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Pharmacy Compounding

Solutions Pharmacy Compounding

Although compounding may occur in different settings, it is most commonly done in pharmacies. Compounding in general is a practice where a licensed pharmacist, a licensed physician, or in the case of an outsourcing facility, a person under the direct supervision of a licensed pharmacist, combines, mixes, or alters the ingredients of a drug to create a sterile or non-sterile preparation tailored to the needs of individual patients.

These are usually provided when an FDA-approved drug is not medically suitable for the treatment of a patient. Example of which can be when someone is allergic to a certain dye and needs a medication to be made without it. Another scenario would be of an elderly patient or a child who is unable to swallow a tablet or capsule, hence requiring a medicine in a liquid dosage form.

Compounded drugs serve an important medical need for patients, but at the same time may present certain risks as they do not have the same safety, quality, and efficacy validation as compared to approved drugs.

Drugs compounded in outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements. While, drugs compounded by a licensed pharmacist in a state-licensed pharmacy, or federal facility, or by a physician, in accordance with the conditions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), are exempt from compliance with CGMP requirements; however, these facilities can still be subject to less stringent quality standards set per state.

Regardless of where compounding occurs (e.g., pharmacy, outsourcing facility, physician’s office), these drugs must not be prepared, packed, or held under insanitary conditions. Poor compounding practices can cause serious drug quality problems, such as contamination or dispensing of medications that do not possess the strength, quality, and purity that the drugs are supposed to have; these factors can then lead to serious patient injury and death.

Esco Pharma provides specialist services, equipment packages, and process solutions from our core platform products. Together with its wide range of innovative and turnkey solutions, backed with its four (4) core technologies, Esco Pharma enables various industries such as pharmaceuticals, nutraceuticals, and cosmeceuticals to comply with the internationally accredited GMP, as well as, industrial, environmental, and health and safety standards.


References:

  1. Morrow, T. & Felcone, L. (2004). Defining the difference: What Makes Biologics Unique. Biotechnology Healthcare, 1(4), 24-26, 28-29. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3564302/
  2. U.S. Food and Drug Administration. (2019). Center for Biologics Evaluation and Research (CBER). Retrieved from: https://www.fda.gov/about-fda/fda-organization/center-biologics-evaluation-and-research-cber
  3. U.S. Food and Drug Administration. (2018). What are "Biologics" Questions and Answers. Retrieved from: https://bit.ly/FDAWhatAreBiologics
  4. U.S. Food and Drug Administration. (n.d.). Biological Product Definitions. Retrieved from: https://www.fda.gov/files/drugs/published/Biological-Product-Definitions.pdf
  5. U.S. Food and Drug Administration. (n.d.). CDER World: Biologics Review. Retrieved from: https://www.accessdata.fda.gov/scripts/cderworld/index.cfm?action=newdrugs:main&unit=3&lesson=1&topic=1

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