Pharmacy Compliance With These 3 Laws Is Vital

Pharmacies play an essential role in the healthcare industry. These businesses must follow local, state, and federal regulations, so compliance is one of the most important factors to keep up with. If you work in, manage, or own a pharmacy, following these three laws is vital for success.

From the DEA: The Controlled Substance Act (CSA)

The DEA is responsible for regulating the handling, storage, and distribution of controlled substances. They do this through the Controlled Substance Act (CSA). Here are some tips for keeping your operations compliant with the CSA. You can work with an outside company to handle the transfer and disposal of your controlled substances. Unfortunately, theft and losses do happen, no matter how hard you try to be secure. If you experience controlled substance theft, you must notify the local police and the DEA, then fill out a Report of Theft or Loss of Controlled Substances form (Form 106).

As part of security and compliance, your pharmacy must keep accurate records. There should be documentation on every controlled substance that your pharmacy sells, purchases, stores, transports, and disposes of. For the controlled substances you have in your current inventory, there are some guidelines to follow for your record keeping. Maintain records for at least 2 years and make sure they include the initial inventory and newly scheduled inventory. There are other requirements that must be met, including those for filling prescriptions, dispensing medications, and ordering Schedule II controlled substances. It is important to become familiar with all of these and any changes to regulations regarding the rules.

As a side note, there are some steps you can take if your pharmacy receives a prescription for a Schedule II drug that doesn’t have enough information. The DEA suggests that you first make sure everything is compliant by verifying the date, type, strength, and dosage of the prescription and patient name, address, and age. You should also verify the name, address, and registration number of the prescribing physician. Changing or updating the information on a Schedule II prescription depends on various factors. It is vital that your pharmacists use their knowledge of all laws as well as professional judgment when making any changes.

From the FDA: The Drug Supply Chain Security Act (DSCSA)

This law, passed in 2013, focuses on the safety of the drug supply chain in the United States. Pharmacies must focus on providing safe medications to their customers. You must confirm

the licensing and registration of each company you work with. As part of record keeping, you must also keep documentation that traces every step of a drug’s journey. If you do run into suspicious or illegitimate drugs, you must have an established process for working with the authorities.

From the EPA: The Resource Conservation Recovery Act (RCRA)

When pharmaceuticals were found to be in groundwater, surface water, and drinking water, the EPA stepped in with the RCRA. Everyone in the pharmaceutical industry, including pharmacies, should make sure that safety is a main priority. Every step of the process should be monitored, including waste disposal. First, identify all hazardous waste that your pharmacy produces. Next, calculate the total weight of all the waste that is regulated by the RCRA. Then, you will need to notify a local regulating agency or the EPA. Finally, manage, transport, and dispose of the waste following all industry regulations. Your pharmacy may be able to recycle, treat, and dispose of the waste on-site.