Pharmacy Updates
Colorado Pharmacy Legislation Update: Modifying the PDMP
HB14-1283: Modify Prescription Drug Monitoring Program HB14-1283 modifies the electronic prescription drug monitoring as follows: 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 started in September 2014. Allows a prescribing practitioner…
Read MoreCalifornia Bilingual Prescription Label Update
How often are pharmacy prescription label instructions translated incorrectly? Should pharmacists who are fluent only in English be required to fill prescriptions with instructions in a foreign language? Who counsels the non-English speaking patients regarding their prescription(s) and/or side effects of the medication(s)? Who is ultimately liable for the incorrect translated instructions in the event…
Read MoreGeorgia Board of Pharmacy Requiring Non-Resident Pharmacy Licensure
Until recently, the State of Georgia did not require non-resident pharmacies to obtain a license to ship medications into the State of Georgia. However, at the Georgia Board of Pharmacy’s (GBOP) September 2014 meeting, the GBOP enacted rules requiring non-resident pharmacies to obtain a non-resident pharmacy license before dispensing medications into the State of Georgia.…
Read MorePharmacists Must Ensure Prescription Orders are Issued for a Legitimate Medical Purpose by an Authorized Prescriber and Have a Recognized Medical Utility or Application
As discussed previously on the Baer Law Blog, corresponding responsibility remains one of the most misunderstood or unknown concepts found in the Drug Enforcement Administration’s (DEA) regulations. The DEA’s regulations (21 CFR 1306.04) regarding corresponding responsibility state: A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an…
Read MoreCountdown to October 6, 2014: Hydrocodone Containing Product Reclassification
As discussed previously here on the Baer Law Blog, after more than a decade of debate, hydrocodone containing products (HCPs) are being reclassified from Schedule III to the more restrictive Schedule II controlled substances category starting October 6, 2014. HCPs are the most prescribed drug in the United States, second only to levothyroxine, a thyroid…
Read MoreNotice to Florida Licensed Non-Resident Pharmacies
Beginning October 1, 2014, Florida requires all non-resident pharmacies to obtain a Nonresident Sterile Compounding Permit in order to ship, mail, deliver or dispense in any manner, a compounded sterile product into the State of Florida. Nonresident pharmacies that are compounding sterile products under their current Florida pharmacy permit may continue to do so if:…
Read MoreUpdated Controlled Substances Disposal Requirements: Effective October 9, 2014
Historically, under the Controlled Substance Act (CSA), patients could only dispose of unused controlled substances themselves or deliver the controlled substances to law enforcement officials. In October 2010, the Secure and Responsible Drug Disposal Act (Disposal Act) of 2010 was enacted with the goal of facilitating more convenient and secure disposal options. The Disposal Act…
Read MoreDisposing of Unused Controlled Substances: DEA Expands Prescription Drug Take-Back
In early October, disposing of unused medications, including controlled substances, will likely get much easier as the Drug Enforcement Agency (DEA) is expanding the options to collect medications with the hopes that the rule expansion will discourage individuals from simply flushing drugs down the toilet, throwing drugs away or leaving drugs in medicine cabinets. With…
Read MoreHydrocodone 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…
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