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Use of Quality Ingredients in Compounding Pharmacies

Mar 14, 2024
Use of Quality Ingredients in Compounding Pharmacies

Compounding pharmacies cater to the individualized needs of a patient while retail pharmacies work on the principles of ‘one-size-fits-all’. Compounding pharmacies are more ‘individual-centric’ wherein medications are prepared by mixing/altering/combining active ingredients or drugs with multiple ingredients according to the requirement of the patient. Thus, compounding pharmacies offer a therapeutic substitute as per the unique requirement of the patient that can’t be resolved with retail medicines. However, compounding pharmacies have often been considered ‘risky’ primarily because of the prevalent practice of using non-FDA-approved drugs!!

So what is meant by non-FDA-approved drugs?

Before delving further into this, let us brush up on some basics and understand ‘what is a drug’ and ‘how the quality of a drug is the primary requisite for the safety of the medication’ consumed by the patient.

What is a drug?

A medicament is basically made up of two primary components-

  1. Drug, also referred to as Active Pharmaceutical Ingredient (API) 
  2. Excipients or Inactive Ingredients 

As the name suggests, the API or drug is the active ingredient in a medicament that acts pharmacologically to treat/prevent/cure/diagnose a disease. The immediate relief a patient experiences after consuming medication is due to the presence of API in it. Thus, API is the main component of the medicament that offers relief to the patient. While the excipients present in a medicament are the pharmacologically inactive ingredients that act as the carrier for the drug to reach the site. Excipients do not possess any pharmacological activity.  

Based on the origin, drugs or APIs can be 

  • Synthetic API- Further, the synthetic API can be classified as an organic synthetic drug or an inorganic synthetic drug. 
  • Natural API- Further, natural API can be categorized as Phytochemical drug (i.e., drugs from plant origin) or Biochemical drug (i.e., drug of biotechnological origin).

However, whatever may be the source of an API, the quality standards for an API need to be strictly followed. API is the central component that provides relief from the disease state; hence its quality, safety and efficacy are the primary prerequisites for safe and effective medicament. Compromising on the quality of the API raises a serious concern for the patient’s health. 

Pricing drugs in a pharmacy

Manufacturing Processes and API Standards

It is important to understand that the quality of the drug is inculcated throughout its manufacturing process by testing and validating it at every stage and step. The environment and the manufacturing facility also need to be completely clean and validated to ensure there is no contamination in the drug. A substandard API introduces a higher risk of batch-to-batch variations in the potency of the drug and final medicament. A substandard API may possess lower or higher potency and may also increase the chances of contamination in the final product.

This has been observed and documented in the annual survey by the Missouri Board of Pharmacy carried out during 2005-2009 on medicaments from compounding pharmacies. The survey reported that the potency of medications was found to range between 0-450%. While, in 2007, the Ohio State Board of Pharmacy reported that the potency of the medications was found to be between 27-87% and 1380 medications were found to have fungal contamination.1 Similar findings were reported by the Texas State Board of Pharmacy, 2008-2010, 23% of medications fail in overall potency.2

Additionally, these surveys coincide with the rise in reports of adverse events with the usage of compounded medications, indicating the risk associated with the usage of substandard APIs. Since 1990, the Food and Drug Administration (FDA) has reported more than 200 adverse events after the usage of 71 compounded medications. The Center for Disease Control and Prevention (CDC) has even reported mortality due to cardiac arrest on the usage of compounded medication of intravenous colchicine with altered potency.1,2 Thus, usage of quality assured drugs/API as well as excipients in the compounded medication become pertinent to ensure safe and effective medication. 

Pills and injections for ED.

GMP Compliance and FDA Approval in Drug Manufacturing and Compounding

FDA enforces the manufacturing of drugs in GMP-approved facilities to ensure that drugs are manufactured in a clean and validated environment without contamination and with consistency. Manufacturing drugs as per FDA regulations also ensures negligible variations in the batch to batch. Although compounding pharmacies are not under any regulatory binding to use FDA-approved drugs; however the usage of FDA-approved drugs by compounding pharmacies will definitely ensure consistent quality, safety and efficacy of the medicament. 

Principally, for the overall safe and efficacious product, compounding pharmacies should use pure pharmaceutical grade API as well as excipients. Compliance with quality standards laid down by regulatory agencies ensures the quality and safety of the ingredients. According to different quality standards, API as well as excipients used in compounding pharmacy can be categorized as:

  • Pharmaceutical grade ingredients- This is referred to as a substance that is undiluted and possesses purity of more than 99% and should conform to the quality standards it claims. 
  • Pharmacopeial ingredients– The pharmaceutical grade ingredients which comply with the quality standards of the FDA or United States Pharmacopeia (USP) are referred to as Pharmacopeial ingredients (Pharmacopeial API or Pharmacopoeia excipients). 
  • GMP grade ingredients- The Good Manufacturing Practices (GMP) grade ingredients are manufactured according to the guidelines laid down in Current Good Manufacturing Practices (cGMP) and are safe, efficacious, pure and traceable. Such ingredients are manufactured in a GMP-approved facility. Here it is important to be clear that pharmaceutical grade ingredients are GMP grade but all GMP grade ingredients may or may not be Pharmaceutical grade. 

FDA enforces pharmaceutical manufacturers to use either of the above ingredients. Though it is not obligatory, compounding pharmacies are expected to use ingredients of either Pharmaceutical grade or Pharmacopeial grade or GMP grade. Usage of such grade of ingredients by a compounding pharmacy may increase the cost of the medicament but it gives an assurance of safe and efficacious product.

Nausea from semaglutide

The Risks of Using Veterinary Drugs in Humans

When we talk about drugs, additional grades of drugs are also available, viz., human grade and veterinary grades. Therapeutically, the same drug or API can be used for the treatment of Humans as well as Animals. However, this also raises a few questions, ‘Whether Veterinary drugs are the same as human drugs?’ And ‘Can veterinary drugs be used for the treatment of humans?’

Well, the drugs are approved for clinical usage after evaluation in respective species, hence a veterinary drug can’t be used for humans. The approval of the drug is species-specific and is issued after clinically testing it in that particular species. There are many veterinary drugs which can be lethal or have serious adverse effects in humans eg., Clenbuterol, used for respiratory disease in horses, has been reported to be misused as an anabolic steroid by athletes and as a weight loss pill.

However, clenbuterol can induce serious hormonal imbalance leading to hormonal issues like gynecomastia. The approval of veterinary drugs is given after carrying out a battery of pharmacological, toxicological and microbiological tests on a specific species. These tests determine the species-specific safety and efficacy of the drug. Also, these evaluation parameters determine the dose and dosage for its usage in a specific species.  Thus, the usage of veterinary drugs should be completely avoided for human consumption. Broadly, veterinary drugs can be categorized as:

  • Therapeutics drugs – These are the drugs that are used for treating or cure of a disease.
  • Nutritional supplements – These are the drugs that are intended to keep animals healthy by increasing their immunity. Nutritional supplements are also used for increasing the animal yield. A lot of animal energy is drained into increasing the animal yield which makes them susceptible to various infections and diseases. Thus, boosting their immune function by supplementing them with nutritional agents is extremely necessary.

Human drugs are also either meant for therapeutic purposes or nutritional supplements. However, human nutritional supplements are different from that of veterinary supplements and cannot be used interchangeably. Though the broad purpose of human supplements is also to improve and maintain human health by acting on the immune system; the target site of nutritional supplements in humans is different from that of animals.

Further, supplements for humans can be categorized as:

  • Dietary supplements or Supplements– Dietary supplements are over-the-counter supplements that are used to replenish the nutrients deficient in the diet. However, such supplements are often not potent and are not well absorbed by the body as well. 
  • Nutraceuticals– Nutraceuticals offer a potent formulation of nutrients which has the potential to be well absorbed in the body. In the majority of the cases, pharmaceutical-grade substances (API as well as excipient) are used in formulating nutraceuticals. The use of pharmaceutical-grade ingredients in nutraceuticals ensures a safe and effective mediation from which the required nutrients can be well absorbed by the body.

Conclusion

In conclusion, the usage of quality ingredients in a medication which includes both API as well as excipient ensures that the active ingredient will be well absorbed from it without exhibiting any undesirable side effects. The usage of quality ingredients also ensures that the quality and safety of the medication are consistently maintained.

Disclaimer
While we strive to always provide accurate, current, and safe advice in all of our articles and guides, it’s important to stress that they are no substitute for medical advice from a doctor or healthcare provider. You should always consult a practicing professional who can diagnose your specific case. The content we’ve included in this guide is merely meant to be informational and does not constitute medical advice.

References

  • Gudeman, J., Jozwiakowski, M., Chollet, J., & Randell, M. (2013). Potential risks of pharmacy compounding. Drugs in R&D, 13(1), 1–8. https://doi.org/10.1007/s40268-013-0005-9.
  • Sasich, L. D., & Sukkari, S. R. (2008). Unknown risks of pharmacy-compounded drugs. The Journal of the American Osteopathic Association, 108(2), 86.

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