Can a physician prescribe a non-FDA (Food and Drug Administration) regulated medication?

From the Guidelines

Yes, physicians can prescribe medications not regulated by the FDA through a practice called "off-label prescribing" or by using compounded medications. According to the most recent and highest quality study, 1, off-label prescribing involves using FDA-approved medications for non-approved conditions, populations, or dosages, which is legal and common in medical practice. For example, amitriptyline, approved for depression, is often prescribed for chronic pain. Additionally, physicians can prescribe compounded medications, which are custom-made by pharmacists to meet specific patient needs, such as alternative formulations or doses not commercially available. However, it is recommended to use FDA-approved medications whenever possible, and to exercise caution when using compounded products that are not approved by the FDA due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.

Some key points to consider when prescribing medications not regulated by the FDA include:

• The potential risks and benefits of using medications without the same level of safety and efficacy testing as FDA-approved drugs
• The importance of careful patient selection and monitoring when using off-label or compounded medications
• The need to follow all available prescribing information about indications, contraindications, precautions, and warnings
• The importance of complying with all government regulations and protocols for prescription and use of these substances

It is also important to note that insurance coverage for non-FDA regulated medications may be limited, and patients should understand the potential risks of using medications without the same level of safety and efficacy testing as FDA-approved drugs. As stated in 1, the guideline text may include information or recommendations about certain drug uses (“off label”) that are not approved by the Food and Drug Administration (FDA), or about medications or substances not subject to the FDA approval process.

In terms of specific examples, 1 mentions that the guideline text may include information or recommendations about certain drug uses (“off label”) that are not approved by the Food and Drug Administration (FDA), or about medications or substances not subject to the FDA approval process. Similarly, 1 and 1 also discuss the use of off-label medications and the importance of following all available prescribing information.

Overall, while physicians can prescribe medications not regulated by the FDA, it is essential to approach this practice with caution and to carefully consider the potential risks and benefits for each patient.

From the Research

Medication Regulation and Prescription

• The FDA regulates medications, but physicians can prescribe medications for off-label uses, which are not approved by the FDA 2, 3.
• Off-label use varies according to therapeutic class and patient group, and often occurs in vulnerable populations 2.
• Prescribers should inform patients and document consent when prescribing off-label, including an open discussion about known and unknown benefits and risks 2.

Physician Prescribing Authority

• Physicians have substantial deference in prescribing practices, including off-label indications 3.
• However, clinicians are not necessarily free to promote a medication for the same off-label indication they may have just prescribed for a patient 3.
• The regulations pertaining to physician and pharmaceutical manufacturers regarding off-label drug use are complex 3.

Comparison of Prescribing Practices

• The quality of prescribing practices of physicians and nonphysician providers, such as nurse practitioners and physician assistants, has been compared in studies 4.
• The results showed that the quality of care delivered by nonphysicians and physicians was generally comparable 4.
• However, significant shortfalls exist in the quality of ambulatory prescribing across all practitioner types 4.

Unrelated Studies

• Some studies are unrelated to the topic of medication regulation and prescription, such as those focusing on dietary intake and mortality 5 or sepsis and immunosuppression 6.
• These studies do not provide relevant information on the topic of physician prescribing authority or off-label medication use.