Did you know that more than 800 people got seriously ill due to a New England Compounding Center meningitis outbreak in 2012? Due to that unfortunate incident, the federal government passed the Drug Quality and Security Act (DSCSA).
This law was used to address problems in the way that compound medications are distributed and prepared. A compound medication is a personalized medication that is created by mixing multiple drugs.
Do you run a new pharmaceutical or medical company? If so, it’s important that you have a thorough understanding of the 2013 Drug Quality and Security Act. So keep on reading to learn more!
DSCSA Compliance Part 1: The Compounding Quality Act
The point of this section of the DSCSA is to make compound medications safer for consumers. The law created a registration system for pharmaceutical companies that make sterile drugs.
A medical facility can register as an official outsourcing facility if they fit a certain set of criteria. An outsourcing facility is usually a big company that supplies compounds to healthcare organizations like clinics, hospitals, and pharmacies.
In order to become an outsourcing facility, a company must report adverse events to the FDA several times a year. They also need to send reports about all of the compounded medications to the FDA.
A compounding medication company needs to meet product labeling requirements. They need to agree to inspections by the FDA and pay a registration fee to the FDA.
An outsourcing facility is also subject to strict quality standards. They can be penalized for certain actions.
This includes lying about prescriptions for compounded medications. It also applies to making false claims about compounded medications.
It should be noted that the FDA doesn’t approve compounded drugs. This agency won’t verify the effectiveness or safety of these drugs.
Part 2: The Drug Supply Chain Security Act
The Drug Quality and Security Act is a large piece of legislation. It’s meant to prevent contaminated, stolen, and fake drugs from getting into the American market.
The law affects every stakeholder in the medical industry. This includes dispensers, logistics providers, wholesalers, distributors, and manufacturers.
The main point of this law is to have a fully serialized supply chain for the pharmaceutical industry. The main requirements of this law are to have:
- authorized trading partners
- verification of product identifiers
- product tracing
- product serialization
Companies like MedPro Systems® help pharmaceutical facilities meet the requirements of the DSCSA.
The Importance of Knowing About the Drug Quality and Security Act
The Drug Quality and Security Act has altered every facet of the pharmaceutical industry. If you’re considering starting a company within this market then it’s crucial that you fully understand what this law demands. Doing so will make sure that you keep your customers safe and that you stay in line with what the law requires.
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