Compounding Legalities

Beyond-Use Dating (BUD)

All compounded medications are assigned a beyond-use date (BUD) to ensure the product conforms to its labeled strength. Unlike commercially manufactured drugs, compounded preparations are made in smaller batches and do not undergo long-term stability testing. For that reason BUDs are determined based on USP guidelines, taking into account the type of compound, its dosage form, and whether water is present in the inactive ingredients used.

In general, compounds that contain water have shorter beyond-use dates because moisture increases the rate of chemical degradation. Non-aqueous formulations, such as capsules or ointments, may have longer BUDs. Every compounded formula is evaluated individually and assigned a beyond-use date timeframe for patient use.

Medical Necessity for Compounding

Compounding is intended to meet specific patient needs that cannot be fully addressed by commercially available medications. When a commercially manufactured version of the same medication and strength exists, federal and state regulations require a documented medical reason for using a compounded alternative. This rationale can be easily documented on prescription hard copies.

Patients sometimes ask whether we can compound a medication that is already commercially available because the manufactured version is expensive or not covered by their insurance. While we understand these concerns, cost alone is not a reason to compound a medication. Compounding is appropriate when there is a medical need, such as an allergy to certain ingredients, difficulty using the available dosage form, the need for a different strength, or when multiple medications must be combined into one customized treatment. This helps ensure that compounding is used to provide safe, individualized care based on each patient’s specific needs.

Coastal is a 503A Compounding Pharmacy

Coastal Pharmacy & Wellness operates as a 503A compounding pharmacy, meaning we compound medications only pursuant to patient-specific prescriptions. Each compound is prepared for an identified individual based on a valid prescription from a licensed prescriber. Under 503A regulations, we cannot compound medications for office stock or for general resale by medical offices or by other practitioners. This framework helps maintain a direct link between the prescriber, the patient, and the pharmacist compounding the medication. This reinforces safety, accountability, and appropriate clinical oversight.

FDA Approval and Compounded Medications

Compounded medications are not reviewed or approved by the U.S. Food and Drug Administration (FDA). Instead, they are prepared by a licensed pharmacist in response to a prescription from a healthcare provider to meet an individual patient’s specific needs. While compounded medications are made using established pharmaceutical standards and quality ingredients, they do not undergo the same FDA approval process as commercially manufactured drugs. Your healthcare provider and pharmacist work together to determine whether a compounded medication is appropriate for you.

Your Safety and Understanding Matter to Us

Patient safety and education are central to our compounding practice. We work closely with prescribers to prepare medications tailored to each patient’s needs, and we provide counseling to help patients understand how to use, store, and handle their compounded medications. Patients are encouraged to ask questions, follow prescribed directions carefully, and report any side effects or concerns to their healthcare provider. This collaborative approach helps support safe, effective, and individualized care.

Controlled Substances and Regulatory Compliance

Compounded medications that contain controlled substances are prepared in strict accordance with the Federal Controlled Substances Act and all applicable state Board of Pharmacy regulations. These medications are subject to additional safeguards, including prescribing, documentation, and dispensing requirements, to help ensure appropriate use and prevent misuse or diversion. We work closely with prescribers and follow all regulatory guidelines to maintain compliance while prioritizing patient safety and responsible medication use.