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compounding

Overcoming challenges in medication accessibility and providing transformative options for personalized patient care, pharmaceutical compounding is an essential solution that bridges the gap in healthcare to meet critical needs.
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What is pharmaceutical compounding?

Defined as the practice of preparing customized medications in accordance to a licensed practitioner’s prescription or essential need, pharmaceutical compounding allows providers the opportunity to:
  • Combine therapeutics
  • Personalize dosing
  • Tailor dosage forms
  • Eliminate unwanted ingredients
  • Provide solutions to product unavailability
  • Enhance patient adherence
pharmacist compounding

Discover the need

Addressing shortages
150 drugs, on average, are reported as being on shortage each year in the United States1. Pharmaceutical compounding acts as a critical safety net that allows providers to fill medication needs during product unavailability, like shortages. Discover how Medisca formulas and products are saving patient lives.

Providing safe medical solutions

Compounding is a highly regulated and disciplined practice that pioneered the practice of pharmacy and maintains an essential role in society today.
Governed by the Food and Drug Administration (FDA)
Under Federal law, the FDA has authority over pharmacy compounding and has issued policies and guidance documents on when compounding is appropriate. Under its authority and for cause, the FDA typically in conjunction with the respective states, inspects compounding pharmacy facilities (503A) to ensure compliance with standards of practice as referenced in the USP, and, in the case of outsourcing facilities (503B) as referenced with Current Good Manufacturing Practice.
Regulated by the State Boards of Pharmacy
In the various states, the state's Board of Pharmacy is the primary regulator of pharmacies, including traditional (503A) compounding pharmacies. Each State Board of Pharmacy has written legislations that govern and legally hold compounding pharmacies accountable for all their operations, including compounding itself.
Standardized by the United States Pharmacopeia (USP)
State Boards of Pharmacy typically adopt in full, in part, or adapted versions of the USP General Chapters that detail standards of practice. For compounding practices, the most noteworthy USP standards of practice are General Chapters USP <795> (Non-Sterile Compounding), USP <797> (Sterile Compounding), and USP <800>(Hazardous Drug Compounding).

What to look for in a
compounding pharmacy

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Commitment to quality

From the supply source to the final compounded preparation, quality is a commitment at every level of the process. When selecting a compounding pharmacy, it is important to ensure that all active pharmaceutical ingredients (APIs) are sourced from FDA-registered and inspected establishments that adhere to Good Manufacturing Practices and have robust vendor qualification, testing, and documentation programs.

Discover Medisca quality
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Investment in education

It is important to ensure that all compounding pharmacy personnel are engaged in continuing education opportunities that allow them to stay up-to-date on recent advances in compounding practices and personalized medicine. This should include regular hands-on laboratory training for compounding personnel and clinical training for pharmacists involved in the clinical decision making process.

Discover LP3 Network education
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Standardized operations

Each compounding practice is required to implement and operate by a set of Standard Operation Procedures (SOPs) that identifies how they ensure compliance with standards of practice, notably compliance with USP <795>, <797>, and <800>. Regular documentation is required and proof of SOP implementations is something patients and providers should inquire about, and something that Medisca supports pharmacies with.

Learn about Medisca SOPs
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Drive for innovation

Technology is moving fast and it is important that new technology be continually evaluated and implemented into practice. Compounding was once and still can be a very manual process (mortar and pestle). Today there exists various technology and equipment, such as the Medisca MAZ® Mixer, that allows for standardization in the process, reproducibility, homogenous mixing, better quality, and more efficient and simplified processes.

Discover the MAZ Mixer

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  1. American Society of Health-System Pharmacists. (2017). Drug shortages statistics. ASHP. Retrieved from: https://www.ashp.org/Drug-Shortages/Shortage-Resources/Drug-Shortages-Statistics
  2. McPherson, T.B. et al. (2013). Patient-centered care as a value-added service by compounding pharmacies. International Journal of Pharmaceutical Compounding, Vol 17. P 339-343.

  3. Azer, S.A., Kanugula, K., & Kshirsagar, R.K. (2023). Dysphagia NIH – National Library of Medicine. StatPearls.

  4. Beubler, E., et al. (2006). The white paper on opioids and pain: A pan-European challenge: The European white paper on the use of opioids in chronic pain management. J Pain Palliative Care Pharmacother., 20, 79-87.

  5. Branvold, A & Carvalho, M. (2014). Pain management therapy: the benefits of compounded transdermal pain medication. J Gen Practice. 2:6.

  6. Vowles KE, McEntee ML, Julnes PS, Frohe T, Ney JP, & van der Goes DN (2015). Rates of opioid misuse, abuse, and addiction in chronic pain: a systematic review and data synthesis. Pain, 156, 569–576.
  7. Simon, JA. (2014). What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? Menopause. 21(7):769–783.
  8. Biondi, B & Wartofsky, L. (2012). Combination treatment with T4 and T3: toward personalized replacement therapy in hypothyroidism? J Clin Endocrinol Metab. 97:2256–2271. 
  9. Bieber, T. (2013). Advances in the management of atopic dermatitis. Future Science Group.
  10. Koyama, G., Liu, J., Scaffidi, A., Khazraee, M., & Epstein, B. (2015). Novel Approaches to Topical Psoriasis Therapy. International journal of pharmaceutical compounding, 19(5), 357–365.

  11. Hay R.J., et al. (2014). The global burden of skin disease in 2010: An analysis of the prevalence and impact of skin conditions. Journal of iIvestigative Dermatology. 134(6): 1527-1534