Pharmacy DEA Compliance: Is Your Pharmacy DSCSA Compliant?
Ensuring Compliance with Drug Supply Chain Security Act (DSCSA)
The safety and security of prescription drugs that are distributed in the United States is of utmost importance to ensure that patients receive effective treatments. In 2013, the U.S. passed the Drug Supply Chain Security Act (DSCSA) to regulate all companies involved in any aspect of pharmaceutical manufacture, distribution, or sale, including pharmaceutical companies, wholesalers, repackagers, and dispensers. These entities are required to have operational systems that allow for tracking and tracing of prescription medications at every point throughout the supply chain. Maintaining DSCSA compliance is crucial for pharmacies since non-compliance could result in hefty fines or even revocation of their license to operate.
At Spodek Law Group, we understand the significance of adhering to DSCSA regulations and how it impacts your business. Our team includes experienced attorneys that specialize in handling cases related to DSCSA regulations. We can support you in taking the necessary measures for compliance with a deep understanding of the law on this subject matter. Attorney Todd Spodek has established himself as an expert in resolving cases relating to various regulatory compliance matters for businesses; he can do the same for your pharmacy.
For pharmacies looking to become more fully compliant with requirements under DSCSA, several tools can facilitate this process:
Guidance Documents from FDA
The Food and Drug Administration (FDA) provides detailed guidance documents explaining requirements under DSCSA.
DSCSA Compliance Checklist from NCPA
The National Community Pharmacists Association (NCPA) offers a comprehensive compliance checklist if you’re aiming to assess how ready your pharmacy is for new DSCSA guidelines.
Pharmacy Verification System (PVS)
Checking unique product identifiers (UPIs) present on each prescription drug is vital when it comes down to remaining compliant with legislation. The Pharmacy Verification System (PVS) is a valuable online tool all pharmacies can use to verify UPIs before dispensing any prescription medications.
Pharmacy DSCSA Compliance Kit from RxSafe
If you’re looking for an all-in-one solution covering everything you need to ensure compliance with DSCSA regulations, the Pharmacy DSCSA Compliance Kit from RxSafe is an excellent option. An expert in delivering products and services meant for pharmaceutical companies – this complete turnkey solution includes a PVS subscription, barcode scanner, and other supporting software applications.
DEA Regulations and Compliance
Beyond the importation, creation or distribution of controlled substances lies the responsibilities of the Drug Enforcement Administration (DEA) enforcing regulations that focus on said matters. It is essential pharmacy owners register their establishments with the agency and ensure they maintain compliance with these demands. Failure to adhere to DEA regulations comes with severe civil or criminal consequences such as substantial fines or imprisonment.
Ensuring your pharmacy’s full compliance with DEA standards for your legal protection is crucial. Firms like Spodek Law Group can support you by providing expert assistance when it comes down to assessments of your establishments’ compliance levels and representing you if accused of violating any DEA regulations.
The Controlled Substances Act (CSA)
The CSA regulates drug production, importation, possession, use, and distribution according to federal law while dividing controlled substances into five schedules ranging from Schedule I (most restrictive) to Schedule V (least restrictive). The Drug Enforcement Administration (DEA) possesses power over continuum scheduling based on factors such as medical notion criteria of worthlessness; dependency level; abuse potential along with control considerations ensuring safety.
The following are some critical regulatory parameters set forth by the DEA that pharmacies must conform with:
Pharmacies that dispense controlled substances must be registered with the DEA regularly.
Pharmacies must perform regular inventory checks at least once every two years for all controlled substance stocks present within their premises.
Pharmacies may only dispense controlled substances to patients with a valid prescription provided by licensed practitioners.
Pharmacies must keep records of all controlled substances received, stored, and dispensed for at least two years. Such records must be readily accessible to DEA agents upon request.
Non-compliance carries significant consequences including substantial fines for businesses or even imprisonment in some cases.
Penalties for non-compliance with DEA regulations can be costly since they might result in hefty deposits ranging up to $10,000 per infraction in civil cases. Criminal repercussions like monetary penalties or years behind bars depending on the severity of accusations may also be awarded. If you find yourself encountering allegations involving DEA regulations in your establishment, it is wise to begin legal representation consultation as soon as possible.
The Spodek Law Group has exceptionally capable attorneys experienced in assisting individuals navigate DEA regulatory compliance issues; we offer robust defense strategies that guarantee minimal disruption during prosecution period’s business operations continuity. By ensuring our clients understand federal substance regulation charges against them and providing concise guidance on the relevant legal processes’ specifics, we assist businesses seeking full compliance through well-informed recommendations.
Contact us today for a consultation and allow us to become your ideal partner in navigating regulations related to controlled substances or otherwise.
NEW JERSEY CRIMINAL DEFENSE ATTORNEYS