Specialized Compounding
Patient-specific dosing, precisely formulated
1Elevan Bio is a licensed 503A compounding pharmacy. When commercially available medications don't meet a patient's clinical needs, our experienced compounding team works directly with providers to prepare individualized formulations.
Many Americans rely on compounded medications on a daily basis to meet their specific health needs. Some common reasons behind the use of compounded medications include allergies to commercial drug ingredients, alternative dosage forms, or doses not commercially available. Our state-of-the-art facility delivers provider-directed, custom therapies with great care and a commitment to quality.
Four Key Reasons Prescribers Choose Compounding
Custom Strength & Dose
Dose strengths not available commercially, including pediatric, geriatric, and low-dose formulations.
Alternate Delivery Forms
Oral liquids, topical preparations, transdermal gels, troches, suppositories, capsules, injectables, nasal preparations, and ophthalmic preparations.
Combination Therapy
Multiple active ingredients in a single preparation to simplify complex drug regimens and improve patient adherence.
Allergen & Excipient Removal
Dye-free, preservative-free, gluten-free, and sugar-free bases for sensitive or allergic patients.
BY THE NUMBERS
Compounded prescriptions are dispensed annually in the U.S.
Source: APC (Alliance for Pharmacy Compounding)
Americans take compounded medications each year
Source: Professional Compounding Centers of America (PCCA)
%
Estimated growth annually of the compounding industry
Source: APC (Alliance for Pharmacy Compounding)
Frequently Asked
Common Questions
How many medications can be compounded?
Compounding pharmacies can prepare medications in hundreds of unique dosage forms and strengths not available commercially, drawing from a formulary of thousands of active pharmaceutical ingredients. The FDA Orange Book lists roughly 20,000+ approved commercially available drug products. The number is essentially limitless, since compounding is by definition customized (different strengths, bases, delivery forms, and combinations).
What is the difference between a 503A and a 503B compounder, and which are you?
503A pharmacies compound on a patient-specific basis in response to a valid prescription for one individual patient. They are primarily regulated by state boards of pharmacy and must comply with USP standards but are exempt from FDA's cGMP manufacturing requirements. 503B compounders, also referred to as outsourcing facilities, produce larger batches without patient-specific prescriptions, are registered with and inspected by the FDA, and must comply with cGMP. 1Elevan Bio is a 503A compounding pharmacy, meaning every preparation we compound is formulated pursuant to a valid prescription for a specific patient.
What is a beyond-use date (BUD), and how is it different from an expiration date?
A beyond-use date (BUD) is the date after which a compounded preparation should not be used. It is assigned by the compounding pharmacist based on the preparation's specific formulation, container, storage conditions, and applicable USP standards. An expiration date, by contrast, is set by a manufacturer after extensive stability testing on a commercially produced batch. BUDs are inherently more conservative because compounded preparations are made in smaller batches without the same long-term stability data. The BUD is printed on every label we dispense.
What does "stability" mean in the context of a compounded preparation?
Stability refers to the ability of a preparation to retain its physical, chemical, antimicrobial, and therapeutic properties within specified limits throughout its BUD period. The five types of stability we evaluate are:
- Chemical — the active ingredient retains its potency and does not degrade
- Physical — appearance, uniformity, and consistency remain acceptable
- Antimicrobial — sterility (for sterile preps) and resistance to microbial growth
- Therapeutic — the preparation continues to deliver the intended clinical effect
- Toxicological — no harmful degradation products form over time
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