Compounding Pharmacy Lawyer (503A / 503B)

Pharmacies may manufacture their own drugs and prescriptions for various reasons. Those who do must comply with a myriad of regulations to be allowed to alter or manufacture prescriptions.

An experienced nationwide compounding pharmacies attorney at Innova Health Law can help you get licensed and comply with all of the applicable laws and regulations. We can also assist you with the business law aspects of your company. Attorney Matthew R. Ludowig is deeply experienced in the pharmaceutical industry, and he can partner with your company to help you obtain the best possible legal results.

Innova Health Law is located at 2100 West Loop South Ste 700 Houston, Texas 77027, right near the corner of San Felipe Street and we work with clients throughout the United States. Reach out to a compounding pharmacy attorney at Innova Health Law to learn how we can help you.

What Is a Compounding Pharmacy?

When you go to a traditional pharmacy, they dispense pre-manufactured drugs. There may be reasons why this is not feasible or practical for a specific patient situation. They may not be able to tolerate a specific drug, yet they still need medication for a problem. There could be a shortage of medication from approved sources, requiring a pharmacy to make batches on its own. A compounding pharmacy is one that has the ability and right to create or alter medications for patient needs.

What Is the Difference Between a 503A and 503B Pharmacy?

There are two different types of pharmacies that may have the ability to compound medications:

• A 503A pharmacy can create medications to meet patient-specific requirements. They have a more limited permission to compound medications. Accordingly, they may be more lightly regulated, needing approval from a state board of pharmacy. Each compound that the pharmacy makes must be a response to a specific patient’s prescription need.
• A 503B pharmacy has broader permission to create drugs in bulk. They are a recognized outsourced manufacturing facility. A 503B pharmacy is not limited to merely manufacturing prescriptions in response to a specific patient need. The trade-off is that they are subject to more extensive regulation from the FDA. They must undergo regular inspections from the FDA.

Starting Up a Compounding Pharmacy

There are both business and legal steps that you need to start up a compounding pharmacy. From a business standpoint, you need to do things like secure location, choose the proper form for your business and reach contractual agreements with vendors and possible customers. From a legal standpoint, you need to be aware of all of the requirements that you need to follow to start and operate a compounding pharmacy.

You would need to obtain a number of permits and approvals for your compounding pharmacy business, including:

• A license from the state in which you are operating (regardless of whether you are a 503A or 503B pharmacy)
• Possible approval from the FDA (if you are a 503B Outsourcing Facility)
• A license from the DEA if you are creating prescriptions that involve controlled substances
• Meet the appropriate USP standards for a safe and sterile environment
• Make the necessary enrollments for billing (such as with Medicare and insurance companies)

Litigation and Regulatory Actions Involving Compounding Pharmacies

Compounding pharmacies can face litigation risks on a number of fronts. These can include:

• Enforcement actions from the FDA if they believe that you are not following the rules
• Lawsuits from patients if they claim that the prescription injured them
• Disputes with employees, vendors or other parties that you are doing business with
• Lawsuits that claim that compounding pharmacies misbranded or improperly marketed drugs
• Cases against healthcare providers, who would then turn around and try to blame the compounding pharmacy
• Patent infringement lawsuits, when a drug company alleges that a compounding pharmacy is selling products that are substantially similar to their own protected offerings.

It is essential that you are both aware of the risks, and you are proactive to prevent them from becoming active lawsuits. You need policies and procedures, and the business should stick to them at all times. If you are engaged in a dispute, you need help from an experienced compounding pharmacies attorney, who can defend your business or take legal action on your behalf.

How a Compounding Pharmacies Lawyer Can Help You

A compounding pharmacy attorney can help you in a number of ways. They can:

• Assist you in starting up your company from a business law standpoint
• Ensure that you are aware of potential compliance issues and take steps to manage your risk
• Help with any necessary licensing applications
• Interface with regulators on your behalf if there are any issues
• Defend you in the event of any lawsuits against you
• Work with you on a business plan for your company

Contact a Compounding Pharmacy Lawyer Today

Schedule a free legal strategy session with a nationwide compounding pharmacy attorney at Innova Heath Law. You can speak with a compounding pharmacies lawyer by reaching out to us online or by calling us today at (281) 936-9904.