What are Compounded Medications?

But what exactly are these tailor-made treatments, why are they necessary, and what are the important considerations surrounding their use?

At its core, a compounded medication is a prescription drug prepared by a licensed pharmacist (or a licensed doctor, or someone under the supervision of a licensed pharmacist) for a specific patient. This preparation is done in response to a prescription from a licensed healthcare practitioner, such as a physician, dentist, or veterinarian.

The prescription will often detail the individual ingredients and their specific strengths, ensuring the final product is precisely suited to the patient's medical requirements.

Unlike commercially manufactured drugs that are produced in large quantities and are subject to the rigorous Food and Drug Administration (FDA) approval process, compounded medications are made on a per-patient basis when existing options are inadequate or unavailable. This fundamental difference highlights the individualized nature of compounding.

Why Are Compounded Medications Used?

The reasons why a healthcare provider might prescribe a compounded medication are varied and often relate to specific limitations or needs that commercially available drugs cannot address. Some common scenarios include:

Non-existent or Unavailable Products: Sometimes, the exact medication a patient needs doesn't exist in a commercially manufactured form. In other cases, a previously available product might be discontinued or currently facing a drug shortage. Compounding allows pharmacists to create these necessary medications from raw ingredients.

Specialized Strengths or Dosages: Patients may require a very specific strength or dosage of a medication that’s not available commercially. For instance, a young child might need a much lower dose of a medication than what is available in standard adult tablets. A compounding pharmacist can prepare a lower-strength formulation to meet this precise need.

Unique Drug Combinations: In certain medical conditions, a healthcare provider may determine that a patient would benefit from a specific combination of drugs not available in a single commercial product.

For example, a compounded topical cream for treatment-resistant neuropathic pain might include a combination of medications like amitriptyline, baclofen, bupivacaine, clonidine, gabapentin, and ketamine.

Alternative Routes of Administration: Many medications are available in solid oral dosage forms like pills, capsules, or tablets. However, some individuals, such as very young children, those with conditions causing difficulty swallowing (like dementia, Parkinson's disease, and esophageal cancer), or people using a feeding tube, may not be able to safely or easily take these forms.

In such cases, a compounded liquid formulation of the medication can be a more suitable alternative. Furthermore, compounding can offer other forms like creams, ointments, solutions, troches (lozenges), pessaries, suppositories, and even injections (prepared in sterile facilities).

Allergies and Sensitivities: Commercially available medications often contain inactive ingredients such as dyes, preservatives, binding agents, or fillers. Some individuals may have allergies or sensitivities to these non-medicinal components. A compounding pharmacist can create a medication without these specific problematic ingredients, making the treatment tolerable for the patient.

Improved Palatability: Especially for young children, the taste of some medications can be a significant barrier to adherence. Compounding allows pharmacists to add flavoring or sweetening to oral medications, making them more palatable and easier to administer.

Cost Considerations: In some instances, compounded medications might be a more affordable alternative to commercially available preparations, particularly if a patient requires a specific formulation or strength that would otherwise necessitate purchasing a higher-dose or combination product.

Veterinary Medicine: The principles of compounding extend to animal healthcare as well. Veterinarians may prescribe compounded medications for pets when no commercially available medication can meet their unique dosing needs or when a special dosing form is required for easier administration.

For example, a medication for a cat might be compounded into a flavored liquid or a transdermal gel. (Fun fact: One favorite veterinary patient at LLU School of Pharmacy is a French Bulldog named Yoda.)

Hormone Replacement Therapy (HRT): Compounding is frequently used to prepare bioidentical hormones for women going through menopause who desire a more natural treatment approach. These compounded HRT medications can be tailored to individual hormone levels and needs.

How to Obtain and Pay for Compounded Medications

At LookMeds, we understand that compounded medications aren’t a luxury—they’re a lifeline for many patients with unique medical needs. That’s why we’ve simplified the entire process, from prescription to pickup, making access to customized medications easier and more transparent than ever.

Step 1: Choose a Compounding Pharmacy

Not every pharmacy is equipped for pharmaceutical compounding. In fact, only about 7,500 out of 56,000 U.S. community pharmacies offer these specialized compounding services, according to the American Pharmacists Association. That’s where LookMeds stands out.

We’re a fully equipped compounding pharmacy, capable of producing nonsterile compounding forms like oral suspensions and more.

Step 2: Consultation

After completing an assessment, you’ll meet with a LookMeds healthcare professional who will take a deeper look into your medical history.

If your healthcare provider identifies the need for a compounded prescription (either due to a drug shortage, allergy to dyes or preservatives, or the need for a specific dosage form), they’ll write a tailored prescription for you.

Step 3: Begin Treatment

For those seeking a cost-effective solution for weight loss, using compounded semaglutide and compounded tirzepatide (the same active ingredient as Ozempic, Wegovy, and Mounjaro but not FDA-approved) is one of the most affordable options for those without insurance.

LookMeds provides compounded medications at significantly lower prices than brand-name medications. Here’s why LookMeds stands out:

Competitive Pricing: LookMeds offers compounded semaglutide at just $299 per month for daily tablets or weekly injections. These prices make semaglutide accessible to more patients. Tirzepatide injections and tablets only cost $449 at LookMeds.

Personalized Care: Licensed healthcare professionals at LookMeds tailor your prescription to meet your unique health needs, ensuring the right dosage and treatment plan.

Convenient Delivery: We offer the convenience of home delivery within 1-3 days, eliminating the need for pharmacy visits.

No Insurance Required: Unlike traditional insurance plans, LookMeds doesn’t require prior authorization, simplifying the process of obtaining your medication.

Find your new look with LookMeds.

Safety and Regulation: Quality in Compounded Medications

While compounded medications offer numerous benefits, it's essential to acknowledge the regulatory landscape and safety considerations surrounding them.

Unlike commercially manufactured drugs that undergo rigorous FDA review for safety, effectiveness, and quality before being marketed, compounded drugs are not FDA-approved. This means the FDA does not verify their safety, effectiveness, or quality before they are dispensed to patients.

Despite this lack of pre-market approval, compounded medications can be safe when prepared by a reputable compounding pharmacy that adheres to strict quality standards. Many reputable compounding pharmacies, such as LookMeds, follow these strict standards.

However, some pharmacies fail to adhere to these regulations. The absence of FDA oversight does introduce potential risks. These risks can include:

• Contamination with germs or other harmful substances.
• Medications containing too much or too little of an active ingredient, leading to ineffectiveness or toxicity.

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History has shown the potential for harm when quality standards are not followed. In 2012 and 2013, a nationwide outbreak of serious fungal infections was linked to contaminated steroid injections made at a compounding facility, resulting in 753 people becoming ill and 64 deaths. This devastating event highlighted the critical need for robust oversight in the compounding industry.

In response to such incidents, various laws and policies have been implemented to help reduce the risk to consumers. At the federal level, the Drug Quality and Security Act (DQSA), passed in 2013, aimed to preserve access to safe compounded medications while protecting patients from the risks associated with poorly compounded drugs.

The DQSA grants the FDA authority to oversee outsourcing facilities that produce bulk supplies of non-patient-specific drugs, requiring them to adhere to certain protocols to prevent contamination and other dangerous problems.

The DQSA also distinguishes between two categories of compounders: traditional compounders (who make patient-specific medications based on prescriptions under Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA)) and outsourcing facilities (who produce bulk supplies for healthcare providers under Section 503B of the FDCA).

Traditional compounders must receive a prescription for an identified individual patient and can only use permitted ingredients. Outsourcing facilities, on the other hand, must register with the FDA, comply with current good manufacturing practice (CGMP) quality standards (similar to those for drug manufacturers), adhere to specific labeling requirements, and report adverse events.

Because they are subject to these increased federal quality standards, drugs made by outsourcing facilities can be sold to providers without an individual prescription.

The FDCA also defines the specific active drug ingredients (bulk drug substances) that can be used in compounding. Traditional compounders under Section 503A can only use substances that meet certain criteria, such as being recognized in the United States Pharmacopeia (USP), being part of FDA-approved products, or being on an FDA-created list.

Outsourcing facilities under Section 503B can only use ingredients on specific FDA-maintained lists indicating clinical need or drug shortage. Furthermore, the law requires that bulk drug substances used in compounding comply with the relevant USP standards and be manufactured at FDA-registered and inspected establishments. These restrictions help prevent compounding from undermining the safety protections of the drug approval system.

To ensure quality and minimize risks, the USP has developed specific standards for compounding, including USP <797> for sterile compounding (for products like injections and eye drops that need to be sterile) and USP <795> for nonsterile compounding (for other dosage forms like pills, capsules, and creams).

Most states require compounders to follow these USP standards. Even in states without such requirements, the FDA has outlined minimum standards for sanitary drug production.

The fundamental difference in regulatory oversight between compounded and commercially manufactured drugs underscores the importance of working with reputable compounding pharmacies that prioritize quality and safety.

Patients considering compounded medications should discuss the potential risks and benefits with their healthcare provider and ensure the chosen pharmacy adheres to stringent quality standards and follows USP guidelines.

Bottom Line

Compounded medications play a vital role in healthcare by providing personalized treatment options when commercially available drugs fall short. They offer solutions for patients with unique dosage requirements, allergies, difficulties with standard dosage forms, or the need for specific drug combinations. The ability to tailor medications to individual needs highlights the enduring importance of pharmaceutical compounding.

However, it is crucial to remember that compounded medications lack the pre-market approval of the FDA, which introduces inherent risks related to safety, effectiveness, and quality. Therefore, it is paramount to obtain compounded medications through licensed healthcare providers and reputable compounding pharmacies that adhere to established quality standards and regulatory guidelines, such as the USP standards and the provisions of the DQSA.

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