Legal and Regulatory Requirements
California Operations

• Basic Businesses
  • Business License
  • Sales Tax Permit
  • Emergency Preparedness Program
  • Fictitious Name Statement
  • Workplace Safety Review
  • Injury/Illness Prevention Program (SB198)
     
• Disposable and Incontinence Product Sales
  • Medi-Cal requirements (AB2622, Baker)
     
• Legend Items, disposable or reusable
  • Exemptee Licensee required on staff - Department of Health Services Food and Drug Branch

HME and Respiratory Equipment

• Home Medical Device Retail Facility License - California Department of Public Health (CDPH) Food and Drug Branch. - http://www.cdph.ca.gov/certlic/Pages/HMDRLicenseApplication.aspx
• CHP Hazardous Material Transportation License - http://www.chp.ca.gov/publications/pdf/chp361e.pdf
  Insurance
• Toxic Enforcement Act (Prop. 65)
• Bloodborne Pathogens
• OSHA Hazardous Communications Program http://www.osha.gov/dsg/hazcom/solutions.html 
• complete MSDS listings

1. Oxygen Systems and products
   • Respiratory Care Practitioner on staff (mandatory if performing assessments)
   • CHP Hazardous Material License
   • CHP BIT Program
   • HazMat rules, i.e. manifest, hours, etc.
   • DMV Pull Program for all drivers
   • Drivers
     • Require special license endorsements
     • training and physicals
     • drug testing suggested
   • FDA registration for LOX and CMG transfilling
   • CA FDA registration for bulk LOX, CMG transfill
   • CA Drug Manufacturer License for bulk LOX, CMG
   • County HazMat registration/license
      
2. Clinical Respiratory Services
   • CA Home Health Agency License
      
3. Home Infusion Services
   • Pharmacy license
   • DEA registration
   • Hazardous Waste generator registration
   • Hazardous Waste disposal contract
      
4. Prosthetic & Orthotic Supplies
   • NARD Certification; or
   • ABC Certification