COMPOUNDING PHARMACY: Disadvantages

By Dr. David Edward Marcinko MBA MEd

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⚠️ Cons of Compounding Pharmacies

1. Quality and Safety Concerns

  • Medications are not FDA-approved, meaning they don’t go through the same rigorous testing as commercial drugs.
  • Risk of contamination or incorrect formulation if strict standards aren’t followed.
  • Potency can vary between batches, leading to inconsistent therapeutic effects.

2. Limited Regulation

  • Oversight is less stringent compared to mass-produced pharmaceuticals.
  • Standards may differ depending on the state or the specific pharmacy.
  • Patients may not always know whether their compounding pharmacy meets high-quality benchmarks.

3. Insurance and Cost Issues

  • Compounded medications are often not covered by insurance.
  • They can be more expensive due to customization and small-scale production.

4. Availability and Accessibility

  • Not all pharmacies offer compounding services.
  • Patients may need to travel farther or wait longer to receive their medication.

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5. Evidence and Efficacy

  • Limited clinical trials or scientific evidence supporting compounded formulations.
  • Effectiveness may rely heavily on anecdotal reports rather than standardized studies.

6. Risk of Errors

  • Human error in measuring, mixing, or labeling can lead to incorrect dosages.
  • Lack of standardized packaging may increase confusion for patients.

👉 In short: while compounding pharmacies can provide personalized solutions, the downsides include less regulation, higher costs, safety risks, and limited evidence of efficacy compared to FDA-approved medications.

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EDUCATION: Books

SPEAKING: Dr. Marcinko will be speaking and lecturing, signing and opining, teaching and preaching, storming and performing at many locations throughout the USA this year! His tour of witty and serious pontifications may be scheduled on a planned or ad-hoc basis; for public or private meetings and gatherings; formally, informally, or over lunch or dinner. All medical societies, financial advisory firms or Broker-Dealers are encouraged to submit an RFP for speaking engagements: CONTACT: Ann Miller RN MHA at MarcinkoAdvisors@outlook.com -OR- http://www.MarcinkoAssociates.com

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The COMPOUNDING PHARMACY?

By Staff Reporters

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DEFINITION:

What is compounding in a pharmacy?

Drug compounding is often regarded as the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual patient. Compounding includes the combining of two or more drugs. Compounded drugs are not FDA-approved.

CITE: https://www.r2library.com/Resource/Title/082610254

What is the difference between a regular pharmacy and a compounding pharmacy?

Both types of pharmacies prepare medications prescribed for a patient by a doctor. The main difference is that a regular pharmacy provides commercial medications in standardized dosages, while a compounding pharmacy can customize medication based on a patient’s specific needs.

Are compounded drugs FDA approved?

Compounded drugs are not FDA approved. And what this means is FDA does not verify the safety effectiveness or quality of compounded drugs before they’re marketed.

FDA: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers

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https://www.amazon.com/Dictionary-Health-Insurance-Managed-Care/dp/0826149944/ref=sr_1_4?ie=UTF8&s=books&qid=1275315485&sr=1-4

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PODCAST: “Cash Pay” Pharmacy

Owner of Independent Pharmacy

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EDITOR’S NOTE: We’ve written, posted and opined on concierge and retail medicine; cash based care and direct primary care medicine, and related machinations before on this ME-P. Now, Shawn Needham and his wife, Janet, discuss starting their own, independent pharmacy in the late ’90s. At first glance, this is a success story for an independent pharmacy but Shawn explains what makes their pharmacy different in a big way.

-Dr. David E. Marcinko MBA CMP® [Edtor-in-Chief]

PODCAST: https://healthcareamericana.com/episode/shawn-needham-cash-pay-pharmacy/

RELATED EXAMPLE: https://www.pharmacytoday.org/action/showPdf?pii=S1042-0991%2821%2900299-1

ASSESSMENT: Your thoughts are appreciated.

THANK YOU

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