Compounding FAQ

Posted By: benzer | November 26, 2014

What is compounding?

Pharmaceutical compounding is the melding of art and science to produce custom medications tailored to a patient’s individual needs.

Why compound medications?

Many patients have specific medication requirements that cannot be met by conventional, manufactured products. Some examples of required compounding include:

  • Patients with allergies to dyes and other constituents found in a manufactured product
  • The manufactured dosage form is not suitable to the patient (children may require an oral liquid instead of a tablet)
  • The correct dose of medication may not be commercially available (more or less of the active ingredient is needed)
  • The specific drug is no longer conventionally manufactured

Is compounding safe?

All Benzer Pharmacy locations is licensed and the license is in good standing. Our pharmacists and technicians working in the lab receive additional education and ongoing training in the practice of compounding. Benzer uses state of the art equipment to ensure quality products and has an extensive quality assurance program to confirm our compounds meet the highest standard.

Do compounded medications require FDA approval?

All drug/chemical components used in our compounds are approved by the FDA. However, the FDA does not require the final, compounded product to be approved. The FDA drug approval process can cost millions of dollars and take years to complete. This process is required only for mass-produced medications for use across the nation.

Is compounding expensive?

Many factors go into the price of compounded prescriptions: necessary equipment, ingredients, research, and preparation time all comprise to determine a compound’s product price. Access to commercial quantities of pure ingredients helps offset the cost. Compounded medications may be more, less, or comparable to mass-produced medications depending on individual circumstances. Most insurance companies do pay for compounded medications with a traditional copayment. Benzer Pharmacy can bill these medications on your behalf.

What kind of medications can be compounded?

Most! Compounding is especially ideal for patients who require alternative dosages or means of delivery. If you want to know if one or more of your medications can be compounded, please call or ask one of our pharmacists the next time you’re in the pharmacy.

How do you know the chemicals received are of high quality?

All our ingredient chemicals are FDA approved and come with a certificate of analysis. This certification assures the chemical is the correct potency and purity.

Are your chemicals manufactured in the United States?

No, the majority of ingredient chemicals are produced outside the United States. These ingredient chemicals are manufactured in FDA-regulated facilities. The FDA oversees the regulation and standard of products for consumer use in the United States; facilities that fail the standards can be shut down.

Are these chemicals tested for quality and impurities?

Yes, all chemicals are tested for potency and purity and these results are published in the certificate of analysis.

Are all chemicals tested for microbes and endotoxins?

Tests for microbes and endotoxins are not performed on all chemicals. Ingredient chemicals more likely to harbor microbes, per United States Pharmacopeia (USP) stipulations, are tested as such. Other chemicals that by nature are incapable of harboring microbes do not require testing.

Do I need to worry about my compound containing bacteria, viruses, or fungi?

Benzer Pharmacy adheres to strict policies and procedures set forth by the USP for the compounding of sterile products. At Benzer we conduct in-house and unbiased third party testing of sterile products to ensure they are not contaminated with any microorganisms.

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