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What is Pharmacy Law?

As the realm of pharmacy continues to evolve and expand, more and more regulations are introduced. Federal and state agencies are tasked with licensing pharmacies, wholesalers, manufacturers and pharmacists. Each licensed entity must stay abreast of the ever-changing federal and state regulatory rules to ensure they remain in compliance with all applicable pharmacy practice laws. One misstep can result in catastrophic consequences. While licensing requirements vary enormously from one federal or state agency to another, a discipline by one state or agency can easily result in a cascade of fines or disciplines. With such stringent rules, regulations and licensing requirements, many of the pharmacies, wholesalers, manufacturers and pharmacists seek out pharmacist attorneys who are well versed in pharmacy rules and regulations.

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A Pharmacy Focus

You see might see them counseling patients or providing immunizations at your local pharmacy or even rounding with nurses and physicians at a hospital or nursing home, but, truth be told, pharmacists are highly trained medication experts – doctors of pharmacy – who practice in nearly all areas and specialties in healthcare, many times behind the scenes. As arguably the most accessible of all health care providers, pharmacists educate patients on the use of prescription and over-the- counter medications, optimize medication therapies, collaborate with nurses and physicians on medication therapy decisions and, as medication experts, ensure each patients’ health, wellness and safety are a top priority. When a pharmacist or pharmacy is accused of malpractice or faces discipline, they need the assistance or guidance from professionals well versed in pharmacy law - pharmacist attorneys.

Pharmacist Licensure Defense

Pharmacists, the medication experts, are one of the most accessible members of the health care team and they play a vital role in preventing medication errors and ensuring patient safety. Pharmacist attorneys are all too familiar with a pharmacist’s impact on patient safety since, as licensed pharmacists, they took an oath that includes, in part, the following: “I will apply my knowledge, experience and skills to the best of my ability to assure optimal outcomes for my patients.”

With their intimate, first-hand knowledge of the practice of pharmacy, pharmacist attorneys are best positioned to thoroughly understand how pharmacists’ impact patient safety and strive to ensure optimal outcomes by routinely assessing patients’ health status, providing treatment guidance and assessing the effectiveness of medication therapy for its appropriateness.

When a pharmacist deviates from the standard of practice and places patient safety at risk, the pharmacist is often disciplined, fined or subject to accusations of malpractice. Responding to such actions and accusations is often a recipe for disaster, and even the most highly educated and well-respected pharmacists seek out the guidance of pharmacist attorneys – experts in their field of practice. Pharmacist attorneys, familiar with pharmacy protocols and processes and the state and federal rules and regulations, are able to thoroughly understand the accusations and related legal issues and, then promptly address them all while providing expert guidance.

Experts in their Field

Pharmacists spend countless hours learning their profession – from their required time in the classroom completing their doctor of pharmacy degree to hands-on- training as a pharmacy intern and then the on-the- job training as a licensed pharmacist. Pharmacist attorneys are no different. They are unique positioned to provide their clients with expert pharmacy law knowledge based on their experiences working as a pharmacist and a attorney. From a simple consultation or case review to a providing lengthy representation, a great pharmacist attorney is an invaluable asset for clients licensed as pharmacists, pharmacies, wholesalers and manufacturers.

Pharmacy Law Service Highlights

If a pharmacist, a pharmacy, a wholesaler or a manufacturer has an issue, pharmacist attorneys, experts in the field of pharmacy law, will, after reviewing applicable rules and regulations, find answers to complex problems, no matter how seemingly small or overwhelmingly large the  problem may be.

But what makes pharmacist attorneys so valuable to their clients? Pharmacy law services are quite broad and can range from defending pharmacists, pharmacies, wholesalers or manufacturers from federal and state administrative complaints or investigations, managing and mitigating regulatory and governmental compliance issues, dealing with malpractice issues where patients have been injured, and so much more:

Federal & State Regulatory Issues

Pharmacist attorneys routinely advise clients on ever-changing laws and regulations passed by federal and state agencies that affect the entire pharmacy industry.

DEA Compliance

The DEA conducts regular audits of pharmacies, manufacturers and wholesalers. Failure to stay abreast of the current DEA rules and regulations can result in disciplinary actions, fines and loss of licensure. Highly specialized pharmacy law attorneys can help prevent compliance issues from arising or mitigating those that do.

FDA Regulatory Issues

Much like the DEA, the FDA also has a vested interest in ensuring all pharmacy rules and regulations concerning prescription and over-the- counter drugs are followed. Pharmacy law specialists know these regulatory issues inside and out.

Regulatory Counsel for Pharmacies, Manufacturers and Wholesalers

Pharmacy law attorneys act as legal counsel for pharmacies, manufacturers and wholesalers to ensure these clients comply with all applicable state and federal rules and regulations.

Responses to Regulatory Inquiries and Investigations

A pharmacist or pharmacy receiving a notice of investigation or a regulatory inquiry may not possess the legal knowledge to respond appropriately. Pharmacy law attorneys who routinely work directly with federal and state licensing agencies can respond to such investigations and inquiries on behalf of their unique clients.

Licensing new pharmacy locations

Opening a pharmacy requires dealing with a mountain of red tape, as these locations must have the proper licensing and be in compliance with an abundance of federal and state rules. Pharmacy law attorneys are intimately familiar with this licensure process and can save their clients valuable time and money.

Advising Pharmacies on Staffing, Operational and System Requirements

Operating a successful pharmacy goes further than simply ensuring the business itself is licensed. There are an abundance of legal standards that must be maintained when it comes to managing staff and the pharmacy’s day-to- day operations – and pharmacy law attorneys can help plot a course through these murky waters.

Pharmacy Licensing and Reporting Requirements

Every state has different licensing and reporting requirements when it comes to operating a pharmacy, manufacturer or wholesaler. Additionally, the federal government’s licensing and reporting requirements also need to be met. Relying on a pharmacy law attorney ensures that none of these requirements go unfulfilled.

HIPAA and State Privacy Laws

Patient privacy is highly regulated. Even the most innocent misstep can expose a pharmacist or pharmacy to dire consequences – up to and including the relinquishment of their licensure. Pharmacy law attorneys can provide invaluable guidance on HIPAA issues.

Assist Clients with State Board Inquiries, Reporting Requirements, Controlled Substance Requirements and Prescription Requirements

Pharmacists, pharmacies, wholesalers and manufacturers continue to be inundated with new rules and regulations and reporting requirements. To address the opioid crisis, the federal government plans to introduce even stricter controlled substance reporting requirements. A great pharmacy law attorney can help their highly specialized clients – pharmacists, pharmacies, wholesalers and manufacturers – understand these ever-changing requirements.

Pharmaceuticals, Biologics, and Dietary Supplements

Pharmacists, pharmacies, wholesalers and manufacturers have a wide range of regulatory concerns that arise once their pharmaceutical products have been introduced into the market. A pharmacy law attorney can help these clients understand regulatory issues involving the marketing and manufacturing of pharmaceuticals, biologics and dietary supplements.

Drug Compounding

Compounded drugs are critical for certain patients, but they are also not without risks. Federal and state rules and regulations regarding human and veterinary drug compounding and office use continue to rapidly change. Pharmacist attorneys stay abreast of the many changes and counsel their clients on how best to adjust their current practices to stay in compliance with the new rules and regulations.