
Emerald Compounding Pharmacy
Regulatory Framework
FDA Oversight:
Regulated under Section 503A of the FD&C Act
Must comply with FDA current good manufacturing practices (cGMP)
Subject to FDA inspections and enforcement
Required to report adverse events
Must follow USP compounding standards
State Regulation:
Licensed and regulated by state boards of pharmacy
Must comply with state pharmacy laws
Regular state inspections required
Pharmacist licensure requirements
Facility and equipment standards
Patient-Specific Prescriptions: Must compound only pursuant to patient-specific prescriptions from licensed practitioners
No Large-Scale Manufacturing: Cannot compound large quantities for distribution without patient-specific prescriptions
Interstate Commerce Limitations: Can ship across state lines only if in compliance with both states' laws
Bulk Drug Substances: Must use FDA-approved drugs or bulk substances from the FDA's bulk list
Sterile Compounding: Must follow USP <797> standards for sterile preparations
Quality Assurance: Implement comprehensive quality control and testing procedures
Record Keeping: Maintain detailed records of all compounding activities
Bioidentical hormones (estradiol, progesterone, testosterone)
Thyroid hormones (T3, T4, desiccated thyroid)
Growth hormone and peptides
Customized dosage forms and strengths
Topical gels, creams, and ointments
Capsules with specific dosages
Sublingual tablets and troches
Injectable preparations
Topical pain relief compounds
Custom-strength analgesics
Multi-ingredient pain formulations
Alternative delivery methods
NAD+ and peptide therapies
Vitamin and mineral injections
Antioxidant formulations
Immune support preparations
Customized dosage strengths
Alternative delivery methods
Removal of allergens or inactive ingredients
Combination of multiple medications
Patient-specific formulations
Access to discontinued medications
Unavailable commercial strengths
Specialized pediatric formulations
Veterinary applications
Cost-effective alternatives
Patient-specific prescriptions required
State-licensed and regulated
Lower volume production
Direct patient relationship
More flexible formulation options
Can produce without patient-specific prescriptions
FDA-registered facilities
Higher volume manufacturing
Supply hospitals and clinics
More stringent cGMP requirements
USP Standards: Compliance with United States Pharmacopeia chapters 795 (non-sterile) and 797 (sterile compounding)
Environmental Controls: Proper temperature, humidity, and air quality controls in compounding areas
Personnel Training: Comprehensive training programs for all compounding staff
Equipment Calibration: Regular calibration and maintenance of all compounding equipment
Testing and Analysis: Potency testing, sterility testing, and endotoxin testing when required
Stability Studies: Beyond-use dating based on stability data and testing
Documentation: Detailed batch records and quality control documentation
State licensing and regulatory compliance
Experience with specific medication types
Quality assurance programs and testing
Pharmacist credentials and expertise
Patient and physician testimonials
Facility accreditation (PCAB, ACHC)
What quality testing do you perform?
Can you provide certificates of analysis?
What are your beyond-use dating practices?
Do you have experience with my specific medication?
What are your storage and shipping procedures?
How do you handle adverse event reporting?
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