pharmacy regulatory compliance

pharmacy regulatory compliance

Pharmacy Regulatory Compliance

Generally-speaking, regulatory compliance can be defined as adhering or conforming to a rule, standard, regulation, or law. In the healthcare setting, regulatory compliance has additional layers of complexity baked in that also include professional and ethical matters, given the nature of the services rendered in these fields.

Pharmacy regulatory compliance encompasses all pharmaceutical activities – everything from drug ordering/medication procurement, inventory management, billing practices for private and government payers, and drug security to medication and patient safety measures, prescription fraud monitoring, and professional credentialing. Virtually each task pharmacy professionals perform in any pharmaceutical setting is governed by rules, norms, standards, or laws that demand unwavering compliance. Any discovered non-compliance has the potential to cause major financial and operational setbacks to organizations of all sizes. What also complicates companies’ ability to consistently adhere to all rules and regulations is the reality that compliance itself is a moving target – governing agencies, oversight and advisory boards in charge of making and enforcing the laws can be slow to create accountability structures. Couple that with swiftly changing markets requiring new laws and rules to quickly supplant old ones…this is the genesis for why a healthy compliance program is a must. Making a commitment to fostering a culture of compliance from the start and investing in dedicated resources to ensure programmatic integrity saves companies a great deal of heartache and enables them to focus on their mission of providing high quality patient care.

Whether stand-alone independent retail pharmacies or pharmacies embedded in a Level 1 Trauma Center, pharmacy entities assume a great deal of responsibility for numerous state and federal regulatory and accreditation requirements. Traversing the maze of laws and regulations seems overwhelming and can be both time-consuming and expensive. Let us help you focus on what your business model’s individualized compliance needs are so you can build a strong foundation for optimizing operational performance and productivity.

Let us help you focus on what your business model’s individualized compliance needs are so you can build a strong foundation for optimizing operational performance and productivity. – Contact us today.

Licensing Assistance

We provide end-to-end licensing assistance, working on your behalf to complete and submit all required paperwork in an organized and timely fashion. We have found that establishing a project timeline highlighting milestones and key deliverables in sequential order helps our clients stay on track, reducing rework and costly delays in application and licensing processing time. Virtually every state, federal, and local regulatory agency carries different fee schedules, application requirements, approval turnaround times, and license expiration timelines. This variability is enough to cause even the most organized, proactive business to get tripped up and miss deadlines, which can create inadvertent noncompliance that leads to deleterious patient care impacts. You can rely on our trusted experts to manage your licensing needs from start to finish, particularly in the following specialized areas:

  • State license initial application and renewals for all 50 states + Washington, D.C. (retail, hospital, non-resident, sterile compounding, etc.)
  • Drug Enforcement Agency (DEA) registration and renewals
  • Obtain National Provider Identifier (NPI) number
  • Business entity registration and renewals – master business license, city licenses, obtaining employer identification number (EIN), business tax registration, workers’ compensation and unemployment insurance, annual report compliance, etc.

Inspection & Accreditation Readiness

Accurately completing and submitting required licensing/accreditation paperwork is a big accomplishment that will bring you one step closer to providing the enhanced patient care services you’ve been working to achieve. So what’s next? As a condition of obtaining a new license or accreditation as well maintaining this recognition, many regulatory bodies mandate initial onsite inspections and conduct routine scheduled (and sometimes drop-in) inspections. Given our team of consultants has enjoyed over a decade of success in seamlessly leading companies through numerous inspections that resulted in passing scores and on-time openings, we can help you be certain your dress rehearsal will ensure your real-time readiness. Some of our services include the following:

  • Conduct mock inspections from pertinent regulatory bodies (DEA, state boards of pharmacy, CDC, FDA, JACHO, DNV) – report out on findings with recommendations for correction
  • Provide on-site during scheduled inspections or on-call virtual support for unscheduled inspections
  • Create/maintain inspection toolkit and quick-reference compliance guide for staff

Additional Ad-Hoc Compliance Services

  • Confidentiality practices assessment
    We will conduct an enterprise-wide compliance evaluation to determine the integrity of patient privacy practices (HIPAA) within operations and software.
  • Pharmacy acquisition/transfer of ownership
    For companies in transitional phases of acquisition or ownership transfer, we provide expertise such as conducting a gap analysis on regulatory compliance from previous owner/entity, investigating disciplinary actions, diversion, or third party exclusions in effort to close out/resolve any outstanding inquiries for smoother data and ownership transfer.
  • Conduct on-site and/or virtual compliance audits
    Our team will review your company’s overall pharmacy compliance program and/or advise on establishing a robust compliance program that makes sense for your unique business needs. We will audit your policies and procedures and assess employee knowledge and competency to ensure teams understand compliance requirements and can confidently practice within those parameters.