Contact Us
Categories
- Medical Spas
- medical billing
- No Surprises Act
- Mandatory vaccination policies
- Workplace health
- Coronavirus Aid, Relief and Economic Security Act
- Code Enforcement
- Department of Labor ("DOL")
- Employment Law
- FFCRA
- CARES Act
- Nursing Home Reform Act
- COVID-19
- SB 150
- Acute Care Beds
- Clinical Support
- Coronavirus
- Emergency Medical Services
- Emergency Preparedness
- Families First Coronavirus Response Act
- Family and Medical Leave Act (“FMLA”)
- KBML
- medication assisted therapy
- Department of Health and Human Services
- Legislative Developments
- Corporate
- United States Department of Justice ("DOJ")
- Employee Contracts
- Non-Compete Agreement
- Opioid Epidemic
- Sexual Harassment
- Health Resource and Services Administration
- Litigation
- Medical Malpractice
- House Bill 333
- Senate Bill 79
- locum tenens
- Physician Prescribing Authority
- Senate Bill 4
- Chronic Pain Management
- HIPAA
- Prescription Drugs
- "Two Midnights Rule"
- 340B Program
- EHR Systems
- Hospice
- Kentucky minimum wage
- Minimum wage
- Skilled Nursing Facilities (“SNFs”)
- Uncategorized
- Drug Screening
- Electronic Health Records (“EHR")
- ICD-10
- Mental Health Care
- Primary Care Physicians ("PCPs")
- Urinalysis
- Affordable Insurance Exchanges
- Compliance
- Department of Health and Human Services (HHS)
- Federally Qualified Health Centers (“FQHCs”)
- Fraud
- Health Care Fraud
- HIPAA Risk Assessment
- HPSA
- KASPER
- Kentucky Board of Medical Licensure
- Kentucky’s Department for Medicaid Services
- Office for Civil Rights ("OCR")
- Office of Inspector General of the United States Department of Health and Human Services (OIG)
- Pharmacists
- Physician Assistants
- Qui Tam
- Rural Health Centers (“RHCs”)
- Stark Laws
- Telehealth
- Accountable Care Organizations (“ACO”)
- Affordable Care Act
- Alternative Payment Models
- Anti-Kickback Statute
- Centers for Medicare & Medicaid Services (“CMS”)
- Certificate of Need ("CON")
- Charitable Hospitals
- Data Breach
- Electronic Protected Health Information (ePHI)
- False Claims Act
- Fee for Service
- Health Information Technology for Economic and Clinical Health Act (HITECH Act)
- Health Insurance Portability and Accountability Act of 1996 (HIPAA)
- Health Professional Shortage Area ("HPSA")
- Hospitals
- HRSA
- Limited Services Clinics
- Medicaid
- Medical Staff By-Laws
- Medically Underserved Area ("MUA")
- Medicare
- Mid-Level Practitioners
- Part D
- Patient Protection and Affordable Care Act (“ACA”)
- Rural Health Clinic
- American Telemedicine Association (“ATA”)
- Criminal Division of the Department of Justice (“DOJ”)
- Health Care Fraud Prevention and Enforcement Action Team (“HEAT”)
- Hydrocodone
- Kentucky Board of Nursing
- Kentucky Pharmacists Association
- Qualified Health Care Centers (“FQHC”)
- Telemedicine
- Webinar
- Agreed Order
- APRNs
- Chain and Organization System (“PECOS”)
- Douglas v. Independent Living Center of Southern California
- Drug Enforcement Agency ("DEA")
- Hinchy v. Walgreen Co.
- Jimmo v. Sebelius
- Maintenance Standard
- Overpayments
- United States ex. Rel. Kane v. Continuum Health Partners
- Vitas Innovative Hospice Care
- 2014 Medicare Physician Fee Schedule (“PFS”)
- 501(c)(3)
- All-Payer Claims Database ("APCD")
- Chiropractic services
- Chronic Care Management
- Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)
- Compliance Officer
- Compounding
- CPR
- Drug Quality and Security Act (“DQSA”)
- Emergency Rooms
- Enrollment
- Essential Health Benefits
- House Bill 3204
- ICD-9
- Kentucky Senate Bill 7
- Medicare Part D
- Minors
- New England Compounding Center ("NECC")
- Ophthalmological services
- Outsourcing facility
- Physician Compare website
- Re-validation
- Sustainable Growth Rate (“SGR”)
- Texting
- Affinity Health Plan
- Appeal
- Arbitration
- Cadillac tax
- Centers for Disease Control and Prevention
- Community health needs assessment (“CHNA”)
- Condition of Participation ("CoP")
- Denied Claims
- Department of Medicaid Services’ (“DMS”)
- Dispenser
- Employer Mandate
- Federation of State Medical Boards (“FSMB”)
- Food and Drug Administratio
- Form 4720
- Grace Period
- Health Professional Shortage Areas (“HPSA”)
- HealthCare.gov
- Home Health Prospective Payment System
- Home Medical Equipment Providers
- Hospitalists
- Individual mandate
- Inpatient Care
- Kentucky Health Benefit Exchange
- Kentucky Medical Practice Act
- Kindred v. Cherolis
- Kynect
- Licensure Requirements
- LLC v. Sutter
- Long-term care communities
- Long-Term Care Providers ("LTC")
- Low-utilization payment adjustment ("LUPA")
- Medicare Shared Saving Program (MSSP)
- Mobile medical applications ("apps")
- Model Policy for the Appropriate Use of Social Media and Social Networking in Medical Practice (“Model Policy”)
- National Drug Code ("NDC")
- National Institutes of Health
- Network provider agreement
- Nonprofit hospitals
- Nonroutine medical supplies conversion factor (“NRS”)
- Payors
- Personal Service Entities
- Physician Payments
- Physician Recruitment
- Physician shortages
- Ping v. Beverly Enterprises
- Power of Attorney ("POA")
- Prescriber
- Qualified Health Plan ("QHP")
- Quality reporting
- Residency Programs
- Social Media
- Spousal coverage
- State Health Plan
- Upcoding
- UPS
- “Superuser”
- "Plan of Correction"
- Advanced Practice Registered Nurses
- Audit
- Autism/ASD
- Business Associate Agreements
- Business Associates
- Call Coverage
- Daycare centers
- Decertification
- Division of Regulated Child Care
- Doe v. Guthrie Clinic
- EHR vendor
- Employer Group Health Plans
- ERISA
- Fair Labor Standards Act (FLSA)
- False Billings
- Genetic Information Nondiscrimination Act ("GINA")
- Group Purchasing Organizations ("GPO")
- Health Reform
- House Bill 104
- Intermediate Sanctions Agreement
- Kentucky House Bill 159
- Kentucky House Bill 217
- Licensed practical nurses (LPN)
- List of Excluded Individuals and Entities
- Meaningful use incentives
- Medicare Administrative Coordinators
- Medicare Benefit Policy Manual
- Nurse practitioners (NP)
- Office of the National Coordinator for Health Information Technology (“ONC”)
- Part A
- Part B
- Patient Autonomy
- Patient Privacy
- Personal Health Information
- Provider Self Disclosure Protocol
- Registered nurses (RN)
- Self-Disclosure Protocol
- Senate Bill 39
- Senate Finance Committee Report
- State Medicaid Expansion
- Statement of Deficiency ("SOD")
- Trade Association Group Coverage
- Abuse and Waste
- Center for Disease Control
- Compliance Programs
- Consumer Operated and Oriented Plan programs (“CO-OPS”)
- Critical Access Hospitals (“CAHs”)
- Essential Health Benefits (“EHBs”)
- Healthcare Information and Management Systems Society (HIMSS)
- Kentucky Cabinet for Health and Family Services
- Kentucky Health Care Co-Op
- Kentucky Health Cooperative (“KYHC”)
- Kentucky Primary Care Centers (“PCCs”)
- Managed Care Organizations (“MCOs”)
- Medicare Audit Improvement Act of 2012
- Occupational Safety and Health Administration (“OSHA”)
- Recovery Audit Contractors (“RAC”)
- Small Business Health Options Program (“SHOP”)
- Sunshine Act
- Employee Agreement
- Free Conference Committee Report
- Health Care Fraud and Abuse Control Program
- House Bill 1
- House Bill 4
- Kentucky “Pill Mill Bill”
- Pain Management Facilities
- Health Care Law
- Health Insurance
- Healthcare Regulation
McBrayer Blogs
Controlling Compounding: The Drug Quality and Security Act, Part II
Earlier this week we discussed the new Drug Quality and Security Act (“DQSA”) that establishes and regulates a new class of compounding pharmacies called “outsourcing facilities.” To qualify as an “outsourcing facility”, the entity must compound sterile drugs with or without patient prescriptions and comply with the DQSA’s new rules, including registering with the FDA. An outsourcing facility is not required to be a licensed pharmacy. Registering as an outsourcing facility is completely voluntary, but entities that do not register may be prohibited from compounding drugs for office use and will be required to obtain prescriptions for individual patients.
Annual registration as an outsourcing facility is required and is accompanied by a $15,000 registration fee (unless the facility has under $1 million dollars in sales, in which case the fee is $5,000). The facility must report the drugs that are being compounded to the FDA in June and December of each year. Facilities that do not register will be subject to the FDA rules on new drug application and approval, adequate use directions, and drug supply chain security requirements.
The FDA will conduct “risk-based” inspections of outsourcing facilities to determine inspection frequency based on several factors, such as the facility’s compliance and recall history or inherent risk of drugs being compounded. If a facility is subject to reinspection more than once in any given fiscal year, a fee will be required. Failure to pay the registration or reinspection fee will result in all drugs compounded by the facility being deemed “misbranded” under the Food Drug and Cosmetics Act.
Outsourcing facilities are prohibited from compounding certain drugs. Any drugs compounded by the facilities must be labeled in a manner that prominently identifies the drug as a compound drug product. The facilities are subject to the same record retention and adverse event reporting requirements as traditional drug manufacturers.
The DQSA does not regulate traditional pharmacy compounding of non-sterile drugs pursuant to patient prescription and state boards of pharmacy will retain their oversight authority of such activity. To monitor the interplay between FDA and State regulation of compounding pharmacies, the DQSA commissions a Government Accountability Office study to be submitted to Congress within three years that includes a review of pharmacy compounding by state and an evaluation of the effectiveness of the communication between the FDA and state pharmacy boards.
It will be interesting to see if pharmacies believe the benefits of registering as an outsourcing facility are worth the substantial registration fee and additional compliance obligations. And while the DQSA leaves traditional pharmacy compounding untouched for now, changes in regulations and standards for those facilities may soon be on the horizon.
Services may be performed by others.
This article does not constitute legal advice.