Posts Tagged ‘compounding’
FDA's Guidance on Compounding for Human Use
As discussed previously on the Baer Law Blog, Title I of the Drug Quality and Security Act (DQSA) gives the Food and Drug Administration (FDA) new powers to oversee drug compounding. Section 503A of the DQSA sets out certain requirements for traditional compounding, while Section 503B creates a new entity called outsourcing facilities. This blog…
Read MoreColorado State Board of Pharmacy Legislation Update No. 2
HB14-1083 – Acute Treatment Units Stock Medications HB14-1083 – Acute treatment units (ATU) provide medically supervised behavioral health treatment services to individuals who suffer from psychiatric disorders. Current law does not allow an ATU to have an onsite stock of medications. The bill allows an ATU to procure, store, order, dispense, and administer prescription medications and to…
Read MoreCompounded Drugs and Medicare Part B
Medicare Part B generally covers most medically necessary doctors’ services. These services can include some limited outpatient prescriptions and biologicals, preventative care, durable medical equipment, hospital outpatient services, laboratory tests, x-rays, mental health care and some home health. Providers must timely submit claims to a Medicare Administrative Contractor (MAC) using Healthcare Common Procedure Coding System…
Read MoreOutsourcing Facilities: Section 503B
The Drug Quality and Security Act (DQSA) can be separated into two sections: Title I addresses drug compounding and Title II relates to drug supply chain security. Section 503A of the Food, Drug and Cosmetic Act (FDCA) addresses compounding requirements, where as Section 503B defines and describes “outsourcing facilities.” Outsourcing Facilities are defined as a…
Read MoreCompounding: Section 503A Changes
The regulatory landscape for pharmacy compounding has changed immensely since the passage of the Drug Quality and Security Act (DQSA) in November 2013. Historically, the Food and Drug Administration (FDA) has not strictly enforced pharmacy compounding under the FDA Modernization Act of 1997. However, the passage of the DQSA, which updated Section 503A of the…
Read MoreEnhancing FDA Communications: DQSA Update
The Food and Drug Administration (FDA) was granted some new authority this week by the Department of Health and Human Services (DHHS), its parent organization. The new authority, though not unexpected or substantial, pertains to the Drug Quality and Security Act (DQSA) which was passed in late 2013 in response to the deadly New England…
Read MoreDrug Quality and Security Act: Title II – Track and Trace System
The Drug Quality and Security Act (DQSA) was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. Title II of the DQSA seeks to reduce drug shortages, theft, counterfeiting and drug diversion by modernizing existing federal law and replacing current state…
Read MoreDrug Quality and Security Act: Title I – Compounding
On November 23, 2013, the President signed the Drug Quality and Security Act (DQSA) into law. As discussed previously on the Baer Law Blog, the legislation was designed to clarify the Food And Drug Administration’s (FDA) oversight authority over drug compounding and update the federal drug tracking and tracing system. The goal of Title I…
Read MoreFDA Preparing a List of Bulk Drug Substances for Compound Drug Products
The Food and Drug Administration (FDA) is preparing a list of bulk drug substances that outsourcing facilities may use to compound drug products in accordance with Section 503B of the Food, Drug and Cosmetic Act (FDC Act). Requests for electronic and written nominations ended in early March 2014. Section 503B of the FDC Act defines…
Read MoreFDA Releases Draft Guidance on Section 503B Fees for Outsourcing Facilities.
Section 503B of the Federal Food, Drug and Cosmetic Act (FDCA) created a new Food and Drug Administration (FDA) regulated entity called an ‘outsourcing facility.’ As discussed previously on the Baer Law Blog, a registered outsourcing facility is permitted to compound sterile drugs for human use with or without a prescription after voluntarily registering with…
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