.

The InstyMeds Medication Adherence System is designed to include the following regulatory compliance features and services:

  • InstyMeds and its subsidiaries hold many licenses and accreditations including VAWD certification and wholesale distribution licenses in almost all US states.
  • We help our customers comply with regulatory requirements such as PDMP¹ reporting by automatically filing PDMP reports in every state.
  • InstyMeds is compliant with the serialization requirements of the 2013 Drug Supply Chain Security Act (DSCSA).²
  • InstyMeds procures pedigree drugs from leading drug wholesale distributors.
  • Every medication bottle dispensed by InstyMeds has a state-approved patient label on it.
  • We offer the most technically-advanced drug expiration and recall management system in the world.  Our dispensers simply CANNOT dispense an expired or recalled medicine.

Processing of Recalled Medications at InstyMeds

1

InstyMeds is notified by a manufacturer of the product batch and lot numbers affected by a recall

2

InstyMeds pharmacist immediately enters this information into the InstyMeds enterprise software

3

The recalled medication is instantly deactivated and prevented from being dispensed in the InstyMeds system worldwide

Today InstyMeds operates in most states in the US and on two other continents.  With over 18 years of dispensing experience InstyMeds is the leading authority on point-of-care dispensing and point-of-care dispensing regulations in the marketplace.

Click Here

to contact us with regulatory questions

1 A prescription drug monitoring program (PDMP) is an electronic database that tracks controlled substance prescriptions in a state.

2 Drug Supply Chain Security Act, Pub Law Na.113-54, 127 Stat 599 (2013).