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The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to help ensure the safety and security of prescription drugs distributed in the U.S. The DSCSA requires pharmaceutical companies, wholesale distributors, repackagers, and dispensers to implement systems and processes that track and trace prescription drugs as they move through the supply chain.
The DSCSA also requires pharmacies to verify that each prescription drug they receive has a unique product identifier (UPI). The UPI is a 2D barcode or RFID tag that contains information about the drug’s manufacturer, lot number, expiration date, etc. Pharmacies must scan or read this code before dispensing a prescription drug to a patient.
If your pharmacy is not already compliant with the DSCSA, you need to take action now. Non-compliant pharmacies face significant fines and could even lose their license to operate.
Here are some resources to help you get started:
The FDA has published guidance documents that explain the DSCSA requirements in detail.
The National Community Pharmacists Association (NCPA) offers a DSCSA compliance checklist that you can use to assess your pharmacy’s readiness.
The Pharmacy Verification System (PVS) is an online tool that allows pharmacies to verify the UPIs of prescription drugs.
The Pharmacy DSCSA Compliance Kit from RxSafe is a turnkey solution that includes everything you need to comply with the DSCSA, including a PVS subscription, barcode scanner, and software.
Don’t wait – get your pharmacy compliant with the DSCSA today!
The Drug Enforcement Administration (DEA) is a federal law enforcement agency under the U.S. Department of Justice that is responsible for enforcing the Controlled Substances Act, which regulates the manufacture, importation, possession, use and distribution of certain drugs. The DEA also enforces other laws and regulations related to controlled substances.
If you are a pharmacist or pharmacy owner, it is important to ensure that you are in compliance with all DEA regulations. Non-compliance can result in civil or criminal penalties, including fines and imprisonment. A pharmacy DEA compliance lawyer can help you ensure that your pharmacy is in compliance with all DEA regulations and can represent you if you are accused of violating any DEA regulations.
What is the Controlled Substances Act?
The Controlled Substances Act (CSA) is a federal law that regulates the manufacture, importation, possession, use and distribution of certain drugs. The CSA is divided into five schedules, with Schedule I being the most restrictive and Schedule V being the least restrictive.
The CSA gives the DEA the authority to add, remove or transfer drugs between schedules based on factors such as a drug’s potential for abuse, its medical use and its safety or dependence liability.
What are some DEA regulations?
DEA regulations are found in Title 21 of the Code of Federal Regulations (CFR). Some of the DEA regulations that apply to pharmacies include:
-Registration: Pharmacies must be registered with the DEA in order to dispense controlled substances.
-Inventory: Pharmacies must take inventory of all controlled substances at least once every two years.
-Dispensing: Pharmacies can only dispense controlled substances pursuant to a valid prescription from a licensed practitioner.
-Record keeping: Pharmacies must keep records of all controlled substances received, stored and dispensed. These records must be kept for at least two years and must be readily available for inspection by DEA agents.
What are the penalties for violating DEA regulations?
Violations of DEA regulations can result in civil or criminal penalties. Civil penalties can include fines of up to $10,000 per violation. Criminal penalties can include fines and imprisonment.
If you are accused of violating DEA regulations, you should contact a pharmacy DEA compliance lawyer as soon as possible. A lawyer can help you understand the charges against you and can defend you against the charges.
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