Repackaged medicines are pills, liquids, powders or any other type of medicine that has been transported from a packaging facility to a repackaging facility. Once received, the repackaging staff will remove the medicine from its original packaging and sort the medicine into a safer, more quality controlled packaging.
The goal of repackaging is to increase the safety of medications before they are delivered to patients. This allows you to have more confidence in the medicine you prescribe. It also further protects you and your patients from medication errors that could lead to damage to patients and lawsuits for you.
Let’s take a closer look at what it means for the repackaging company to have strict quality control. Then we can look at what you can do to maintain that level of quality control in your practice.
Quality Control Defined
When a company does everything it can to make sure a product or drug is in top quality condition, they are practicing quality control. They put the drug through processes and experiments to make sure errors are non-existent.
Both manufacturers and packagers take extra steps to maintain this quality with each drug, making consistency a reality within a drug class.
Quality control involves all the actions a company takes to make sure medicines are pure, safe and compliant with all laws and regulations.
Quality Control at the Repackaging Facility
Repackaged medications undergo quality control processes that prevent counterfeiting.
Drugs are registered, making it many times harder for counterfeit criminals to manufacture and deal the product.
Both the Drug Enforcement Agency and the Federal Drug Administration have regulations that repackaging companies must follow.
If repackaging companies fail to adhere to the regulations, they are warned, inspected and eventually shut down and prevented from operating. Repackaging companies are expected to provide documentation and visual proof that all regulations are being met.
The containers used at the repackaging company must prove to be better than the original container from the manufacturer.
The new containers must abide by moisture, light, vapors, and sealant regulations.
Repackaging companies are experts in containers and the standards set forth for protecting medicine.
Repackaging of narcotics and other controlled substances has very strict quality control processes. Controlled substances are coded and labeled. Meaning, they are traceable all the way back to the manufacturer.
Repackaging facilities must follow strict guidelines when it comes to keeping their environment clean. Pharmacies are not held to the standards repackaging facilities are required to follow. From room temperature to how often and with what counters are cleaned.
FDA Requirements for Quality Control
The Federal Drug Administration (FDA) sets forth Current Good Manufacturing Practices (cGMPs) that all laboratories must follow to ensure safety when dealing with pharmaceuticals. These are the minimum requirements to pass inspection.
Equipment refers to any instrument used in the manufacturing of a drug product. This can include computers, processors, sorters and anything else in which the drug comes in contact. Every single piece of equipment must be inspected to ensure consumer safety.
The building where any drug product will be held, processed or packaged endures strict scrutiny by the FDA. The size and location of the building are just as important as maintenance and operations. They are broken down for inspection purposes as internal and external environments.
Training is provided to all staff, no matter what their duties. They are trained in how to keep the facility clean, how to properly handle and dispose of contaminated medication, and how to report errors in the manufacturing process.
Trained supervisors are responsible for making sure the rest of the staff follow guidelines. This includes making cleanliness of the facility and the staff a top priority. Staff must learn how to wash hands properly to dealing with their own illnesses such as the flu, learning when to call off sick.
What You Should Do
With both unit-dosing and multiple-dosing packaging, regulations must be met before distributed to you or your patients.
The containers used must be damage free, even from minor damages that consumers may not even notice. Containers must maintain protection from light that can reduce the effectiveness of medicine. It must also protect from temperature damage when stored correctly.
Make sure containers keep the medicine dry, stay sealed, yet also be easy to open by the patient.
Ensure containers have specific labeling information. The label must state accurate drug names, dosage, instructions, and who to contact in case of emergency. The manufacturer information should also be included.
You should place additional information to include your practice contact information, date of dispensing and any other warnings for the client.
Keeping good records is required. Records must include the date of repackaging, prescription name, physician who will be dispensing the medicine, and drug name. The strength of the drug must be listed, as well as the quantity.
The software used in repackaging must constantly be modernized to create the most efficient processes.
All parts of the production process must be set up to offer the fastest times with computerized controls that are developed to count tablets, sort, package, seal and label.
Everything is not about computers, software and equipment. The staff that are present, must abide by strict regulations too.
Personnel must undergo training, environmental safety and what to do in case of accidents or contamination issues. They must know how to keep the room clean with the implementation of steps established to avoid contamination, from changing air filters to monitoring air flow.
Where to Go for Help
Partnering with an in-office dispensing company is best. Trying to maintain quality control on your own can be difficult. And who would you turn to when you have questions or concerns?
Dispensing companies not only ensure you remain compliant, they can also connect you with the best repackaging company. They can also provide you with the most modern software technology and offer tech support around the clock.
They make it easy for you to provide quality controlled repackaged medicine to your patients, without the fear of errors.