REGULATORY COMPLIANCE

Bare Compounding Pharmacy complies with all applicable federal and state regulations, including those established by:

• California State Board of Pharmacy
• U.S. Food and Drug Administration

We operate under strict regulatory frameworks to ensure patient safety, product quality, and professional accountability.

• Every compounded medication is prepared only after receipt of a valid prescription for an identified patient
• Each formulation is customized to meet individual medical needs
• Compounded medications are not mass-produced or sold as retail products

This practice aligns with Section 503A of the Federal Food, Drug, and Cosmetic Act, which permits licensed pharmacists to compound medications for individual patients pursuant to valid prescriptions.

In accordance with California law, compounded medications are not prepared in advance, except in limited cases based on historical prescribing patterns.

Compounding pharmacies in California must comply with Title 16 of the California Code of Regulations under the oversight of the Board of Pharmacy.

Key regulations include:

Article 4.5 – Compounding (Sections 1735 – 1735.8)

• Defines compounding as altering dosage forms, strengths, or combining ingredients to prepare patient-specific medications.

Section 1735 – Compounding in Licensed Pharmacies

• Compounding must occur in a licensed pharmacy under the supervision of a pharmacist.

Section 1735.2 – Compounding Limitations and Requirements

• Requires a valid patient-specific prescription before compounding (with limited anticipatory compounding allowed).
• Prohibits compounding drugs withdrawn from the market for safety reasons.
• Limits compounding of drugs that are copies of commercially available products unless clinically justified.

Master Formula Requirements

• Pharmacies must maintain detailed formulation records, including ingredients, equipment, procedures, and quality checks.

Quality and Safety Standards

• Pharmacists are responsible for maintaining the integrity, potency, quality, and labeled strength of compounded preparations.

Bare Compounding Pharmacy follows best practices including:

• USP compounding standards (USP <795>, <797>, <800> where applicable)
• Board of Pharmacy compounding requirements
• Comprehensive quality assurance procedures
• Ingredient verification and sourcing standards
• Beyond-use dating based on scientific references and compounding guidelines

Our pharmacists collaborate closely with prescribers to:

• Develop custom formulations
• Adjust dosage forms (capsules, creams, troches, suspensions, etc.)
• Remove allergens or inactive ingredients
• Modify strengths or delivery systems
• Address patient-specific therapeutic needs