The Benefits and Risks of Compounding Pharmacies: When to Choose Customized Medication

Meet Emily.

A 32-year-old woman with epilepsy who takes a commonly prescribed anticonvulsant medication. She has been on medication for the past year and her medications seem to be really helping her symptoms. But this past month she has been experiencing fatigue, headaches, and has a rash on her skin. She knows she has an intolerance to gluten and a mild allergy to certain dyes, particularly Yellow No. 5. But she has not eaten either of those things recently.

What Emily didn’t know is that the local pharmacy, where I was the pharmacist, switched her normal manufacturer to another generic manufacturer whose product contains gluten as a filler and sunset yellow FCF (Yellow No. 6). When Emily picked up the prescription, I noticed the yellow dye allergy and gluten intolerance noted on her pharmacy profile. Since I missed her when she came in, I called Emily later to discuss the potential issue and recommended she use a compounding pharmacy to create a custom, gluten-free and dye-free formulation. The compounding pharmacy worked with Emily’s neurologist to prepare a specially formulated capsule that contained the same active ingredients, but used alternative excipients that she could tolerate. From then on, Emily knew she could trust the medications she was getting.

As an experienced pharmacist, I’ve seen firsthand the importance of finding the right medication to effectively manage various health conditions. While traditional pharmacies offer a wide range of medications, there are situations where a compounding pharmacy may be a better option. In this article, we’ll explore the benefits and risks of compounding pharmacies and when to choose them over local pharmacies.

What is a Compounding Pharmacy?

A compounding pharmacy is a specialized pharmacy that prepares customized medications for individual patients. Unlike traditional pharmacies, which dispense pre-manufactured, commercially available medications, compounding pharmacies create medications from scratch using raw ingredients. This process allows pharmacists to tailor medications to a patient’s specific needs, such as creating custom dosages, flavors, or forms.

Benefits of Compounding Pharmacies

• Customized Medications: Compounding pharmacies can create medications in various forms, such as creams, gels, lozenges, or liquids, which can be more effective for patients who have difficulty swallowing pills or require a specific dosage.
• Allergy-Friendly Options: Compounding pharmacies can prepare medications without certain ingredients, such as dyes, preservatives, or fillers, which can be problematic for patients with allergies or sensitivities.
• Discontinued or Unavailable Medications: Compounding pharmacies can recreate medications that are no longer available or have been discontinued, providing patients with continued access to necessary treatments.
• Hormone Replacement Therapy: Compounding pharmacies can prepare customized hormone replacement therapies, which can be tailored to a patient’s specific needs and health goals.

When to Choose a Compounding Pharmacy

• Medication Allergies or Sensitivities: If you have a medication allergy or sensitivity, a compounding pharmacy can create an alternative medication that avoids problematic ingredients.
• Unique Dosage Needs: If you require a specific dosage or form of medication that is not available through traditional pharmacies, a compounding pharmacy can create a customized solution.
• Hormone Imbalance: If you’re experiencing hormone imbalances or symptoms, a compounding pharmacy can prepare customized hormone replacement therapies.
• Pediatric or Geriatric Patients: Compounding pharmacies can create medications in forms that are more suitable for pediatric or geriatric patients, such as flavored liquids or topical creams.

Risks and Limitations of Compounding Pharmacies

While compounding pharmacies offer many benefits, there are also risks and limitations to consider:

• Quality Control: Compounding pharmacies may not be subject to the same quality control measures as traditional pharmacies, which can lead to contamination, incorrect dosing, or other errors.
• Sterility and Safety: Compounded medications, especially injectables, can pose a risk of infection or contamination if not prepared properly.
• Lack of FDA Oversight: Compounding pharmacies are not subject to the same level of FDA oversight as traditional pharmaceutical manufacturers, which can lead to inconsistent quality and efficacy.
• Insurance Coverage: Compounded medications may not be covered by insurance, leaving patients with higher out-of-pocket costs.

Important Limitations of Compounding Pharmacies

• Compounding Only: According to the FDA, compounding pharmacies are only allowed to prepare medications that:
  • Are not commercially available
  • Are for a specific patient based on a physician’s prescription
  • Are prepared in limited quantities
• No New Drug Creation: Compounding pharmacies are not allowed to create new drugs or medications that are not already approved by the FDA.
• No Bulk Compounding: Compounding pharmacies are not permitted to compound medications in bulk quantities for resale.

What to Look for in a Compounding Pharmacy

• Accreditation: Look for a pharmacy that is accredited by a reputable organization, such as the American Society of Health-System Pharmacists (ASHP) or the National Accreditation Board for Compounding Pharmacies (NABCP).
• Licensure: Ensure the pharmacy is licensed by the state board of pharmacy and meets all regulatory requirements.
• Quality Control: Check if the pharmacy has a robust quality control program and performs outside testing of final products to ensure the accuracy and safety of their compounded medications.
• Transparency: Choose a pharmacy that is transparent about its compounding processes, ingredients, and quality control procedures.

Compounding pharmacies can offer valuable customized medication solutions, but it’s crucial to understand the benefits and risks associated with these pharmacies. By being informed and doing your research, you can make an educated decision about whether a compounding pharmacy is right for you. Always consult with your healthcare provider or pharmacist to discuss your options and ensure that you’re receiving the best possible care.