What are Manufactured Compound Drugs?

In order to allow physicians to customize medications for individual patients, many pharmacies “compound” drugs into formulations not commercially available. Compounding involves mixing drugs or changing their route of administration. For example, a patient who needs seven prescriptions every day might have those drugs compounded so that he or she only needs to take one pill per day. Pharmacists might also compound a liquid form of a drug for a patient that has difficulty swallowing pills or capsules.

The Food and Drug Administration (FDA) allows compounding only according to a physician’s prescription, and only in cases where compounding is medically necessary and the compounded formulation is not already available. However, some providers of prescription drugs delivered by nebulizer for respiratory diseases have been using the cover of compounding to mass-manufacture substitute formulations of those drugs. Legitimate compounding pharmacies tailor each compound to the individual patient. By contrast, illegitimate compounders manufacture large amounts of these formulations and then entice physicians to write prescriptions for their formulation, which is not actually FDA-approved.

What is Manufactured Compound Drugs Fraud?

Mass compounding becomes illegal when the provider of compounded drugs is in fact acting as a drug manufacturer without going through the process of FDA approval and review for its products. Manufactured compound drugs that are identical or equivalent to commercially available formulations may also be considered illegal activity.

Because claims for payment for unapproved manufactured compound drugs are often submitted to Medicare, Medicaid, TRICARE, and other federally funded healthcare programs, marketing these drugs as if they were legitimate FDA-approved medicines may constitute pharmaceutical fraud under the False Claims Act.

Reporting Manufactured Compound Drugs Fraud

If you have knowledge of potentially illegal mass-manufacturing and marketing of manufactured compound drugs, your knowledge may provide the basis for a qui tam lawsuit against the manufacturer.

Reporting this fraud is a service to the public because it helps the government reclaim money stolen by fraud from Medicare and Medicaid funds, and it protects patients from unknowingly buying and consuming drugs not approved by the FDA.

Therefore, the False Claims Act affords certain whistleblower protections from retaliation by employers, as well as the potential to receive a percentage of the recovered funds as a whistleblower reward.

The qui tam attorneys of Kenney & McCafferty have over fifteen years of experience representing whistleblowers who report fraud against the government and tax evasion. Dedicated almost exclusively to qui tam actions, Kenney & McCafferty is a high-profile, nationwide qui tam law firm that has successfully recovered billions of dollars for the government, resulting in multi-million dollar rewards for their whistleblower clients.

Kenney & McCafferty attorneys will consult with you about your case, without obligation. All communications with Kenney & McCafferty attorneys during these consultation services are confidential and protected by the attorney-client privilege.

If you have knowledge of manufactured compound drugs fraud or false claim against the government, please email us or call 800-533-1015.

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