• Medications are compounded specifically for individual patients, based on a prescriber’s order.

• In most states, 503A pharmacies cannot compound medications for office use (exceptions may apply depending on state laws).

• They cannot distribute compounded medications in bulk across statelines unless they register as a 503B outsourcing facility.

• All compounding must follow quality and safety standards set bythe United States Pharmacopeia (USP), including:

• USP <795> – Non-sterile compounding

• USP <797> – Sterile compounding

• USP <800> – Handling hazardous drugs

503A pharmacies like ours play an essential role in meeting the unique needs of patients who require personalized medication solutions.

503A pharmacies are regulated by several agencies to ensure patient safety, quality, and compliance with the law. Oversight may vary slightly by state, but generally includes:

• State Boards of Pharmacy – The primary regulatory body for 503A pharmacies. They handle pharmacy licensure, conduct routine inspections, and enforce state practice standards.

• U.S. Food and Drug Administration (FDA) – While the FDA has authority over 503A pharmacies, it typically only conducts inspections if there's a reported safety concern or a violation of federal law.

• Drug Enforcement Administration (DEA) – If the pharmacy compounds or dispenses controlled substances, the DEA oversees compliance with federal controlled substance regulations.

• State Departments of Health – In some states, these departments may also play a role in regulating certain pharmacy operations or public health-related aspects.

• USP <795> – Non-sterile compounding (e.g., creams, capsules)

• USP <797> – Sterile compounding (e.g., injections, eye drops)

• USP <800> – Safe handling of hazardous drugs (e.g., chemotherapy)

• FDA Guidance – Includes documents such as Insanitary Conditions at Compounding Facilities, which help guide best practices to prevent contamination and protect patient safety.

• Good Compounding Practices – Modeled after Good Manufacturing Practices (GMP), these provide structure for quality assurance in the pharmacy setting, tailored specifically to the needs of compounding.

At our pharmacy, we stay up to date with all applicable regulations to ensure our patients receive safe, high-quality compounded medications.

503A pharmacies must meet a range of legal and quality standards to ensure the safety and effectiveness of compounded medications. These include:

• State Pharmacy Laws and Regulations – Each state sets rules for how pharmacies operate, including licensing, staffing, and compounding practices.

• Section 503A of the Federal Food, Drug, and Cosmetic Act (FDCA) – This federal law governs how traditional compounding pharmacies operate and outlines requirements for patient-specific compounding.

• United States Pharmacopeia (USP) Standards – These national standards ensure safe and consistent compounding practices:

Our pharmacy strictly follows these standards to ensure we provide safe, high-quality, and compliant medications for every patient.

Subcutaneous injections deliver medication into the fatty layer just under the skin. They're commonly used for medications like insulin, semaglutide, and tirzepatide. Here’s a step-by-step guide:

‍What You’ll Need:

• Medication vial 

• Alcohol swab

• 1 mL syringe with a 27–30 gauge needle

• Sharps disposal container

Common Injection Sites:

• Abdomen (stay at least 2 inches away from the belly button)

• Outer upper arm

• Front of thighs

• Upper buttocks or “love handle” area

Step-by-Step Instructions:

• Wash your hands thoroughly with soap and water.

• Clean the injection site with an alcohol swab and let it air dry.

• If using a vial:

  · Clean the vial’s rubber stopper with alcohol.

  · Draw air into the syringe equal to your dose.

  · Inject the air into the vial, then draw up the correct dose.

  · Remove any air bubbles from the syringe.

• Pinch the skin to lift the fatty tissue.

• Insert the needle at a 45° or 90° angle, depending on your body type and your provider’s instructions.

• Inject the medication slowly and steadily.

• Withdraw the needle and apply gentle pressure with a clean cotton ball or tissue—do not rub.

• Dispose of the needle in a proper sharps container.

Helpful Tips:

• Rotate injection sites to avoid lumps or scar tissue (lipodystrophy).

• Never reuse needles or syringes.

• Store your medication as directed (many need refrigeration).