Medvantx Quality and Compliance for Controlled Substances


Medvantx Controlled Substances Operations Deliver Trust and Excellence 

As a pharmaceutical manufacturer, you know how crucial it is to ensure the safety, quality and compliance for controlled substance medications that are dispensed to patients. You also know how complex and challenging it can be to manage controlled substances, which require special attention and care throughout the supply chain lifecycle. Medvantx has developed a robust and reliable process for our controlled substances operations and flow, from order entry to delivery. In this blog, we will walk you through the steps of our process and show you how we deliver excellence and trust to our manufacturer and HUB partners, and, to the patients who need these medications.  

At Medvantx, we are committed to providing high-quality, safe, and secure delivery of controlled substance medications to patients across the United States. Our services and capabilities include:  

  • API integrations with manufacturers and HUB partners for receiving orders and ensuring chain of custody, while receiving controlled prescriptions directly from the prescriber. 
  • HCP communication via Electronic Rx, faxes, calls to verify enrollments and prescriptions, and data feed  to Guardian Rx. 
  • Pharmacist verification of orders, prescriptions, patient-prescriber relationships, and appropriateness of therapy. 
  • Production technician pick, pack, and ship orders using barcode technology with tamper-evident packaging. 
  • Pharmacist fulfillment verification, some medications including a double count process, or count-back and tracking perpetual inventory for controlled substances. 

Order Entry/Intake 

Our process begins by receiving the order from the manufacturer or the HUB partner’s HCP. We use API integrations to make this process faster and more accurate, avoiding mistakes and delays to the patient receiving the medication. Depending on the type of medication, healthcare providers can contact Medvantx via Electronic Rx, fax, and phone calls to provide prescription details. Pharmacists verify any Rx and ensure the prescription has met qualifications and is received in the appropriate format for processing, according to state and federal law. We also make sure that there is a valid relationship between the patient and the prescriber and that the therapy is suitable for the patient’s condition. We synchronize the required information, to interface with our pharmacy platform, Guardian Rx, where the order is set for pharmacist verification.  We keep records of receiving, dispensing, disposal, and inventory in line with state and federal FDA requirements while also ensuring DSCSA-compliant inventory procedures, and DEA requirements be met. 

Pharmacist Order Verification (PV1) 

The second step of our process is to have a pharmacist verify the order through Guardian Rx. The pharmacist reviews the order for any existing prescription interaction, duplication of therapy, or inappropriate dosage. The pharmacist also checks the patient’s medical history, allergy profile, and diagnosis. If there are any issues or concerns, the pharmacist contacts the prescriber or the patient to clarify and resolve them. The pharmacist then approves the order and sends it to production.  

Production Tech Order Pick 

The third step of our process is to have a production technician print the prescription labels and move the prescribed medication from inventory to the production station. Here we use barcode technology to scan and track each product, ensuring accuracy and traceability. We also have safeguards against picking quarantined or soon-to-expire inventory, which are flagged and removed from circulation. For applicable controlled substances, we store and pick them from a restricted access location, where only authorized personnel can access them. We follow the CSOS protocol for ordering and receiving controlled substances from the manufacturer, and we maintain state and federally-compliant records for every transaction. 

Pharmacist Fulfillment Verification (PV2) 

The fourth step of our process is to have a pharmacist physically confirm that the medication is ready to be packed as prescribed. The pharmacist scans the barcode of the product and compares it with the prescription label, verifying the NDC, serial number, lot number, expiration date, and quantity. For applicable controlled substances, we use a double-count process, where two pharmacists independently count and confirm the number of units. We also use a perpetual inventory system, where we update the stock level of each controlled substance after every transaction. This ensures that we have accurate and real-time records of our inventory, and that we can detect and prevent any discrepancies or diversions. 

Production Tech Order Packing 

The last step of our process is to have a production technician pack the order for delivery. The technician packs the envelope, box, or corrugated cooler (if cold-chain) with the necessary pamphlets, medication, and printouts maintaining adherence with FDA standards. We use a triple scan insertion process, where we scan the barcode of each product, the packing slip, and the shipping label, ensuring that the correct items are packed and shipped. If the product is a cold chain, we also include temperature sensors, cool gel bricks, and insulated packaging to maintain the optimal temperature range throughout the transit process. We use tamper-evident packaging with no markings, to protect the privacy and security of the patient and the product. We then ship the order via our preferred courier service, providing tracking information and delivery confirmation to the patient and the prescriber. 

Order Shipment 

The final step of order fulfillment is  order shipment. Medvantx monitors the shipment of every order from our facility to the patient’s doorstep. We conduct daily checks for quality assurance, tracking the temperature, location, and status of each package. We also require signature capture by the patient and/or provider upon receipt of delivery, to verify that the order has reached the intended recipient, and that the product is in good condition. This way, we can ensure that our controlled substance  operations and flow meet the highest standards of compliance, security, and customer satisfaction. 

Medvantx maintains a robust and compliant controlled substance  operation and flow, that ensures the safety, quality, and efficiency of our services. We are proud to partner with manufacturers and HUBs to deliver the best possible care to patients across the United States.  

If you are looking for a reliable and trusted partner to manage your controlled substances , then Medvantx is the right choice for you. We have the expertise, technology, and infrastructure to manage your specialty pharmacy needs with excellence and integrity. Whether you need API integration, patient verification, pharmacist review, order fulfillment, or shipment tracking, we have the solutions for you. Contact us today to learn more about how we can help you deliver better outcomes for your patients and your business. 

“At Medvantx, we put safety and quality first in everything we do. That means we adhere to the highest standards of compliance and security for our controlled substanceoperations and workflow. We monitor every step of the process, from API integration to shipment tracking, to ensure that our products are delivered safely and efficiently to the patients who need them. We are not just a pharmacy; we are a partner in care.” 

– Samira, VP of Medical Affairs at Medvantx


To connect with Medvantx, please reach out to our sales team here.


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