Understanding the FDA's Compounding Category System For non-clinical readers, the three-tier classification is worth spelling out plainly: Category 1 substances can be legally compounded by licensed 503A pharmacies (individual prescription-based) and 503B outsourcing facilities (larger-scale production)
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100-02, chapter 15, sections 220.1Conditions of Coverage and Payment for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services, 220.1.2Plans of Care for Outpatient Physical Therapy, Occupational Therapy, or Speech-Language Pathology Services, and 220.1.3Certification and Recertification of Need for Treatment and Therapy Plans of Care, which convey our current policy that all outpatient physical therapy, occupational therapy, and speech-language pathology services are subject to requirements for certification and recertification at 424.24, whether furnished by providers or by suppliers such as therapists in private practice (TPPs)