FDA Inspections

The FDA has always been known to be vigilant with pharmacy inspections, and recent cases have made the agency more aggressive than ever. The aggressive action is slated to continue, especially when it comes to inspections of and enforcement actions for compound pharmacies.

Extra precautions need to be taken by compound pharmacies, drug manufacturers and outsourcing facilities, and one of those precautions is retaining an experience law firm to help with FDA inspections. The attorneys at Norman Spencer Law Group have more than a decade of experience representing healthcare professionals, including pharmacists facing inspections, investigations and disciplinary actions.

Our lawyers can be particularly helpful during FDA inspections for several reasons.

• The FDA has the power to deliver enforcement action, including criminal prosecution through the DOJ
• Many FDA inspections are launched in response to a complaint or report of an adverse event
• FDA inspections often include Board of Pharmacy investigators, which have the power to discipline pharmacists beyond the scope of the FDA

The healthcare attorneys at Norman Spencer Law Group can help establish that your facility is compliant while responding to investigators and addressing any action you may need to take.

The FDA has the authority to inspect any compound pharmacies and manufacturers when it comes to regulations regarding contamination and sanitary conditions. Manufacturing contaminated drugs can result in criminal and other enforcement action.

For other FDA inspections, different standards apply based on how the pharmacy is registered. Those registered as 503B outsourcing facilities have different standards than those that meet the 503A exemption requirement. The FDA typically only inspects 503A facilities if it receives a complaint or has reason to believe the facility does not meet the exemption.

Pharmacies registered as 503B outsourcing facilities are subject to FDA inspection in a risk-based schedule. Compound pharmacies not registered as 503B facilities are exempt from certain regulations, but the exemptions only apply when each compound drug is directly linked to a prescription for a specific individual. If the facility cannot produce the prescription, the exemptions will no longer be in place.

This rule has resulted in discipline and enforcement action on many compound pharmacies that thought they were exempt from specific regulations. Prescriptions can fail the 503A exemption for a number of reasons, with some of the most common including:

Compounding and dispensing:

• Without receipt of a prescription, or a prescription that identifies specific individual
• Before a receipt of a prescription when no recurring orders exist for a specific individual

Compounding:

• Drugs which are commercially available or other commercially available products
• Products that deviate from the drug prescribed
• Drugs the FDA has withdrawn from the market

Any facility registered with the FDA may be inspected, although inspections are limited to reviewing sterile practices, ensuring the 503A exemption is met, and for-cause inspections in response to a complaint. For-cause inspections are typically not announced, although the FDA may alert the pharmacy to ensure records and management are on hand during the inspection.

Either way, having an attorney present is important. Even if the FDA threatens prosecution for delaying an inspection, our legal team can often work with the FDA to delay the inspection until your lawyer has arrived.

The FDA must also have an inspection warrant in order to inspect a facility. Search warrants often indicate the FDA is looking for evidence of criminal activities, as does the presence of law enforcement during the search.

FDA inspections are generally limited to records related to alleged violations, but not records related to research, sales, personnel and financial data. Photographs of the facility are often part of the inspection, as is collecting samples with proper documentation of what’s been collected. Having an attorney from Norman Spencer Law Group on hand helps to ensure the FDA does not exceed the scope of the search or fail to produce proper documentation.

Once the inspection is complete, the FDA investigator will issue a form that provides a list of any deficiencies found. Our attorneys can help at this stage, ensuring the deficiencies are addressed before the FDA takes its final action. Promptly submitting an action plan can reduce the likelihood of discipline or enforcement action.

Some of the most common pharmacy deficiencies include:

• Inadequate sterilization, cleaning, disinfectant or gowning of operators
• Poor air quality and failure to keep air sampling logs
• Improper incubator temperature or failure to keep temperature logs
• Failure to keep adequate prescription records for compound drugs
• Failure to adequately test products for microbial’s or potency

Warning letters are informal advisories designed to bring voluntary compliance with regulations. They may or may not be accompanied by enforcement action.

Injunctions and temporary restraining orders from federal court can be issued for more severe violations, such as those causing health hazards or public health risk.

Additional action that may accompany warning letters, injunctions and temporary restraining orders may include:

• Market withdrawals and recalls
• Suspension of operations
• Seizure of products that violate regulations
• Civil monetary penalties
• License revocation
• Criminal prosecution

The attorneys at Norman Spencer Law Group are not only familiar with the FDA inspection process, but we have successfully defended hundreds of healthcare professionals facing charges and disciplinary actions. We stand by our clients at each stage of the process, protecting their rights and ensuring the most favorable outcome of the case. Contact us for a consultation today.