There are rules and regulations to cover every step of the repackaging process. These rules ensure medications are safe from cross-contamination, dust, dirt and any other particles that could affect the drug.
It would be horrible if any of your patients received medication that made them sick due to lack of following rules that kept the medication safe from contamination or other damage.
Repackaging companies provide you with the reassurance that your patients can take their medicines as prescribed without encountering safety hazards.
What is Medicine Repackaging?
Medication you order is created by a manufacturer. This manufacturer places the newly created medicine in an original package. This packaging will not be the final packaging. Instead, the medicines are shipped to a repackaging company.
The repackaging company removes the medicine from its original packaging and puts into a safer, more convenient form of storage.
The Federal Drug Administration enforces strict rules when it comes to repackaging any product. Furthermore, the facility must be licensed and certified as an approved site for repackaging.
Below are a few of the rules a repackaging facility must follow to pass FDA inspection.
Clean Rooms
Clean rooms help provide this healthy environment during the manufacturing of pharmaceuticals. Clean rooms focus on the air in the facility where drugs are manufactured. If the air is clean, everything else in the facility will be cleaner.
A clean room is defined as the space used to contain an area that needs to be free of particles that could potentially contaminate a product. They are also used to control temperature and pressure.
Production Equipment and Software
Production equipment must meet standards for both short and long run cycles. The equipment must be at a regulated speed and fully-automated. It must be state-of-the-art and use custom software.
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 is present must abide by strict regulations too.
Personnel Requirements
Personnel must undergo training, environmental safety and what to do in case of accidents or contamination issues. Personnel are required to wear specific protection clothing while in the lab. They have guidelines to follow when dressing and undressing.
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.
Personnel must make sure containers meet regulations also.
Container Safety Rules
With both unit-dosing and multiple-dosing packaging, regulations must be met and approved before they can be 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.
Containers must also keep the medicine dry, must stay sealed, yet also be easy to open by the patient while at the same time hard to open for children. After all these are in place, the containers must still pass inspection with extensive documentation available to support its safety.
The labeling on each container must be correct and easy to read.
Labeling Rules
Labeling and relabeling medicines follow good manufacturing processes set forth by the FDA and The World Health Organization.
The new container must contain 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.
The physician will place additional information to include your practice contact information, date of dispensing and any other warnings for the client.
Record Keeping Regulations
Keeping good records is required. Repackaging companies must keep quality records for at least one year after the date of being repackaged.
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. These steps must be verified and signed by an authority figure in the repackaging company.
Regulations are now including the serialization of medicines to make them easily traceable, especially when repackaging controlled substances.
Quality Control Safety Processes
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 can prevent counterfeiting of drugs. With online sales of counterfeit medicines rising, this is an important safety measure. Prevention of counterfeit drugs can literally save your patients’ lives.
When your patients are safe, your practice is more secure. You do not have to fear liability issues. Good repackaging companies will be excited to tell you all the safety tests they have passed. They will want you to know they strive for perfection in every area, from sorting to labeling to shipping.
In conclusion, repackaged medications are the safest way to provide patients with quality prescriptions. One of the most important steps is to pick a repackaging company that meets your needs, follows all rules and regulations strictly, and can prove themselves to be the best.
Picking the right repackaging company is the step you can take to make sure your patients receive the safest, most effective product.
To choose the best, make sure they meet your budget, your timelines, and your quality. Make sure they are accessible and available to you when you need them. Don’t go with the lowest costing facility. This may mean they are not financially sound.
You want a repackaging company that does not have money problems and more likely to take short cuts to save costs.
Check references of the company and read their reviews. A good company will eagerly provide you with contact information for references. Make the calls. Receiving feedback from other customers is one of the best tactics to help you make a final decision.