What Are Compliance Requirements for Pharmacies in the U.S.A?

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Compliance is a very important part of how pharmacies are run, and pharmacies must adhere to compliance obligations, which were introduced as federal law to ensure they are followed, lest they must be legally enforced. Ignoring and neglecting compliance requirements can result in your pharmacy being closed, sanctioned, or fined. Compliance requirements regulate virtually every aspect of pharmacies and how they are run. Compliance manages how finances are handled to how drugs are stored and distributed. The compliance regulations around pharmacies can be vast and complex, but notwithstanding this complexity, pharmacies cannot feign confusion and use it as a defense for not following compliance regulations. Oftentimes, the ‘confusion defense’ will result in an auditor issuing the maximum fine allowable by law.

In this article, we will tell what a few of those compliance requirements are so that if you run a pharmacy in the United States, you know exactly where you stand. Compliance should be a priority for your business, particularly if it is a pharmacy. Pharmacies are expected to be run to the highest standards and to keep data safe and secure. By the end of this article, you will know some of the compliance requirements pharmacies are required to meet.

Pharmaceutical Compliance

Pharmaceutical compliance is an extensive subject. Because of how extensive it is, we have compiled a list of compliance requirements you must be aware of for you to begin establishing pharmacy compliance programs. Here are some of those requirements:

DSCSA

DSCSA compliance is a very important compliance requirement. The Drug Supply Chain Security Act (DSCSA) is a federal law that protects against the distribution of phony drugs. Counterfeit drugs are a big problem in the United States. Counterfeit drugs contribute to many deaths, which is why they must be rooted out. DSCSA compliance requirements include; avoiding unlicensed drug manufacturer’s; avoiding transactions with unregistered drug manufacturer’s registration with the U.S. Food and Drug Administration (‘FDA’) is a mandatory requirement for pharmaceutical companies, and notifying the FDA of any suspicious drugs, or drugs suspected of being counterfeit or illegally obtained.

The Ordering of Prescription Drugs

When pharmacies make orders for prescription drugs, they are required to use Form 222 issued by the DEA, which ensures they are ordering legitimate drugs from reliable and trusted sources, rather than ordering drugs from unscrupulous sources who could tamper with or be sending fake drugs over. Pharmacies must hold onto all documents, books, and transactions associated with shipments for prescription medications, and they must record all received shipments.

Inventory

Inventory management is a very important requirement and one that you should do meticulously in order to avoid being investigated by the Drug Enforcement Agency (DEA) and to avoid finding yourself in any unnecessary trouble. Discrepancies and losses of drugs will prompt an investigation by the DEA, so meticulously arrange your inventory management and ensure you have a high-quality inventory tracking system and protocol in place to carefully watch how drugs are handled and stored.

Prescription Fraud

Prescription fraud is a big problem in the United States, especially considering the huge rise in the use of recreational pharmaceutical drug-taking among the younger generations. You must have an effective protocol in place to monitor and identify the use of false prescriptions and drug fraud. Any instance must be reported to the police, and then to the regulatory bodies who monitor these things.

Prescription Compliance

In addition to prescription fraud protocols, you must also introduce electronic prescriptions. Electronic prescriptions are quickly becoming the most popular method of prescription, for they are a great countermeasure to fraud. Pharmacies must use licensed and appropriate software applications, and they must document and write down any electronic prescriptions that take place.

Diversion Control

Pharmacies are required to adhere to strict regulations when it comes to filling out and dispensing medications so that they ensure the correct drugs are dispensed, and the correct quantities. If incorrect quantities are dispensed, the pharmacy can find themselves in a lot of trouble. Pharmacies must introduce appropriate safeguarding measures to prevent prescription drug diversion.

Medical Necessity

Another important part of compliance, relating to billing compliance, involves ensuring the medical necessity of prescriptions issued to patients. If a payor considers a prescription to be non-necessary, they can refuse reimbursement, and potentially pursue the pharmacy for fraud. It is important to mention here, this is not advocating that pharmacies must second-guess the opinion of healthcare providers’, but they must scrutinize the details of a prescription and verify that it is in fact the correct prescription for the patient. If, for example, a patient arrives with a prescription for morphine, yet only has a cold, a red flag would be raised, and the pharmacy would be required to look into this and establish whether or not this is the correct prescription, or if a mistake has occurred.

Policies and Procedures

So that a pharmacy can appropriately and properly implement compliance protocols and regulations, they must adopt written policies and procedures, and introduce them into their business. These procedures and policies should address every single part of compliance and should be designed around the specific pharmacy’s legal obligations.

Auditing

Auditing is a very important part of compliance. It is important that pharmacies’ take the correct steps in order to ensure the effectiveness of their compliance programs. This is so they can decide whether or not they need to take extra steps at any point. The way that they do this is through internal audits, which happen routinely. Pharmacies must also conduct periodic assessments of new risks associated with compliance and must have documented evidence that these audits have taken place. They must also have protocols in place to execute if any compliance violations have occurred.

Training

Pharmacies are required to extensively train their staff to ensure that no mistakes or mishaps occur, and so that they can ensure their technicians and pharmacists are able to properly adhere to compliance regulations. If technicians and pharmacists are not aware of their responsibilities, it can get a pharmacy in serious trouble.

With the help of this page, you now know a few of the requirements pharmacies are required to adhere to. Thank you for reading this article and we hope that it has been beneficial to you and that you enjoyed the read.

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