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Pharmacy Compliance Pharmacy Audits Lawyers

July 2, 2020

Since pharmacies handle various types of drugs, they are strictly regulated by the DEA and other state and federal agencies. Because of this, federal authorities are always exercising tremendous oversight over pharmacies to ensure they are in compliance with existing rules and regulations. While most pharmacies go about their day-to-day business with few if any problems regarding compliance, others are not so lucky. As a result, they can find themselves suddenly facing questions from federal investigators as well as being subjected to an audit. When this occurs, anything could ultimately happen that could lead to significant penalties for a pharmacist and staff members. If your pharmacy’s compliance measures are called into question to the extent an audit is conducted, do not hesitate to hire pharmacy compliance pharmacy audits lawyers to protect your rights.

Why Compliance Programs are Important
Though they take tremendous amounts of time to create and even more time to enforce on a daily basis, compliance programs are critical to helping pharmacists and staff members avoid making unintentional mistakes that could result in an audit. Since the rules and regulations surrounding pharmacies are more complex than ever, it is very easy for pharmacists and pharmacy owners to not keep their compliance programs up-to-date. When this happens, mistakes will always be made. If they are serious enough, they will gain the attention of federal investigators who will be eager to conduct an audit. If investigators are calling your compliance program into question, say as little as possible until you have hired pharmacy compliance pharmacy audits lawyers to advise you on how to proceed.

Electronic Prescriptions
Becoming a more popular option for most pharmacies, electronic prescriptions are always under tremendous scrutiny by the DEA. Heavily-regulated, these prescriptions require great attention to detail by pharmacists and staff. Otherwise, unintended mistakes can be made that raises red flags with investigators. Should this happen frequently at your pharmacy, it is likely an audit will be conducted to determine the cause.

Drug Ordering and Inventory Management
If it appears as if a pharmacy is ordering unusually high amounts of certain drugs or if certain drugs appear to be missing from a pharmacy’s inventory, the DEA will become very interested very quickly in why this is occurring. Since pharmacists are responsible for completing numerous documents when ordering drugs and verifying their inventory, any discrepancies in records or lacking the required records will result in an audit by the federal government. Should you be unable to explain what has happened, you could be facing stiff penalties including fines, prison, and possibly the closing of your pharmacy if your actions are deemed to be especially negligent or careless.

Prescription Drug Fraud
Since drug fraud leads to billions of dollars each year being lost to the federal government, the DEA and U.S. Department of Justice are constantly examining practices of various pharmacies to find irregularities. In many cases, an audit may determine certain medications were dispensed using invalid prescriptions, or that pharmacists received illegal kickbacks from physicians with whom they had an under-the-table agreement. Whatever the case may be, those who are found guilty of prescription drug fraud will always face a slew of serious federal charges. If you are facing this type of situation, always contact pharmacy compliance pharmacy audits lawyers to make sure your legal rights are always protected.

Billing Violations
At many pharmacies, the pharmacy itself is not directly responsible for billing Medicare and Medicaid. Often relying on third-party billing administrators, pharmacies often mistakenly believe that the third-party billing service is solely responsible for any mistakes that may be made. However, this is not true. In almost all cases, the pharmacy maintains responsibility for ensuring the federal government does not get billed excessively. Should an audit by federal investigators determine this to be true, civil and criminal penalties can result.

As pharmacies become more and more regulated by state and federal government agencies, the possibility of making mistakes increases. Therefore, so does the chance of being audited and possibly charged with criminal activity. If your compliance program and other actions have been called into question, act immediately by scheduling a consultation with experienced and knowledgeable pharmacy compliance pharmacy audits lawyers whose advice you can trust.

Pharmacy Compliance Pharmacy Checkup Lawyers

Pharmacies are an essential piece of the healthcare system. Not only do they dispense medicine to individuals who need it, but they also help educate the general public about different medications. Pharmacies also handle potentially toxic and dangerous substances daily.

This is why they need to be regulated by federal and state laws. Because of these regulations, pharmacists tend to find themselves deep in audits and investigations into their operational practices.

Much like how individuals benefit from visiting the doctor for regular checkups, pharmacies also benefit from getting evaluated and assessed every now and then. While a pharmacy can’t visit a doctor for its checkup, it should consult with external legal experts to ensure that every component of its legal and business operations run smoothly and compliantly.

Storage of Potentially Hazardous Medications and Other Toxic Substances

Pharmacies usually store dangerous controlled substances, and drugs used for medicinal purposes. The storage of such drugs is generally controlled by the pharmacy’s respective state board and other federal laws.

In light of this, all pharmacies are required to be in full compliance with the right storage protocols or risk getting fined or face other severe consequences. Regulations surrounding the protocols set in place can be subject to change now and then, and every pharmacy needs to be aware of any minor adjustments to implement them effectively.

External defense attorneys can help ensure that your pharmacy is fully compliant with all the federal and state requirements. Additionally, they can advise you on the best move forward in case of any changes and how they should be effectively implemented.

The Disposal of Potential Harmful Medications and Other Controlled Substance

State and federal laws not only require that pharmacies store the drugs properly; they also require them to dispose of them in the right manner. The guidelines usually dictate how best pharmacies can dispose of drugs and other controlled substances. Any pharmacy found to be non-compliant with the set disposal guidelines risks hefty fines.

Billing Practices

A pharmacy ensures that it stays in business through effective billing. The proper reimbursement received from dispensing various medications and prescriptions is the pharmacy’s sustenance. As a pharmacy owner, it is critical to ensure that your pharmacy doesn’t violate any state or federal law in its billing practices.

Most times, when a pharmacy gets audited, it is usually as a result of inaccurate billing. Sometimes, a pharmacy might be unaware of its improper billing. Efficient billing practices not only keep the auditor away, but it also ensures that your pharmacy is profitable and remains in business.

Hiring legal experts with experience in pharmacy billing can help your pharmacy stay legally compliant as well as promote the best practices in terms of revenue generation for your business.

Controlled Substance and Medication Inventory

If your pharmacy deals with the dispensation of controlled substance and medication, there are several laws in place that you must follow every time a controlled substance is given out. A pharmacy needs to ensure that their records of the controlled substances are accurate and up to date. Additionally, a pharmacy needs to be compliant with the reporting requirements.

Operational Procedures

Pharmacies don’t write prescriptions; they dispense medication as prescribed by the patient’s doctor. However, this doesn’t mean that a pharmacist should accept any prescription without knowing where the patient got it from.

Hiring lawyers to handle your pharmacy’s prescription authentication policies not only ensures that your pharmacy is compliant; the lawyers can also recommend adjustments wherever necessary for full efficiency.

Data Privacy

Pharmacies usually store crucial health information regarding their patients. The pharmacy must keep this information private. Every pharmacy is required to ensure that all the internal safeguards are met.

Additionally, all pharmacies are required to make sure that their data storage software is kept up to date to implement the federally stipulated privacy laws. A pharmacy should always ensure that they monitor their internal system to prevent unauthorized access.


If you are new to the pharmaceutical business, it is vital to ensure that your pharmacy is fully compliant with the state and federal guidelines on entity ownership agreements. You can get in touch with a knowledgeable attorney to help you review your entity’s organizational structure. The lawyer can also advise on the relevant changes to increase efficiency.

Get In Touch With Us

Contact NYC Criminal lawyers for your pharmacy’s compliance checkup. Our team of experienced attorneys can help you with your pharmacy’s compliance issues to get you back on track. Give us a call today to get started on your compliance journey.



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