Physician dispensing in California involves both the prescribing and dispensing of drugs directly in the physician’s office or care facility. Qualified individuals with the appropriate medical license, including doctors, physician assistants, and nurse practitioners, can dispense medications to their own patients in the state of California.
Issuing prescription drugs at your healthcare facility can improve patient outcomes, access to medication, and overall convenience. However, it’s vital to familiarize yourself with relevant California physician dispensing regulations so that you can ensure safety and avoid liability. To do so, check out this guide to California physician dispensing laws and regulations.
Overview of California Physician Dispensing Laws
Navigating the world of physician-dispensed drugs can be challenging. You’ll encounter state laws and federal regulations that govern what medications you can dispense, as well as recordkeeping requirements and other aspects of your specific program. Here are the primary state regulations that you need to be familiar with.
State Regulations for Physician Dispensing
California physician dispensing is governed under code section Article 12, Section 4170 of the state’s Pharmacy Law, which authorizes you to dispense certain drugs to your own patients. You must also meet stringent labeling requirements designed to promote safe use and adherence. Additionally, you must have an active license with the state medical board.
One of the most important provisions addresses who may package the medication. While a nurse practitioner or physician’s assistant may hand the medication to your patient, it must have been prepackaged by you, a pharmacist, or the manufacturer. According to the California Business and Professions Code, registered nurses may also dispense medication on your behalf.
Many providers partner with physician dispensing companies to source pre-packed medications to simplify dispensing compliance. If you use prepackaged drugs in your clinic, any of the above entities can dispense those medications to your patients. However, there are some limitations regarding controlled substances.
Nurse practitioners and physician assistants can dispense controlled substances as part of a standardized procedure in certain settings, including free clinics, community care facilities, and primary doctor’s offices. They cannot dispense these medications at their own discretion.
Registered nurses cannot hand patients controlled substances and other restricted dangerous drugs, including Schedule II and Schedule III drugs, under any circumstances in the outpatient setting. They can administer these drugs in hospitals and critical care settings under the direct supervision of a qualified provider.
Role of the California State Board of Pharmacy
The California State Board of Pharmacy regulates all dispensing doctors and pharmacists within the state. Healthcare providers who wish to act as dispensing physicians must register with this entity and pay a licensing fee.
Make sure to thoroughly explore your state board’s website, including licensing requirements, recordkeeping rules, and definitions. Pay particular attention to definitions of key terms, including formulary and distributor, as these concepts and the underlying frameworks that govern such entities may apply to your practice.
Key Considerations and Requirements
After meeting the basic state-level requirements for in-office dispensing, you must meet other key provisions, including the following:
Prescription Labeling and Patient Counseling
California has some of the most stringent labeling requirements for prescription medications. According to the health and safety code, you must include the following information on the package or bottle of any prescription drugs:
- Patient’s name
- Prescription name and dosage amount
- What the drug was substituted for (e.g., Metformin, generic for Glucophage)
- Manufacturer’s name
- Use instructions
- Expiration date
- RX#
- Prescribing physician’s name
- Office contact information
- Patient contact information
- Quantity
Additionally, the state has strict patient counseling requirements. Under the traditional dispensing model, these instructions are typically provided at the drugstore. However, when you provide in-office dispensing, this responsibility falls on your shoulders. A qualified team member should review usage instructions to enhance adherence and help the patient avoid adverse interactions.
While you can meet some of these requirements by issuing a simple pamphlet, taking the time to address each patient’s individual concerns, especially when starting them on a new medication, can go a long way toward promoting trust and safety.
Controlled Substances and DEA Compliance
The state of California permits physicians to issue certain scheduled drugs to their own patients. However, if you intend to dispense these types of medications to those in your care, you’ll need to register with the Drug Enforcement Administration and obtain a DEA number.
After you’ve obtained your DEA number, you and your team will need to become familiar with DEA and FDA requirements regarding the sourcing and dispensing of controlled substances. Generally speaking, you can only issue a three-day supply of a scheduled drug. However, there are some exceptions, in which case you may be allowed to dispense a seven-day supply.
Also, make sure to stringently adhere to these limitations to avoid compliance issues and fines. Furthermore, it’s important to document all transactions involving controlled substances, including inbound shipments and every prescription you write.
While you can keep certain records manually, adopting cloud-based recordkeeping software offers better security and liability protection. Such technology can also automate key tasks and reduce the likelihood of human error.
Benefits and Challenges of Physician Dispensing in California
Adopting a physician dispensing program can enable you to better serve your patients and effectively meet their needs. However, there are several key challenges associated with storing and dispensing medications in the office.
Impact on Patient Care and Access
In terms of benefits, physician dispensing has a direct impact on patient care. You can get important medications in the hands of your patients faster, which may promote improved outcomes and a faster journey toward better health.
For instance, suppose that one of your patients needs an antibiotic to address a bacterial infection. Under the traditional model, you would have to issue them a prescription and send this information to their preferred pharmacy.
Then, they would have to spend an hour or more driving to the drugstore and waiting for their medication. If they run into any issues, they might not get their antibiotic until hours later or even the following day.
By bringing this entire process under one roof, you promote accessibility and convenience. If there are any questions about insurance reimbursement or other issues, your team can address them on the spot. That way, the patient leaves with their much-needed medication, and your team has successfully improved their treatment outcome.
Regulatory Compliance and Practice Efficiency
Embracing the in-office dispensing model represents a huge leap forward in practice efficiency. Think about all of the hours your team wasted over the last year calling pharmacists, resending prescription requests, and navigating miscommunications with drugstores.
Physician dispensing eliminates all of these headaches. As a result, your staff can focus less on tedious administrative tasks and spend more time doing what really matters: delivering quality care to patients.
Nonetheless, you’ll have to navigate some complex regulatory compliance challenges before you can achieve improved levels of efficiency. This means familiarizing yourself with both state laws and federal regulations. You’ll also have to adopt new workflows and upskill your staff to ensure everyone knows the legal implications of in-office dispensing.
Best Practices for California Physicians
Are you ready to add value to the care journey and better serve your patients through in-office dispensing? If so, here are some best practices to embrace along your journey.
Training and Continuing Education
The success of your new program hinges on the skill and confidence of your team. Therefore, you must invest in high-quality training and continuing education. Start by sharing the “why” behind your plan so you can get everyone on board.
From there, focus on teaching team members role-specific skills that will allow them to effectively support the new program. However, avoid limiting people to a single niche. Instead, it’s important to cross-train so that staff members can step up and perform multiple roles if needed.
Don’t stop there, though. Remember that California physician dispensing laws are continuously evolving. Invest in continuing education to keep everyone up-to-speed on the latest regulatory and compliance requirements.
While dispensing medications in-house can be a great asset for your business and its patients, it also opens you up to new liabilities. Continuing education mitigates these risks.
Integration of Technology and Automation
A well-trained staff is a vital piece of the puzzle, but you’ll also need to empower your team with technology and automation tools if you want your program to thrive. Software like Proficient Rx automates important tracking and recordkeeping processes, reducing the likelihood of human error and maximizing office efficiency.
With Proficient Rx, you can gain optimal visibility into your medication inventory. Our platform assists with inbound order tracking, inventory management, and documenting new prescriptions. We give you the tools needed to make your physician dispensing program a true asset to your practice.
Empower Your Practice With Proficient Rx
Do you want to learn more about how doctor dispensing works? If so, we invite you to explore our growing library of free resources and educational materials. From reporting guidelines to general tips for building your own program, you’ll find it all in our content library.
If you’d like personalized support or have questions about our software, contact us, and we can discuss your practice’s needs.