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:
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.
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.
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.
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.
The Drug Supply Chain Security Act (DSCSA) is enforced by the FDA. FDA regulations cover:
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.
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.
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.
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.
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:
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.
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.
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.
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.
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.
Pharmacies, compound pharmacies, outsourcing facilities, and other pharmaceutical-related businesses are subject to several other regulatory compliance laws. This includes:
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.
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.
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.
Fields marked with an * are required