Physician dispensing allows healthcare providers to prescribe and dispense medications directly to patients within their offices. This practice has become increasingly popular in many states, including California, due to its many benefits for both the patient and the provider. Physician dispensing in California is governed by specific regulations and requirements that healthcare providers must follow to ensure patient safety and compliance with the law. Continue reading to learn more about the rules and regulations regarding physician dispensing in California.

In general, physicians within the state of California are allowed to dispense medications with the required licenses and approvals. In California, prescribers are defined as an individual who holds a certificate or license to practice as a physician and surgeon, optometrist, naturopathic doctor, dentist, veterinarian, podiatrist, nurse practitioner, or nurse-midwife, and who is also registered with the relevant California board, such as the California Medical Board. Certified nurse-midwives, nurse practitioners, physician assistants, and naturopathic doctors, operating under specific protocols or procedures, are also allowed to provide a patient of the supervising physician with a properly labeled, prepackaged prescription drug prepared by a physician, manufacturer, or pharmacist.

Furthermore, according to California Business and Professions Code - BPC § 4170, Article 12 drugs must be dispensed directly to the prescriber's own patient and must be necessary for treating the patient's specific condition. Prescribers must also adhere to pharmaceutical standards for labeling, record-keeping, and packaging, including the use of childproof containers. Before dispensing, California prescribers are required to offer the patient a written prescription that can be filled either by the prescriber or any pharmacy. Additionally, they must provide a written disclosure informing the patient of their option to obtain the prescription from a pharmacy of their choice. Dispensing records must also be retained for a minimum of three years (BPC § 4190, Article 14)

At the federal level, the American Medical Association (AMA) supports physicians' right to dispense drugs and devices in alignment with ethical standards, and many states follow these guidelines. However, state-specific requirements vary. Controlled substances are further regulated by the Drug Enforcement Administration (DEA), necessitating physician registration and adherence to federal rules. Additionally, the Federal Food, Drug, and Cosmetic Act (FDCA) mandates proper labeling and packaging of medications, including those dispensed by physicians.

When thinking about California physician dispensing regulations, it is essential to distinguish between federal and state guidelines. While federal regulations are overarching and provide a broad framework, state regulations, particularly in California, delve into specific requirements set forth by the State Board of Pharmacy.

California dispensers are legally required to report every dispense of a Schedule II, Schedule III, Schedule IV or Schedule V controlled substance to California's Prescription Drug Monitoring Program (CURES) as soon as reasonably possible, but not more than one working day after the date the controlled substance is released to the patient or patient's representative. To make this as simple as possible for our clients, MDScripts automatically includes PDMP reporting for all California dispensers through our PMPReport platform.

Prescription labeling requirements in California mandate that physician dispensing practices comply with the most recent version of the state prescription drug labeling regulations. Below is a current list of the labeling requirements for medications dispensed in the state of California.

• Printed in at least a 12-point sans serif typeface
• Each of the following items, and only these four items, shall be clustered into one area of the label that comprises at least 50 percent of the labels
• Name of the patient
• Name of the drug and strength of the drug. The manufacturer's name may be listed outside of the patient-centered area
• The directions for the use of the drug.
• The condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.

If you are a California physician and are interested in starting a physician dispensing program in your practice or clinic, reach out to our customer support team today, and we will help you get started.

Please note that MDScripts has provided this information for reference purposes only. California state dispensing regulations are subject to frequent changes, so we recommend consulting an attorney or your state medical or pharmacy board for specific questions or to confirm your eligibility to dispense.

Can physicians dispense medications without a pharmacy license in the state of California?

California physicians who wish to dispense medications are not required to have any additional licenses. This activity is allowed under their California state medical license.

Are there any restrictions on the types of medications that can be dispensed by physicians in California?

In California, physicians can dispense most medications commonly prescribed for patient care. However, there are additional requirements for dispensing controlled substances.