Pharmacy
Hydrocodone Combination Products Moving to Schedule II
On August 22, the Drug Enforcement Agency (DEA) published a final rule to move hydrocodone combination products (HCPs) from Schedule III to Schedule II. The change takes effect on October 6, 2014. Under the finale rule, all Schedule II requirements with respect to security, labeling and packaging, inventory, record keeping and reporting, etc., will apply to…
Read MoreFDA'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 MoreNotice to All Licensed Colorado Pharmacists and Registered DEA Prescribing Practitioners
All Colorado licensed pharmacists and registered DEA prescribing practitioners are required to register an individual user account with Colorado’s Prescription Drug Monitoring Program (PDMP) pursuant to CRS 12-42.5-403 of the Pharmacy, Pharmacy Businesses and Pharmaceuticals Practice Act. The following due dates for each profession are: Pharmacists and DEA-registered Advanced Practice Nurses: September 30, 2014 DEA-registered…
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 MoreThe Push for Bilingual Prescription Labels in California
The California Board of Pharmacy (Board), which regulates approximately 6,500 community pharmacies and 500 hospital pharmacies statewide, and over 140,000 entities holding pharmacy licenses, is currently considering new regulations that would require all pharmacies in California to provide translated labels on prescription bottles. With an estimated 44% of all Californians speaking a language other than…
Read MoreCorresponding Responsibility: A Pharmacist's Obligation to Understand
Why is understanding corresponding responsibility important to me as a practicing pharmacist? In short, enforcement actions against pharmacies occur most often when pharmacists fail to exercise their corresponding responsibility as addressed by the Drug Enforcement Agency (DEA) in its regulations (21 CFR 1306.04) which state: “A prescription for a controlled substance to be effective must be…
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…
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