Are Compounded Medications Safe? 

Are Compounded Medications Safe? 

Many of us might have heard of a compounding pharmacy and compounded medications. How our bodies react to medicines is different. For instance, your body may positively react to some medication or stimuli, while some other person can have a strong negative reaction to the same medication. This is why compounding pharmacies started to compound medications. There are specially trained pharmacists in these pharmacies who create unique medications specially tailored for the individual wants of the patient and his or her situation. 

 

By compounding, pharmacies started to make custom blend prescription medications beneficial to the user, without any negative side effects which could result from having unnecessary medications. It is at the forefront of the compounding medication industry to ensure the safety and quality of compounded medicines. Therefore, pharmacists and compounding pharmacies must ensure the security and standard of compounded medications. 

 

Distinct Safety Risk Of Compounded Medications 

FDA-approved commercially available medications have two important patient safeguards, which do not usually apply to compounded medications. The drugs must be tested for efficacy and safety and should pass through an approval process before they can be commercially sold in the market. In addition, they should be made under strict federal quality standards. 

 

When compared to the FDA-approved medications, compounded medicines pose more risk. This is because these medications have not been tested for efficacy and safety, nor have they passed any approval process. Above all, most compounded medications come from facilities that do not follow the same quality standards as commercial manufacturers of medications under the oversight of the FDA. 

 

Who Can Compound Medications? 

Usually, businesses producing commercially available medications should get approval from the FDA and should stick to the federal quality and labeling requirements for manufactured medications. Compounders creating personalized medications that are not accepted by the FDA are excused from some laws. The Drug Quality And Security act amended the Federal Food, Drug, And Cosmetic Act to add two types of medications that can be created without the FDA approval processes. These are:

  • Patient-specific compounded medications are created by traditional compounders. Conventional compounders include pharmacists and physicians who make medicines for administering to their patients. 
  • Stock supplies of compounding medications made by outsourcing facilities. Many outsourcing facilities make bulk supplies of compounded medications for doctor offices, hospitals, etc. 

 

If a compounder does not have FDA approval for their compounded product and does not fall into one of the above categories, the compounder is violating federal law by selling the medication.