Run a Compliant Pharmacy or Deal with Pharmacy Compliance Issues
Pharmacy Consulting Team Lead – Timothy E. Allen | Former Special Agent (U.S. Secret Service & DOJ-OIG)
Pharmacies are subjected to regulatory scrutiny globally. The scrutiny is focused on numerous areas from sales and marketing to drug price reporting, privacy of client health information and drug safety reporting. Other areas of scrutiny include quality control.
Compliance for pharmacies is a never-ending challenge as regulations change and the ever-increasing amount of data. Supply chain challenges are also becoming increasingly complex. Pharmacy owners also face complex regulatory challenges such as overlapping requirements across different sectors and jurisdictions.
That’s where Corporate Investigation Consulting comes in. Our work is making compliance easy for pharmacies doing business locally in the U.S. and internationally. Our compliance consulting service ensures competitive advantage as opposed to making compliance a bureaucratic duty.
DEA, FDA & EPA Pharmacy Compliance Guidelines
Pharmacies play a critical role (dispensing medication) in the U.S. drug supply chain. There are several regulators regulating pharmacies and other industry players. These regulators (state and federal) govern the operations of pharmacies with special focus on the security and safety of the public and other industry players.
Pharmacies must adhere to many laws dictating the management of hazardous waste and how controlled substances should be handled. These laws are enforced by three main agencies, namely, the DEA, EPA, and FDA.
Put our highly experienced team on your side
Roger Bach
Former Special Agent (OIG)
Timothy E. Allen
Former Senior Special Agent U.S. Secret Service
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Maura Kelley
Former Special Agent (FBI)
Ray Yuen
Former Supervisory Special Agent (FBI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Marquis D. Pickett
Special Agent U.S. Secret Service (ret.)
FDA (Food & Drug Administration) on Pharmacy Compliance
The FDA enforces a special Act known as the DSCSA which all pharmacies must comply with. This act highlights compliance guidelines that must be followed by pharmacies in regards to drug supply chains for the sole purpose of protecting patients from dangerous/harmful drugs.
As per the DSCSA, all pharmacies must confirm FDA registration and licensing of all entities they work with, have product tracing documentation, and respond to illegitimate or suspect drugs accordingly.
Are you familiar with every FDA guideline out there regarding pharmacies? If not, talk to expert pharmacy compliance consults at Corporate Investigation Consulting.
DEA on Pharmacy Compliance
The DEA (Drug Enforcement Agency) also has a say on how pharmacies do business in the U.S. Through the CSA (Controlled Substance Act), the DEA enforces compliance on how pharmacies handle, store and distribute drugs.
Pharmacies must comply with transfer and disposal guidelines i.e., get professional help when handling inventory, packing, transferring, and disposing of drugs.
Pharmacies must also take responsibility and act accordingly (notify law enforcement and the DEA) if controlled substances are stolen or lost in transit.
Pharmacies also need to comply with record-keeping guidelines, inventory guidelines, prescription guidelines, as well as ordering and dispensing requirements.
The DEA’s guidelines are incredibly complex. What’s more, lack of compliance can halt your operations and attract other unfavorable consequences such as hefty fines, pharmacy license cancelation and criminal charges. That’s precisely why you should leave all pharmacy compliance issues to true experts like Corporate Investigation Consulting.
EPA on Pharmacy Compliance
The EPA regulates pharmacies through the RCRA. Pharmacies must comply with what the RCRA says on managing hazardous & non-hazardous solid waste. Pharmacies are bound to generate hazardous waste when transporting, storing, and disposing drugs, among other operational processes. This waste must be handled as per the EPA’s guidelines.
Pharmacy compliance guidelines by the EPA touch on identifying hazardous waste generated, calculating total waste, notifying the EPA, managing the waste and transporting it to waste management facilities and/or recycling, treating and disposing waste.
Keeping up with compliance obligations with the DEA, FDA & EPA alone is a time-consuming and challenging task, yet pharmacy compliance obligations don’t end with these three agencies.
Trade Compliance
Pharmacies must be compliant in many other issues. FDI (Foreign Direct Investments) in the pharmaceutical industry comes with national security concerns. Sanctions can affect pharmaceutical companies operating globally. Such companies need global trade compliance expertise when sourcing inventory and other dealings with global companies.
Pharmacy chains operating globally need to navigate sanctions, multi-national regulations, and many other trade restrictions such as those placed by the CFIUS.
Corporate Investigation Consulting has extensive expertise on trade compliance and related issues capable of helping pharmaceutical clients navigating complex sanctions and other global trade compliance issues.
We do country-specific compliance assessments on sanctions and other global trade compliance issues and advise pharmaceutical companies with global operations on how to conduct businesses in different countries. We also offer compliance consulting services on global distribution channels.
Big Data Compliance
Data proliferation introduces complex problems, especially among companies operating globally with intricate structures. Corporate Investigation Consulting has technology solutions and experienced cybersecurity experts that offer global entities visibility and unmatched control over business info while still ensuring data protection compliance.
We understand important data protection compliance laws like the GDPR and have the capacity to create data compliant global pharmaceutical operations. We have experts who’ve spent decades in the most challenging global jurisdictions for pharmacies. We understand how to establish compliance departments and a compliant culture in your organization to handle global pharmacy compliance demands from global regulators and businesses.
Our Pharmacy Compliance Consulting Advantage
You should seek our pharmacy consulting services because of the following:
Our Scope: We can investigate and resolve all pharmacy compliance issues locally and globally besides consulting on government agency guidelines, trade compliance and data compliance. We offer compliance assessments and advice clients on how to handle individual circumstances. Our services extend to implementing compliance guidelines following investigations, developing internal controls, auditing and testing current compliance processes, and facilitating training of employees and third parties.
Compliance consulting for all: We work with big, medium-sized, and small pharmacies. Call us at 866-352-9324. Our service can help you avoid criminal charges or get such charges dismissed.
Global experts in pharmacy compliance: Our experts know all there is about pharmacy compliance, from regulator laws to data compliance and regulations affecting global pharmaceutical chains. We have legal experts, cybersecurity experts, strategy consultants, former intelligence officers, and other professionals in our team ready to assist you meet all your pharmacy compliance obligations.
What’s more, we offer the best and most cost-effective approach to monitoring, testing, enhancing, or creating new pharmacy compliance programs.
Let Corporate Investigation Consulting deal with potential compliance threats and possible law violations that can tarnish your pharmacy’s brand, financial viability, and business relations.
Get a free-non-obligatory pharmacy compliance consultation now! Call us at 866-352-9324, or fill our online form to get help on all matters regarding pharmacy compliance in the U.S. and beyond.