List the requirements of FDA in opening a pharmacy

Opening a pharmacy involves several regulatory requirements, particularly from the U.S. Food and Drug Administration (FDA) as well as local and state regulations. Here are the key steps and requirements associated with opening a pharmacy:

### 1. **Business Structure and Licensing:**
   - **Business Formation:** Choose a legal structure (LLC, corporation, etc.) for the pharmacy.
   - **State Pharmacy License:** Obtain a pharmacy license from the state board of pharmacy. Each state has its own requirements and processes.

### 2. **Facility Requirements:**
   - **Location Compliance:** Ensure that the physical location complies with local zoning laws and is appropriate for operating a pharmacy.
   - **Building Codes:** The facility must meet building codes for safety and accessibility.
   - **Record Keeping Facilities:** Design spaces for proper storage of medications, including controlled substances, and ensure there are secure storage areas.

### 3. **FDA Compliance:**
   - **Drug Approval and Regulation:** Ensure that all medications dispensed comply with FDA regulations, including safety and efficacy requirements.
   - **NDA or ANDA if applicable:** If compounding or manufacturing, ensure compliance with New Drug Applications (NDA) or Abbreviated New Drug Applications (ANDA).
   - **Labeling Requirements:** Products must be properly labeled as per FDA regulations, including information about active ingredients, warnings, and use instructions.
   - **Pharmacy Registration:** Depending on the services offered, you may need to register as an establishment with the FDA.

### 4. **Pharmacy Operations:**
   - **Inventory Management:** Implement systems for tracking drug inventories, including purchase, storage, and dispensing records.
   - **Handling Controlled Substances:** Register with the Drug Enforcement Administration (DEA) for dispensing controlled substances and comply with storage and record-keeping laws.
   - **Compounding Regulations:** If compounding medications, follow FDA guidelines and state laws regarding compounding practices.

### 5. **Staffing Requirements:**
   - **Pharmacist Licensure:** Employ licensed pharmacists who meet state licensure requirements.
   - **Staff Training:** Ensure appropriate training and onboarding programs in compliance with OSHA and other health and safety regulations.

### 6. **Insurance and Compliance:**
   - **Liability Insurance:** Obtain necessary liability insurance for the pharmacy.
   - **Compliance Programs:** Establish policies and procedures to comply with state and federal regulations, including HIPAA for patient privacy.

### 7. **Consumer Safety and Quality Assurance:**
   - **Quality Assurance Programs:** Implement practices and systems for quality control to ensure patient safety and effective medication management.
   - **Patient Counseling:** Provide counseling and medication management services to patients.

### 8. **Miscellaneous Requirements:**
   - **Taxes and Accounting:** Set up tax identification numbers and accounting systems in compliance with federal and state tax obligations.
   - **Business Licenses:** Obtain any additional local business licenses or permits required by your city or county.

### Final Note:
It’s crucial to consult with legal counsel and professionals familiar with pharmacy regulations to ensure full compliance with all local, state, and federal laws before opening a pharmacy. Each state may have unique laws that must be followed when opening and operating a pharmacy.