What is "Compounding" and why is it in the news? This discussion explains the purpose of compounding pharmacies, their position in the U.S. healthcare market and the recent, national issues associated with it. Review the material and be quickly informed about the topic to engage others! www.healthcaremedicalpharmaceuticaldirectory.com John G. Baresky https://www.linkedin.com/in/johngbaresky #baresky

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“A Conversation About Compounding Pharmacies”
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3. What is “Compounding”?
• Compounding is part of standard pharmacy practice
– Compounding is the preparation / formulation of medication not
available from a manufacturer
– Pharmacists combine different prescription / non-prescription
ingredients to formulate a therapy which better suits a patient’s
needs
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4. Why is compounding necessary?
• Existing product from manufacturers is not available in preferred
dosage / administration form
– Pre-filled syringes, single-dose vials, pre-mixed IV bags are favored
– Dosing strength needs to be less or more
– An additional ingredient needs to be added
• Not all therapies are stable, they are formulated as needed
• Some patients require “non-standard” therapies
– Available product formulations do not suit a patient and / or
needs to be administered differently

5. What types of compounded products are common?
• Medication that is compounded and dispensed via:
– IV bag
– Syringe
– Single-dose vial
• Creams, ointments, solutions
• Suppositories
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6. Don’t all pharmacies compound drugs?
• Most chain/grocery retail pharmacies perform basic compounding
with a very narrow selection of drugs (no IM/IV medications are
prepared)
– Flavoring is added to liquid medications
– Oral therapies are prepared by adding sterile water to the drug
• Some independent retail pharmacies promote themselves as
“compounding pharmacies”
– They actively practice compounding as a way to differentiate
themselves from chain/grocery drugstores
– They typically produce topical creams, ointments and solutions

7. What other pharmacies compound drugs?
• Hospitals, specialty pharmacies and home infusion facilities are
capable of advanced compounding
– This typically involves formulating IM/IV drug therapy
– It requires specific pharmacy training, proper equipment, a sterile
pharmacy workspace and specialized handling / storage of
medications before, during and after preparation
• There are also larger, “institutional” or “closed door” compounding
pharmacies

8. How are larger “institutional” compounding
pharmacies different?
• Their customers may not have the equipment, sterile workspaces or
enough pharmacy staff to produce compounded medication
• They do not provide walk-in, retail pharmacy service
• The product they produce is shipped to various entities including:
– Home Infusion Companies
– Long Term Care Facilities
– Physician Offices / Clinics / Surgical Centers
– Psychiatric Care Facilities
– Prison Infirmaries

9. Who are some of the better known
compounding pharmacies?
• There are many national, regional and locally-based institutional
compounding pharmacies, some of the larger ones are:
– Ameridose
– Cantrell Drug Company
– Central Admixture Pharmacy Service Inc./CAPS
– CuraScript
– Omnicare
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– PharMedium
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– Wedgewood Pharmacy Pharmaceutical
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10. Why are compounding pharmacies in the
news?
• Some government and industry stakeholders think the FDA should
more assertively regulate compounding pharmacies
• There is debate as to whether they should be classified as
pharmacies or manufacturers
• There are significant issues when they do not:
– Closely follow safe, sterile pharmacy practice which impacts
quality and patient care
– Abide by local, state or federal clinical and commerce regulations

11. What is the outlook?
• Compounding is an ongoing part of standard pharmacy practice and
plays an important role in the healthcare industry
• Individualized patient care and a wider array of treatment options
continues to drive demand for compounded medications
• Health and safety are integral to quality patient care; clinician and
regulatory involvement will continue to assess and improve the
performance of compounding pharmacies

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