Repackaging Medications Standards

Quality Standards for Repackaged Medication

When a company does everything it can to make sure a product or drug is in top quality condition, they have quality standards.  They put the drug through processes and experiments to make sure errors are non-existent.

This is good news for you and your practice. It gives you the confidence you need to reassure your patients that they will not be harmed.

There are multiple quality standards involved to ensure safety for patients. Below are more details on some of these standards.

 

Standards to Prevent Counterfeiting

Counterfeiting mostly happens online, when unethical manufacturers try to pass on illegal forms of medication to consumers. This is a serious crime with severe penalties that will be enforced by the Federal Drug Administration.

Counterfeit drugs usually have the wrong ingredients or the wrong doses of the right ingredients. Both are dangerous for patients.

Repackaged medications undergo quality standards that prevent counterfeiting.

Drugs are registered, making it many times harder for counterfeit criminals to manufacture and deal the product.

 

Standards for Compliance

Both the Drug Enforcement Agency and the Federal Drug Administration have regulations and quality standards 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 World Health Organization sets forth dispensing guidelines that must be followed by the physician and practice staff. Repackaging companies make it easy for doctors to comply with these guidelines, which cover the entire process from writing the prescription to handing medicine to the patient.

 

Standards for Closure

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.

 

Environmental Standards

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.

In addition to these measures, quality standards of repackaging facilities include security tactics including cameras and personnel. Monitoring is controlled with the use of state-of-the-art computerized technology.

Sanitation Standards

Any facility that will receive, store, repackage, warehouse and handle medicines must follow specific regulations.

Every area of the facility must be clean and orderly and free of any type of infestation from rodents or insects. Waste must be properly disposed of according to regulations. It shall never be allowed to collect in any one area.

Facility owners must take into consideration that no eating or drinking takes place where medications are processed or packaged. If a staff member violates these rules, they will be reprimanded.

Proper maintenance of the exterior of the facility are just as important as the interior. The grounds must be cared for so that insects and rodents do not breed and find housing near the facility. Storage of pallets and trash must be done properly to avoid attracting animals of any kind.

Staff need to be trained in how to handle pest control. Meaning, they must consider any chemicals they choose to use to prevent or get rid of pests. These chemicals can interfere with the repackaging process if not used according to regulations.

All repackaging facilities must have an area designated for quarantine of medicines that are damaged, outdated, or contaminated in any way. Their disposal process must also be strictly adhered to so cross-contamination is avoided.

Quarantine of original packaging materials and secondary containers that are no longer useful, as well as any misbranded pharmaceuticals, must be disposed of according to the law.

 

Employee Standards

One staff member could disrupt an entire process and create violations if they are not on board with understanding the importance of following regulations.

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.

 

Material Standards

There are numerous standards to be met when it comes to repackaging materials. From labeling to temperature, package materials must comply or not be used at all.

Companies use the best materials to protect drugs while also keeping the cost reduced. They ensure both primary and secondary packaging meets the standards set forth by governmental agencies.

 

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.

For repackaging medication, temperature, humidity and air pressure are all crucial factors and must be heavily monitored. Using a clean room is essential. If you find the repackaging company you work with is not using a clean room, it is time to switch to one who does.

Your patients can be affected by any type of facility contamination, even it is with the smallest particles. Therefore, repackaging companies take extra steps to follow classification guidelines.

In conclusion, you will find the practices of repackaging companies far outweigh the practices of a pharmacy. Knowing this may entice you to begin in-office dispensing repackaged medication, one of the best ways to ensure patient safety, while also improving long-term health outcomes.

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