Non-Sterile Vs. Sterile Compounding Pharmacies

When a commercially-made drug fails to meet the needs of patients, patients may get a prescription for a medication that is compounded. Compounded prescriptions are produced by pharmacists that are specially trained. Many pharmacists specialize in compounding and frequently produce both non-sterile and sterile compounded prescriptions.

At AbbVie, we deal in fill-finish manufacturing. We have successfully advanced and distributed drug products for over 130 years, delivering products to more than 175 countries globally. There is no basis for the question as to whether or not we are excellent at what we do. 

Compounding

Pharmaceutical compounding is described as a practice where a pharmacist – licensed – creates a prescription formulation strictly to meet the unique needs of a patient. This is beneficial for patients for many reasons.

In certain cases, a patient may fail to tolerate the commercially-made drug. This could either be due to intolerance to a particular ingredient in the drug or due to dosage. With compounding, patients can get customized formulas and dosages that omit unwanted, nonessential components.

Non-Sterile Vs. Sterile

In the world of pharmaceutical compounding, what differentiates non-sterile and sterile compounding is more nuanced than many people understand. In pharmaceutical fill-finish, non-sterile medications involve the creation of creams, tablets, solutions, ointments, suspensions, capsules, suppositories, and powders. Sterile compounded medications, on the other hand, are intended to be used as an application to the eye, infusions, or injections.

Is Compounding Safe?

This is a safe practice. Compounding is particularly safe because formulas are produced to meet the needs of specific patients. Due to this, compounded drugs are not envisioned for commercial or mass consumption or production but a specific individual.

Patients who have questions about the meaning of compounding should discuss with a pharmacist or healthcare provider.

Expert Awareness

Pharmacists who produce compounded drugs are licensed to create these medications by applying expertise and knowledge. Non-sterile dosages are routinely produced by these experts. Pharmacies using compounding are subject to rules and regulations laid by both federal and state authorities.  

Safety and Quality

The quality of any medication is crucial to curing an illness successfully and safely. When a compounded drug is prescribed by healthcare providers, it is to ensure that the drug will be most effective and safest for the patient. Pharmacists who produce these drugs are explicitly trained to put these prescriptions together.

Additional Guidelines

In addition to general guidelines by federal and state authorities, compounding pharmacies follow definite standards that are precise to the practice. These standards provide information concerning the purity, strength, and quality of the ingredients used in the compounded supplements or medications. There are many criteria guiding sterile and non-sterile production.

At AbbVie, the nature of your biologic drug notwithstanding, you can count on us when it comes to aseptic fill-finish manufacturing. We will provide reliable, safe, and ready to use products. To learn more about how we can assist you with aseptic fill-finish, contact us now.