The active maintenance of licenses, certifications, registrations and authorizations is a crucial element differentiating regulatory compliance at reputable pharmaceutical logistics services providers.
With patient health in the balance, multiple levels of government and other industry authorities require strict adherence to regulations, standards and practices.
LICENSING AND REGISTRATION
WDSrx is registered in every U.S. State that requires licensing for pharmaceutical Third Party Logistics companies and with the U.S. Food and Drug Administration (FDA) for prescription medications, medical devices, product repackaging and relabeling. WDSrx is also registered by the U.S. Drug Enforcement Administration (DEA) and relevant State authorities as a Reverse Distributor enabling regulatory compliant product disposition and also as an Importer and Exporter of Controlled Substances.
Supplemental credentials from Federal and National authorities including the FDA, CTPAT, TSA, DEA, DOT and EPA reinforce WDSrx capabilities. Several WDSrx facilities are recognized with NABP Drug Distributor Accreditation administered by the National Association of Boards of Pharmacy, a national trade organization. NABP Accreditation is earned by facilities that prevent counterfeit or diverted product from entering the supply chain. To support this mission, WDSrx complies with the Drug Supply Chain Security Act that legislates enhanced tracing of prescription drug products through the pharmaceutical supply distribution chain.
The licensing process may involve comprehensive facility inspections, background checks, documentation of adherence to Good Distribution Practices (GDP) and mandatory reporting requirements, third party verification and other conditions.
The penalties for non-compliance can be severe, with fines and disciplinary actions that can jeopardize continuing business operations. For this reason, at WDSrx licensing compliance is the daily responsibility of the company President Adam Runsdorf.
Regulatory compliance requirements involve all operations at WDSrx. Orders for highly regulated Controlled Substances must be recorded by the Controlled Substances Ordering System (CSOS) program overseen by the DEA. Transactions requiring movement of Controlled Substances to authorized trading partners must be filed in the Automated Reports and Consolidated Orders System (ARCOS) to assist the DEA to identify potential illicit drug diversion.
An experienced Quality Assurance and Regulatory Compliance department actively monitors WDSrx operations to assure proper training and adherence to regulations. Company procedures conform to ISO 13485 for medical devices and ISO 9001 for Quality Management Systems. The dedicated WDSrx Information Technology team oversees maintenance and security of validated computer systems that transmit, receive and store data in compliance with FDA Code of Federal Regulations 21 CFR 11.
Manufacturers utilize multiple compliance solutions managed by WDSrx to increase productivity. Government pricing programs require registration and accurate record-keeping to streamline financial accounting. Assuring compliance with contract payment terms, rebates and discounts between manufacturers and their customers requires robust chargeback processing administration. Product sampling programs managed by WDSrx are only undertaken with strict adherence to the Health Insurance Portability and Accountability Act (HIPAA) to assure confidentiality of proprietary information and the Prescription Drug Marketing Act (PDMA).
Industry leading pharmaceutical compliance services at WDSrx also benefit manufacturers of dietary supplements, animal health and personal care products. Progressive manufacturers in these industries appreciate the higher level of compliance available at WDSrx because it meets their customer expectations for supply chain transparency. Today’s informed consumers demand that premium brands they support use superior ingredients in their products, store them in a highly secure, temperature-controlled GMP warehouse and deliver them to their door safely and efficiently.
Regulatory compliance at WDSrx is a virtual shield providing confidence for manufacturers and their patients assuring safe and efficient movement of medications within the pharmaceutical supply chain.
For further information about regulatory compliance contact Larry Hotz (561) 998-3885 x304 or email@example.com