DEA & FDA Audit Pharmacy Lawyer

DEA & FDA Compliance Attorney for Pharmacies

Compliance with state and federal laws and regulations is important for any industry, but it is especially complex and necessary for pharmacies. Pharmacies must follow regulations put in place for businesses, the healthcare industry, and the prescription drug supply chain. It can be complex to comply with these laws, but it is essential to protect public safety and keep a pharmacy safe from civil, administrative, and criminal penalties.

The Drug Enforcement Administration (DEA) is a federal agency tasked with regulating and managing controlled substances, which includes prescription drugs. It is one of the only regulatory agencies with oversight authority of your business that lacks a health care mission.  The DEA focuses on preventing diversion and their regulations often present barriers to the health and safety of your patients.  That creates a unique challenge for you as a health care provider.  The DEA requires any licensed pharmacy, that stores or dispenses controlled substances, to have policies and procedures for the security and storage of these drugs, corresponding responsibility, and delivery of controlled substances to your patients. These laws are outlined in the Controlled Substances Act (CSA), which the DEA enforces through audits, inspections, investigations, and prosecutions.

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Why You Need a DEA Audit Pharmacy Attorney

DEA audits are a regular part of a pharmacy’s operations, but even a routine audit can become a civil, criminal, or administrative nightmare if any non-compliance with the CSA is discovered. It’s important to prevent these issues before they happen and defend your pharmacy against investigations conducted by the DEA. An attorney is an important partner during this process.

The attorneys with Boesen & Snow have more than 75 years of combined experience in health care and pharmacy law. We focus on this complex area of law to provide pharmacies with exceptional legal services. Our team has backgrounds in pharmacy management, business audits, and other areas of the health care field. We are qualified to help you comply with and defend your rights during a DEA audit or investigation of your pharmacy.

How Boesen & Snow Can Help

Our attorneys can also review your current policies to uncovered any potential liabilities that may lead an audit or  investigation. DEA audits can occur randomly, from a tip received by the DEA, or from other causes. If you are in the midst of an investigation or an audit, it is essential that you get in contact with a qualified DEA audit pharmacy lawyer. Boesen & Snow is based in Arizona but serves clients nationwide. Our attorneys can represent you in the face of auditors, investigators, other DEA agents, and federal prosecutors.

A DEA investigation is very serious, and even a routine audit could become a serious investigation without the proper legal representation. Let Boesen & Snow help your pharmacy comply with DEA laws and keep your business regulated and profitable. It’s important to understand your rights during a DEA audit. That way, you can avoid penalties or actions against pharmacy or  medical provider registrations. We want to help your business succeed while maintaining the necessary protections for the public and for your business.

What Is a DEA Audit?

When the DEA conducts an audit or inspection, they are checking for compliance with the CSA. A DEA audit includes reviewing the licensure and credentials of pharmacists, pharmacy technicians, and other staff. It also includes reviewing the pharmacy’s policies and their implementation to see if they are effective and comply with the law. Policies need to cover areas such as:

• Controlled substances are well-secured during receiving and while they are in the pharmacy
• Prescription drugs are stored and inventoried safely
• Records are well-kept and accurate
• Prescription drugs are ordered and dispensed safely and legally
• There are protections against fraud
• Corresponding Responsibility

The audit may be of the pharmacy and the pharmacists employed there. If the audit determines that there are unlawful actions or that there is a failure of policy, there may be an investigation. The investigation may result in civil penalties like fines, or it may be a more serious matter resulting in criminal prosecution.

What Will Usually Trigger a DEA Audit?

The DEA audits any business or practitioner who is registered with the agency to process, distribute, prescribe, and dispense controlled substances. The DEA conducts regular audits of  pharmacies and its pharmacists about once every 3 to 5 years. This varies based on several factors, such as the prescriptions that pharmacies handle or any treatment programs they offer and the pharmacy’s geographic location. Although audits may  be less frequent in your area, it’s to a pharmacy’s benefit to be prepared for regular as well as unexpected audits. Outside of these regular audits, an audit may be triggered by:

• A tip the DEA received about a practitioner or pharmacy
• Discrepancies between a pharmacy’s prescriptions compared to other pharmacies
• A random inspection
• Unusual activity reported to ARCOS by manufacturers or wholesalers
• Unusual activity reported to the states’ Prescription Drug Monitoring Programs (PMP or PDMP) programs.

Any type of audit can lead to problems for pharmacies if non-compliance or illegal actions are discovered. Any violation of the CSA can result in action against a license and registration. It may even lead to criminal prosecution if the violation is severe.

How Does the DEA Notify a Pharmacy of an Audit?

The DEA is not required to provide a search warrant for its actions to ensure that a pharmacy is compliant with the CSA. This includes audits, inspections, or investigations. In most cases, the DEA provides either a Notice of Inspection or an administrative warrant to inform a pharmacy of an impending audit.  Most of the time the Notice of Inspection is served at the time of an unannounced inspection.

DEA Notice of Inspection

The DEA provides a Notice of Inspection before an audit, also called a DEA Form 82. The form is given to the DEA registrant before the audit or inspection occurs. The notice does not mean that the DEA will immediately begin the audit. The registrant must give informed consent in response to the Notice of Inspection. This is a written statement by the registrant that says:

1. They have been informed of their right to refuse the administrative inspection.
2. They know that anything incriminating discovered during the inspection can be used against them in a criminal case.
3. They voluntarily consent to this.

The audit or inspection can happen once informed consent has been provided. An attorney can help you determine whether it is in your interest to provide informed consent to the DEA for an audit.

However, there are situations where informed consent is not needed for the DEA to perform an audit or inspection of a pharmacy. This includes:

• Pharmacies, clinics, or practices that are applying for their initial registration with the DEA
• Record and document inspection through an administrative subpoena that is under the DEA’s power to subpoena
• When the DEA believes that there is an imminent and present danger to public health or safety and is unable to apply for a warrant

If these do not apply, and the DEA registrant doesn’t provide informed consent, the DEA may instead get an administrative warrant.

DEA Administrative Inspection Warrants

To obtain an administrative search warrant, the DEA has to apply for one with the federal court. An administrative warrant does not require probable cause like a criminal search warrant. The DEA has to explain why it wishes to inspect and the extent of the inspection. These administrative warrants are often granted by a judge. Because it’s common for the DEA to receive an inspection warrant, it may seem unnecessary for a registrant to refuse to provide informed consent. Usually, it provides the registrant time to contact an attorney, or an attorney has advised them to refuse to provide informed consent.

If a pharmacy is presented with an administrative inspection warrant, they are required to comply. If the DEA registrant refuses to comply, they may be arrested and prosecuted. If your pharmacy receives a Notice of Inspection, it’s important to begin working with a pharmacy attorney quickly. Although you may have experienced a DEA audit previously, our attorneys have dealt with them frequently and are well-equipped to protect your rights, your license, and your registration. We can help you understand whether you should provide informed consent or not. Our firm can also ensure that any DEA inspections under an administrative warrant do not go beyond their parameters.

The Scope of DEA Administrative Search Warrants

When the DEA obtains an administrative warrant from the court, they are not allowed to look over every aspect of the pharmacy. It has to provide the court with a list of the documents and information that it wants to inspect and what it wants to seize. Under an administrative warrant, the DEA can interview pharmacy employees and pharmacy owners. It can also look over patient files and records. Your attorney can be sure that these limitations are respected during the inspection.

What Does a DEA Audit or Inspection Look At?

When the DEA conducts an audit, they will be looking for potential violations that fall under DEA authority. They will address certain aspects of the pharmacy, such as:

·   Managing Prescription Drug Inventory

Under the CSA, pharmacies must have a complete inventory of their prescription medications and inventory records for at least the past two years. A pharmacy must readily provide that information to the DEA during an audit or inspection. A pharmacy may face violation penalties if records are not accurate, available, and complete.

·   Packaging, Transfer, and Disposal of Prescription Drugs

There are regulations under the CSA for any transfer of controlled substances. Pharmacies are required to have records that document packaging, transferal, and disposal actions with prescription drugs. It is a violation to fail to follow the CSA guidelines for these actions or fail to document them. A pharmacy that has a third-party disposal of prescription drugs may still be held responsible by the DEA for improper disposal or non-compliance.

·   Preventing Loss and Theft

The DEA requires pharmacies to have security implemented that prevents the loss or theft of controlled substances. Security measures should exist in the pharmacy and when prescription drugs are being transported. Additionally, the pharmacy must have effective methods of reporting and properly informing the DEA of loss or theft. During an audit, the DEA may review both the methods of security and reporting to determine if a pharmacy is complying.

·   Recordkeeping Systems

A pharmacy’s records are incredibly important for a DEA audit. The DEA will need several forms of documentation and records, including those on drug inventories, drug transfer, and drug disposal. In addition, the DEA will review a pharmacy’s internal policy and enforcement of record-keeping. This includes the creation, storing, and maintenance of these records.

·   Monitoring for Prescription Fraud – Corresponding Responsibility

Pharmacies are responsible for preventing prescription drug fraud, just as prescribing physicians are. The DEA will review a pharmacy’s policies to determine that an electronic or physical prescription request is valid. It will also review how the pharmacy addresses potential fraud in either patients or physicians for unnecessary prescriptions. Inadequate policy may result in violations.

·   Ordering Prescription Drugs

A pharmacy has to use the correct form for ordering controlled substances from drug manufacturers, 3rd Party Logistics Providers (3PLs), or wholesalers. This is DEA Form 222, which must be completed correctly along with a pharmacy’s internal record-keeping of ordering and receiving the drug.

In addition to laws enforced by the DEA, a pharmacy must also comply with the Drug Supply Chain Security Act (DSCSA) enforced by the Food and Drug Administration (FDA) and state Boards of Pharmacy. This means that the pharmacy must ensure that the manufacturers and other trading partners (3PLs, wholesalers) that they receive controlled substances from are registered with the appropriate agencies and there is a transaction history that is auditable.

·   Ensuring Proper Dispensing

Under state and federal regulations, a pharmacy has to ensure proper labeling of dispensed medications. There must also be complete and accurate records of drug dispensing. This includes the number of units, the person a unit was dispensed to, and the pharmacist or staff member who dispensed the prescription. A DEA audit may determine that essential information is missing or inaccurate.

·   Preventing Drug Diversion

Pharmacies are responsible for preventing drug diversion when dispensing controlled substances, especially those with a high likelihood of abuse or addiction. The DEA will check for policies and procedures meant to prevent drug diversion.

·   Screening Employees

Pharmacies should run background checks on employees who have access to controlled substances. This includes state and federal checks for criminal convictions, along with determining a history of substance misuse in recent years. The DEA considers this to be a vital aspect of pharmacy security. Pharmacy staff with certain controlled substance criminal convictions are generally prohibited from working in your pharmacy.

What Is One of the Most-Cited Violations During a DEA Audit?

Many of the aspects of a pharmacy that the DEA audit will be reviewing require accurate, complete, and available documentation and recordkeeping. Because of this, violations are frequently found in recordkeeping mistakes and omissions. These errors may be accidents but will likely result in fines for a pharmacy. This is why it’s essential that pharmacies have policies and staff training that ensures that record-keeping regulation is met.

Non-Compliance Reports By the DEA

Following an audit or an inspection, the DEA will determine if there are violations or non-compliance with the CSA. If it finds violations and non-compliance in a pharmacy, it will issue an audit report that explains what issues were found. The DEA may take administrative actions, including revoking the DEA registration of the business or the DEA license of a specific pharmacist or practitioner. The DEA may also refer the case to the Department of Justice (DOJ) for criminal prosecution. If convicted, a DOJ sentence could include a Letter of Admonishment, thousands in fines, or imprisonment.

How Does a DEA Audit Pharmacy Lawyer Help My Pharmacy?

A pharmacy has to comply with several federal and state laws, including the DEA regulations. It can be incredibly complex to follow the legal requirements and statutes of every agency. Additionally, these laws change constantly, making it even more difficult for pharmacies and their owners to effectively run the company.

To comply with and avoid violations during a DEA audit, a pharmacy needs specific and thought-out policies in place. A DEA audit attorney can help you with that. Working with an attorney who has a unique understanding of healthcare and pharmacy law can provide you with the legal guidance you need for all legal and regulatory compliance. This includes DEA and FDA regulations, along with Environmental Protection Agency (EPA) requirements, State Pharmacy Board laws, and other regulatory bodies that apply to pharmacy businesses. This legal guidance and review of your policies limits your business’s risk during DEA audits, PBM audits, and other inspections for compliance. Importantly, it also limits the liability of harm to patients as well as the monetary and reputational damage that it can do to your company.

An attorney can review your pharmacy for liability and weak areas of compliance prior to dealing with a DEA audit. If you have received notice of or a warrant for an audit, an attorney can defend your rights during this process. Your attorney can ensure that you comply with the audit requirements while protecting your rights throughout the entire process of a DEA audit, inspection, or investigation. They can also advocate for your rights during civil or criminal prosecution.

If your pharmacy or a pharmacist employed at your pharmacy is under investigation or prosecution, it can have devastating effects on the reputation and professional life of the employees and the business. The sooner you begin working with a pharmacy lawyer to protect your interests, the more likely it is that they can fight for a positive outcome.

Potential Penalties for Violations of the CSA

If the DEA finds non-compliance during an audit or inspection, or has reason to believe that your pharmacy is non-complying, it could take several actions. These may be against your business, the clinic, or pharmacists. These actions include:

• Assessing civil or administrative monetary fines
• DEA raids
• Criminal charges, prosecution, or imprisonment, sometimes alongside other agencies
• Probation or limiting the scope of a practice
• Asking for the voluntary surrender of a DEA registration or permit
• Suspending a DEA registration until a certain event or for a set amount of time
• Permanently revoking a DEA registration
• Suspending a medical license through the state board

Even if a DEA investigation does not result in criminal charges, a provider could still lose their state license. Even fines, one of the less-serious results of a violation, can result in tens of thousands of dollars in fines. If the violations are numerous, this amount can be much worse. This can be a serious hit to your business.

Understanding a DEA Registration Suspension

A DEA registration is a federal license that allows a practitioner to prescribe controlled substances. The registration for a pharmacist is different from the registration required of a pharmacy business. Individual DEA registrations also require the practitioner to be licensed in the state where they are practicing. DEA registrations for both individuals and businesses require timely renewals.

If a DEA audit leads to the suspension or revocation of a business or individual practitioner’s license, it is very serious. This can alter a practitioner’s career and prevent a pharmacy from remaining in business. Unfortunately, not all DEA revocations or suspensions are the result of intentional harm. Often, a pharmacy or a practitioner has made a mistake or failed to fully train their staff. Although it is the responsibility of a pharmacy or practitioner to uphold their duty of care to the public and to follow regulations, a revocation or suspension can impact the entire livelihood of a person or business.

This is why it’s essential to take audits and inspections very seriously and to take the essential steps to protect your business from liability. An attorney can assist with this and protect your rights. The DEA may send a request to voluntarily surrender a DEA registration. This is rarely recommended. An attorney can help you determine if it’s right for your situation, but it’s usually beneficial to have the DEA present a cause for suspending or revoking a registration. An attorney can then fight against these charges in a hearing.

What Are Grounds for a DEA Suspension?

The DEA is allowed to suspend or revoke a pharmacy’s or a practitioner’s registration only if they can show cause to do so. Grounds for suspending a DEA registration include:

• False information was provided on the DEA registration application.
• There was a felony conviction that involved controlled substances.
• They were excluded from Medicare or Medicaid participation.
• State medical license is suspended or revoked in a minimum of one state.
• An application for a state medical license was denied.
• Behavior is against the public interest.
• They voluntarily surrendered the registration.
• They pose an imminent threat or danger to public health or safety.

An attorney can ensure that you know your rights, help you protect your registration, and work to keep it in good standing with the DEA.

How Must the DEA Show Cause for a Registration Suspension?

For the DEA to show that it has cause to suspend or revoke a pharmacy’s registration, it must create an Order to Show Cause. This document outlines:

• The reasons why the DEA is going to suspend or revoke the pharmacy or pharmacist’s registration
• An order for the DEA registrant to explain why no action should be taken against the registration
• The registrant’s right to request a hearing to respond to the Order to Show Cause

A response or a request for a hearing must be provided within 30 days of revising the Order. Failing to respond or request within that time will waive the registrant’s right to a hearing.

If you receive an Order to Show Cause, you should contact an attorney immediately. They can help you determine if a hearing is within your interests.

A DEA Registration Show Cause Hearing

A show cause hearing is held in front of a federal administrative law judge. Both the DEA and you will present evidence, interview witnesses, and argue their side of things. Entering this hearing without an attorney is not recommended. You will be facing attorneys who have the resources of the DEA, and it is essential that you are prepared.

The DEA holds the burden of proof in a show cause hearing, but this burden of proof is not as high as that in a criminal case. The standard for the burden of proof in this hearing is a preponderance of the evidence. This means that the DEA has to prove that their version of the story is more likely than it is not.

After the judge hears both arguments, they will make a recommendation. This recommendation is not a final order but instead is presented to the DEA administrator. The administrator makes a decision based on the judge’s recommendation and other factors, including if the registrant has:

• Complied with local, state, and federal laws and regulations
• Had prior experience distributing and securing controlled substances
• Taken necessary precautions to prevent loss or diversion of prescription drugs
• Been convicted of controlled substance crimes
• Posed a significant threat to public health

Based on the specifics of your situation, the DEA administrator will determine what action should be taken against your DEA registration. An attorney can help argue your case throughout a hearing and gather essential evidence for the case.

Pharmaceutical FDA Regulatory Attorney

Pharmaceutical and health care regulation is an essential part of a pharmacy or any clinic that prescribes and dispenses controlled substances. State and federal regulations for these businesses can be exceptionally complex, and many agencies oversee pharmacies and similar healthcare providers. One of these agencies is the Food and Drug Administration (FDA).

As a pharmaceutical company, pharmacist, clinic, or practice, you are required to follow the rules set by the FDA. This is important to the safety and health of the public. It is also important to keep your business out of civil or criminal trouble and ensure that you remain licensed and practicing. Regulations for pharmacies are frequently changing and very complex. When you’re managing a business full-time, it can often be difficult to ensure complete compliance with FDA regulations. It can be helpful to work with an FDA regulatory attorney who can review your current policies and determine if they are lacking or have potential liabilities.

At Boesen & Snow, we can review your pharmacy or clinic policy for potential non-compliance with FDA regulations. Our attorneys have been practicing for more than 45 years combined in pharmacy and healthcare law. The team at Boesen & Snow has experience in pharmacy management, other areas of healthcare, business management, and complex legal cases.

We are exceptionally qualified to help you navigate federal healthcare and pharmacy regulations. If you are a pharmaceutical manufacturer, compound pharmacy, or otherwise subject to FDA inspections, you want an attorney who can represent you and your rights during the process. Our attorneys can help you with:

• Creating regulation policies for prescription drugs and medical devices
• Complying with public policy
• Marketing and promoting controlled substances and devices
• FDA inspections and actions

We want to ensure that your pharmacy, manufacturing company, or outsourcing facility is within the FDA’s guidelines to protect it from federal actions. Boesen & Snow is based out of Arizona and provides legal guidance to pharmacies and manufacturers nationwide. We want to help your company grow and profit while limiting your liabilities.

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Who Licenses and Oversees Pharmacies?

The state regulating body for pharmacies is the state’s Board of Pharmacy. They license pharmacists, pharmacy technicians, and interns. Each state has its own Board of Pharmacy. The board also provides permits for wholesalers, manufacturers, third-party suppliers, distributors, medical device manufacturers and distributors, and pharmacies.

There are several federal regulating bodies for pharmacies nationwide. This includes the FDA, the Environmental Protection Agency (EPA), and the Drug Enforcement Administration (DEA). These federal agencies oversee different aspects of pharmaceutical operations and supply chains.

• FDA: Regulates security in drug supply chains and prevents contamination in prescription drugs.
• EPA: Regulates the disposal of hazardous waste, including certain controlled substances.
• DEA: Regulates controlled substances, including how they are monitored, inventoried, and secured. Pharmacies must be registered with the DEA.

Pharmacies are also subject to state and federal regulations that any employer or business must follow. A pharmacy must follow business regulations, healthcare regulations, and controlled substance regulations to remain registered and licensed. Violations and non-compliance with any state or federal regulations can result in civil, administrative, or criminal penalties. Actions against a pharmacy or pharmacist can lead to monetary loss, harm the registration or licensure, and impact a pharmacy’s reputation. This is why an attorney with experience in pharmaceutical and healthcare law is essential to keep your company effective and secure.

What Law Created the FDA?

The origins of the FDA lie with the Pure Food and Drugs Act of 1906, made to protect consumers from mis-marketed and adulterated products. This was led by the Bureau of Chemistry, which was part of the U.S. Department of Agriculture. This Bureau eventually split into non-regulatory and regulatory bodies. The regulatory agency became the Food & Drug Administration. The Pure Food and Drugs Act saw significant changes with the 1938 Federal Food, Drug, and Cosmetic Act (FDCA), which provided further authority and regulating abilities to the FDA.

What Does the FDA Regulate?

The Drug Supply Chain Security Act (DSCSA) is enforced by the FDA. FDA regulations cover:

• Ordering prescription drugs through legitimate and licensed suppliers
• Ensuring uncontaminated and legitimate prescription drugs
• Storage and security of prescription drugs and medical devices on site
• Security and safety of prescription drugs and medical devices during transit along the supply chain
• Marketing and promotion of prescription drugs and medical devices

A pharmacy, manufacturer, or any business that handles prescription drugs has to follow these guidelines. This means having policies and employee training in place to comply with FDA and DSCSA guidelines.

Although individual pharmacies are not often subject to FDA inspection, the FDA can work with the State Board or another federal agency that does have the authority to take action against a pharmacy or pharmacist.

Industries that the FDA regulates include:

• Food and dietary supplements
• Drugs and pharmaceuticals
• Medical devices
• Cosmetics
• Biologics, including vaccines and biosimilars
• Tobacco products
• Medical imaging and other irradiating products
• Veterinary and animal food, drugs, and medical devices

It’s essential to follow the FDA regulations for your industry. This ensures consumer or patient safety. It also protects your company from legal and administrative liability. An attorney can help you review the policies and the implementation of those policies in your pharmaceutical facility.

Why Does a Pharmaceutical Facility Need an FDA Regulatory Attorney?

Healthcare, business, and pharmacy laws are frequently changing. A pharmacy must comply with the current regulations of each of these sectors. When you are running a pharmaceutical manufacturer or other business, you have a lot to take care of. A regulatory attorney can handle compliance policies for you. Without an attorney, you will have to ensure that every aspect and intersection of these compliance laws are met. Otherwise, you will be faced with fines, license suspension, registration revocation, and other civil or administrative penalties.

An attorney can review FDA compliance as well as State Board, EPA, DEA, and other agency compliance requirements. When you work with attorneys who have experience in healthcare and pharmacy law, you can feel confident that your company is more protected against non-compliance. If you are an established business, an attorney can ensure that your policies are up to date and cover all compliance laws. If you are beginning a pharmaceutical company, a regulation attorney can help you create and enact these policies.

How to Ensure Compliance Beyond Written Policy

Written policies are not all that is necessary to ensure compliance. Staff members and employees must be fully trained in compliance procedures, and there must be measures to ensure that those procedures are acted on. Regulation attorneys have experience with creating these policies and helping your business remain compliant.

An FDA regulation attorney is also useful if you are a pharmaceutical company that is subject to FDA inspections. Inspections are conducted to find non-compliance, and an attorney can protect your rights and the rights of your business during the process. If the matter enters litigation, your attorney can advocate for your interests.

The sooner you begin working with an FDA regulation attorney, the more effectively you can limit the liability in your pharmacy or pharmaceutical company.

Steps to Take to Avoid FDA Non-Compliance

There are several actions to take to mitigate risk and liability when creating a pharmacy’s regulatory policy. A regulation attorney and FDA regulatory compliance team can help your business in several ways, including:

1. Compliance Counseling

Compliance with regulation is an ongoing process. As regulation law and/or your business grows and adapts, a regulation attorney can help guide you through these changes with effective legal counsel. This allows you to have ongoing advice for day-to-day needs.

2. Developing and Implementing Complete Compliance Programs

FDA compliance programs can be complicated for pharmaceutical companies. An attorney can create compliance programs and policies that are comprehensive and effective, either based on current policies that a business has or from scratch. The regulatory compliance team will also create training for different employee roles that address each aspect of regulation. These programs can help a business remain compliant with FDA regulations and all other relevant regulatory bodies.

3. Monitoring and Enforcing

Creating a compliance policy is not enough to ensure that regulations are followed. If employees don’t follow regulations, or if the policy becomes outdated, your company would be at severe risk. Although the FDA frequently changes compliance policies, a pharmaceutical company that commits a violation because its policy was outdated does not get any leniency. A regulation attorney can update and revise regulation programs and policies as needed while investigating them for any risk. Your attorney engages in constant research to remain up to date on FDA and other regulatory changes. In maintaining policy, there may also be regular internal audits to ensure that the compliance policies are being followed by employees.

4. Labeling, Marketing, and Promotion

For many pharmaceutical facilities, FDA and Federal Trade Commission (FTC) requirements have to be met during the labeling and advertising of any product, including prescription drugs and medical devices. Claims about a prescription or medical device’s benefits or effectiveness have to be properly substantiated. There are regulations against false advertisement, among other labeling and marketing requirements. An FDA regulation attorney can advise you on these matters.

5. Investigations and Response

An FDA inspection or investigation can have very serious consequences for a pharmaceutical business. A compliance attorney can represent you during these situations, defend your rights, and aim for the ideal outcome of the investigation. An attorney can also help a business with any other agency audits or investigations, as well as third-party claims against a business. A regulatory attorney’s response to these investigations is about protecting your company’s reputation, your license and registration, and your company’s profits.

Non-FDA Compliance Concerns

Pharmacies, compound pharmacies, outsourcing facilities, and other pharmaceutical-related businesses are subject to several other regulatory compliance laws. This includes:

• Billing compliance, including clear records and accurate billing
• Business regulation, including employment law regulation
• Fraud prevention, including billing fraud, prescription fraud, and other healthcare fraud prevention
• FTC compliance for marketing and prevention of deceptive marketing
• Healthcare patient data privacy and security regulations

The attorneys with Boesen & Snow have experience with healthcare and pharmacy regulation for several different regulatory agencies. We understand how these rules and regulations intersect and impact different types of pharmaceutical companies.

Understanding FDA Inspections

The FDA has authority over registered pharmaceutical facilities, including pharmacy manufacturers and 503B Outsourcing Facilities. They can conduct inspections on these pharmaceutical facilities when they are registered with the FDA.

The FDA also has limited authority to inspect compounding pharmacies. Compounding pharmacies may be exempt from FDA authority and compliance if they meet the 503A exemption. However, some compounding pharmacies may believe that they meet this requirement and do not. To meet this exemption, the compound pharmacy must be able to provide copious records for each compounded prescription they produce.

An FDA inspection is usually only announced if it is a regular visit. If the FDA has received a complaint or has another cause for the inspection, there may be no notice of it. In either situation, it’s essential for a pharmaceutical company or pharmacy to have an FDA regulatory attorney present.

Boesen & Snow: Keeping Your Pharmaceutical Facility FDA Regulation Compliant

Regulation compliance is complex and difficult, but it’s incredibly important to the daily function of any pharmaceutical business. When you work with an FDA regulation attorney, you can be confident that your programs and policies can be more effective. It can take time to fully implement and ensure that policies meet the needs of your company, but it is essential to keep your company safe from liability and federal investigation.

At Boesen & Snow, we know what you’re dealing with because we’ve been where you are. We know that the process is complex and overwhelming, and we have the experience to help you prevent risk in your company and comply with state, local, and federal laws. Our attorneys can help you throughout the lifespan of your business. Contact our team to see how we can protect you from administrative action.

Boesen & Snow: Protecting Your Pharmacy and Your Registration

DEA audits and investigations can have significant consequences. The most effective way to prevent these consequences is to ensure your pharmacy’s compliance prior to a DEA audit. The attorneys with Boesen & Snow can review your policies and help you comply with DEA regulations and other state and federal laws. We have the necessary experience to help you limit liabilities.

We can help your pharmacy adapt to any changing laws so that you can provide your patients with protection and keep your business safe. Let us help you keep your pharmacy safe and you in good standing with the DEA throughout an inspection. Contact Boesen & Snow today.