If you received medication covered in dust, you would be concerned. If you received your medication and were told they were handled by a staff member who has the flu, you would be outraged. If you received the wrong medication, or the wrong dose of medication, you would not stand for it. All these scenarios are risky for you and for your patients. This is why repackaging rules are set into place, to protect you both.
Repackaging of medication comes with even stricter rules for sanitation purposes and for overall safety than normal medicine. The laws can make you feel comfortable and secure that your patients will not be harmed when you prescribe the medications they need to meet their health goals.
Keep reading to learn about some of the repackaging rules that are in place for everyone’s protection. First, let’s understand what it means to repackage a product.
What is 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. For instance, your medicine may arrive at the repackaging company in a single container. They may then be removed from the single container and placed in individual blister packs, separating them into single doses. This is considered repackaging for convenience.
The Federal Drug Administration enforces strict repackaging rules when it comes to repackaging any product. Furthermore, the facility must be licensed and certified as an approved site for repackaging. The FDA sets forth such strict guidelines to maintain safety for consumers and to protect you from any malpractice.
Below are a few of the repackaging rules a repackaging facility must follow to pass FDA inspection.
Container Safety Rules
With both unit-dosing and multiple-dosing packaging, repackaging rules and 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.
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.
Keeping good records is required. Repackaging companies must keep quality records for at least one year after the date of being repackaged.
Repackaging rules state 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.
Additional Repackaging Rules
There are repackaging rules and regulations to cover every step of the process. Other than those listed above, repackagers must also meet strict environmental control clean room regulations. These ensure medications are safe from cross-contamination, dust, dirt and any other particles that could affect the drug.
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 must meet exacting standards that can meet both long-run and short-run production needs. 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 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. 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.
Knowing the many repackaging rules and regulations can offer you confidence in your decision to dispense medicines at the point of care. You can know that your patients are receiving the safest product available to help them obtain better health.