What Are the Most Important Requirements for Point-of-Care Dispensing?

Physicians who dispense medication from their practices need to follow state and federal dispensing laws and may need relevant certifications and licenses. The main factors determining what certifications are necessary is the location of the practice. Each state has different laws and requirements for physician dispensing. Another factor is whether the physician is dispensing controlled substances.

Physicians must follow both state and federal laws to dispense controlled substances. The stricter of the two must be followed by all physicians, whether it is their state’s law or the federal law. For example, if the state law is more restrictive than federal law, they must follow the state law and vice versa. Most of the time, federal laws are not as strict as state laws. The state laws are more specific, and they are the most stringent guideline for physicians to follow.

Working with a qualified medication dispensing company can help physicians comply with these often-complicated laws.

State Physician Dispensing Requirements

Most states allow physician dispensing without any registration, some have such strict rules that they essentially prohibit it, and still others require some sort of licensing. If a physician is going to distribute controlled substances, then they will have stricter requirements to fulfill. Generally, additional registration and/or licensing is required.

Each state has a Prescription Drug Monitoring Program (PDMP) and a State Board of Pharmacy that regulate the distribution of medication. All medical practices that dispense medication need to comply with these programs’ rules and requirements. Here is more information about what they are and what their responsibilities generally are.

Prescription Drug Monitoring Program (PDMP)

As of 2017, every state and Washington, DC, has its own Prescription Drug Monitoring Program (PDMP). PDMPs each enforce the relevant state-specific regulations for dispensing medications. The purpose of these programs is to prevent controlled medications, especially opioids, from being overprescribed. Anyone who dispenses controlled substances must report those allotments to their state’s PDMP.

The PDMP has a database for prescribers and dispensers to access to make sure drugs aren’t being prescribed to the same person by multiple doctors. State PDMPs were created as tools to help combat the opioid epidemic. Opioids can be dangerous for the patient they are prescribed to. Overprescribing can also be dangerous because prescribing high dose pills, or prescribing large quantities of pills, increases the opportunity they will be resold to others. Physicians who dispense medication must take their state’s PDMP laws seriously.

State Board of Pharmacy Registration & Licensing

Every state also has its own Board of Pharmacy to enforce its physician dispensing laws. These rules vary state-to-state. Some Boards require physicians to register with them before they can dispense medication. If a physician distributes controlled substances, they will probably need a special license to do so. In some cases, the Board of Pharmacy charges a fee for licensing or registration. Every dispensing physician should contact their State Board of Pharmacy to make sure they are complying with their requirements.

Federal In-office Dispensing Requirements

The United States Drug Enforcement Agency (DEA) and the Food & Drug Administration (FDA) set the most important federal medication dispensing laws. The DEA enforces federal controlled substance laws. The FDA is responsible for making sure food products and medications are safe for public consumption.

DEA Storage Requirements

In order to follow DEA requirements, physicians must keep controlled substances in a secure location. Physicians who intend to dispense controlled substances in their office need to make sure they can follow DEA storage requirements.

According to the DEA, controlled substances must be kept in a locked cabinet of substantial construction. A medical practice needs to consider the local crime rate and the location’s security measures because it is their own responsibility to make sure these medications do not get stolen. For example, a wooden cabinet may or may not be considered “substantial” depending on the circumstances. A dispensing medical practice located in an area with a high crime rate might be required to invest in a reinforced metal safe or other more secure storage option.

FDA Labeling Requirements

The FDA has specific requirements for how medications are labeled. Physicians participating in point-of-care medication dispensing need to follow these rules. Most prescription drug labels need to include the following:

- Common name of the drug

- Drug strength

- Quantity

- Patient name

- Date of issue

- Expiration date

- Instructions

- Prescriber name

- Prescriber’s address and phone number

- Manufacturer and/or repackager identification

Some states have additional labeling requirements. Physicians should check with their State Board of Pharmacy to make sure they follow local laws.

Learn More about the Requirements for Medication Dispensing

The most important step to starting a medication dispensing program is to contact an experienced dispensing services company. The right in-office dispensing services company will know the details of federal and state laws, can help physicians file the correct paperwork, and will make sure practices follow all requirements for dispensing.