According to an NIH study, 11–19% of prescription drugs are never dispensed to the patient. Researchers found that in-office medication dispensing may play a role in improving both adherence and care outcomes. At a minimum, issuing prescription medications on-site, also known as physician dispensing, will improve the care experience for your patients and make getting their orders filled far more convenient.

However, if you intend to offer in-office drug dispensing services, you must obtain the appropriate certifications to dispense medication. Join us as we explore the key licenses to dispense medication so that you can meet regulatory standards and maintain quality.

In Office Dispensing Certifications and Requirments:

Before you can engage in point-of-care medication dispensing, you’ll need to obtain the right licenses. The specific certifications to dispense medications vary by state, which can make the entire licensing process a bit complex. However, this high-level overview will help jumpstart your process.

If you want to dispense controlled substances and other medications in-house, you’ll need the following:

Current State License and DEA Number

Before you start applying for certifications to dispense medications, ensure that you have a current state license and Drug Enforcement Administration (DEA) number. This may sound like an obvious step, as you already have a state license number and probably a DEA number, too.

Still, it’s worth mentioning these licenses to dispense medication for two reasons. First, they give you the right to issue prescriptions that are controlled substances under the Controlled Substances Act (i.e., Schedule II, etc.) Second, federal law is incredibly strict regarding the eligibility to dispense controlled substances. That’s why it’s vital for you to carefully adhere to the relevant regulations.

If you don’t have your DEA number yet, you can apply online by submitting form 224. Once you get approved by the federal government, you’ll be eligible to dispense controlled substances. When submitting your application, you will need to provide some detailed information about yourself and your practice.

Keep in mind, though, that the DEA number does not authorize you to dispense medications to treat certain addictions. You’ll need different licenses to dispense medication for those purposes.

Drug Enforcement Agency Requirements

As a dispensing practitioner, the DEA will hold you accountable for following all federal laws when issuing controlled substances. Obtaining your dispensing license places even greater responsibility on you, your practice, and any physician assistants or nurse practitioners who operate under your purview.

As a prescriptive authority, you are allowed to dispense Schedule II through V controlled substances. When dispensing these medications, you must document and verify the following information for record-keeping purposes:

  • Patient’s name
  • Prescribing entity
  • Expiration date
  • Dosage
  • Medication
  • Number of units

You must follow all federal guidelines regarding the prescription and distribution of controlled substances. Otherwise, you could face criminal and civil repercussions that tarnish your brand image and compromise your practice.

Every few years, you’ll have to renew your DEA certifications to dispense medication. You may also have to meet continuing education requirements to be eligible for renewal of your DEA number.

Meet State Regulations

Physician dispensing laws vary by state, which can make it difficult to obtain licenses to dispense medication. The good news is that each state publishes guidelines that detail the licensure process, as well as what sort of medications you are and are not allowed to dispense.

One common variation involves labeling requirements. You must use standardized prescription labels as approved by your state. Your practice may also need to obtain a pharmacy permit from the board of pharmacy. Additionally, you might have to register with the Department of Health before being allowed to dispense medications at your office.

Before you implement a dispensing program, always thoroughly review state law. Find out what the labeling and dispensing regulations are, as well as any applicable restrictions. Make sure to train your team on these regulations, too. Everyone who may play a role in dispensing medications, including registered nurses and pharmacy technicians, should be up to speed on the latest laws and requirements.

Investing in employee training and education will protect your reputation and your medical license. Conversely, failing to adhere to federal and state laws can expose your practice to significant financial and criminal liability. Under the worst of circumstances, violations could lead to your license being suspended or revoked.

Again, remember that diligence is key. Consult with state governing entities as well as third-party distributors to familiarize yourself with all relevant guidelines. Also, ensure that you only partner with properly licensed entities to source your medications. Failing to do so could result in fines or other violations and expose your patients to harm.

Meet State Pharmacy Board Regulations

Each state has its own unique set of pharmacy regulations. When you implement an in-office dispensing program, your practice effectively becomes a pharmacy. As such, you are subject to your state’s pharmacy rules and guidelines.

Most states will require you to follow some basic rules for professional conduct. For instance, you will need to avoid fraudulent activity and maintain patient confidentiality. Each state requires prescription requests to contain specific information about the medicine and patient. Like the federal government, state regulators are especially strict when it comes to controlled substances.

Some states have implemented dispensing physician registration programs, which are meant to help track the issuance of controlled substances and other high-risk medications. The goal of these programs is to reduce the likelihood of doctor shopping and curb substance abuse.

While it can be tempting to view state pharmacy board regulations as a barrier to better patient care, you should treat these boards as a resource and collaborative partner. Their goal is to standardize dispensing processes for the good of patients. That’s an initiative every healthcare professional can get behind.

Still, navigating the licensure process requires patience, as getting the appropriate certifications can be tedious and even frustrating at times. You can simplify the process by partnering with organizations that are familiar with on-site dispensing regulations. The best entities can serve in an advisory role while simultaneously providing you with tools and technologies designed to simplify compliance and promote patient safety.

Proof of Quality at Manufacturing and Repackaging Facilities

Who you partner with matters, especially when it comes to in-office dispensing strategies. You must verify that your distributors and manufacturers are adhering to the Food and Drug Administration’s (FDA) requirements, such as the Drug Supply Chain Security Act (DSCSA).

The DSCSA sets forth stringent tracing requirements for all members of the pharmaceutical supply chain, including manufacturers, distributors, and repackagers. Your suppliers must be appropriately licensed and adhere to the regulations of the DSCSA. The framework is designed to promote traceability and quality control across all medications entering the United States.

After you’ve verified DSCSA compliance, you need to take a deep dive into each prospective partner’s quality control and safety strategies. What are they doing to preserve the integrity and safety of the mediation they are providing your practice? If you have any apprehensions regarding a supplier’s reliability, don’t partner with them. It’s as simple as that.

Remember, too, that the organizations you partner with will have a direct impact on your brand reputation. They will also affect the overall safety of your patients.

Bottom Line: Certification Requirements

When pursuing licenses to dispense medications, you must be cognizant of both federal and state requirements. At a minimum, you’ll need to ensure your state license number is up-to-date and apply for a DEA number. Taking these steps will allow you to write prescriptions for controlled substances and non-scheduled medications.

Next, you’ll need to obtain relevant licenses from your state’s board of pharmacy and potentially the Department of Health. Obtaining these licenses is only the beginning of your in-office medication dispensing journey, though. You must continue to stay apprised of emerging laws so that you can achieve and maintain an ongoing state of compliance.

From there, you can align yourself with trusted names in the pharmaceutical industry. Choosing the right partners is paramount, both for ensuring patient safety and protecting your brand reputation. Focus on well-known, compliant distributors, suppliers, manufacturers, and repackagers so that you can issue prescriptions with confidence.

Implementing a safe and effective in-office dispensing program requires diligence and a proactive approach. State and federal regulators are continuously looking for ways to bolster the medication supply chain and enhance patient safety. These changes often come in the form of ever-tightening regulations, which can affect your compliance posture.

Seeking guidance from governing organizations and physician dispensing companies will help you obtain the appropriate certifications to dispense medications and do right by your patients. Proficient Rx provides free software that tracks everything. The medication is prepackaged and shipped to offices where it is kept locked until being dispensed to a patient. 

Do you want to learn more about the licenses to dispense medication? If so, contact the team at Proficient Rx, and we’ll chat about your certification needs. We also invite you to explore our free resources, such as How In-Office Dispensing Works so that you can better serve your patients through on-site dispensing.