Archive for August 2014
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 MoreColorado State Board of Pharmacy Legislation Update: Modifications to the Electronic Prescription Drug Monitoring Program
HB14-1283 – Modify Prescription Drug Monitoring Program HB14-1283 makes the following modifications to the electronic prescription drug monitoring program: The dissemination of automatic reports to prescribers and pharmacies when a patient meets a defined threshold that takes into account the number of prescribers and pharmacies visited within a certain timeframe. Reports will start in September…
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 More