The FDA pharmaceutical lab safety regulations for repackaging medication are extensive, but set in place to protect patients, and you, from any negative consequences.
Sanitation regulations for repackaging medication cover many aspects of the lab and handling of pharmaceuticals. From the facility to the equipment to the staff, each must follow guidelines set forth by state and federal governmental agencies.
The Federal Drug Administration (FDA) also 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.
Hopefully, manufacturers are providing even more precautions on their own to ensure safety to the patient, which also helps protect you and your practice.
Keep reading to learn more on the sanitation regulations for repackaging medication.
Sanitation of the Facility’s Interior
Any facility that will receive, store, repackage, warehouse and handle medicines must follow specific regulations for repackaging medication. The size of the building must be constructed to be large enough, but not too large, to handle all processes of repackaging.
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.
Each state sets forth their own guidelines on top of federal guidelines. For example, in Pennsylvania and many other states, it is a requirement that the area in which repackaging takes place shall only contain appliances, equipment and supplies that are necessary for the process, and nothing more.
Sanitation of Construction and Grounds
Construction materials are determined by regulations and there is a lengthy list of requirements. Concrete walls, plaster and paint, flooring resistant to chemicals, and suspended ceilings are just a few examples of the requirements. Lighting, ventilation, plumbing, and sanitation regulations for repackaging medication can bring consequences if the regulations are not correctly followed.
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 for repackaging medication.
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.
Sanitation of Employees
One staff member could disrupt an entire process and create violations if they are not on board with understanding the importance of following regulations for repackaging medication.
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.
Sanitation Regulations For Repackaging Medication Materials
There are numerous codes 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.
Blister packs are typically used for whole, solid medicines. They are pre-formed by a machine. Blister packs can hold medicines such as pills, gel caps and suppositories. They work well in a variety of temperatures and are tamper proof and very hard to destroy.
Blister packs protect medicines from interacting with any environmental contamination. Plus, they are quite durable and safe.
Bottle forms are often used for liquid medicines. However, they can also be used for pill or gel forms. Glass bottles are mostly used for holding liquids. The glass provides extra security and protection.
Plastic bottles are most commonly used for pill forms of medicine, and sometimes powders. The reason most plastic bottles have an orange or brown tint is because those protect medicines from sun damage, or ultra violet light getting into the bottle and ruining the pills.
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. Clean rooms help companies remain compliant with Good Manufacturing Practices.
They certify everything from the staff to construction. Clean rooms offer that extra security that gives you the confidence you need to supply your patients with quality medicine.