News
Notice 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 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 MoreFedEx and Online Pharmacy Issues
The blitz against online pharmacies was launched in 2005 and has resulted in dozens of arrests, thousands of websites being shut down, and tens of millions of dollars and medications seized worldwide as investigators expand their search. FedEx Corporation (FedEx) appears to be the latest company accused in a federal probe involving illegal online pharmacies.…
Read MoreBiosimilar and Interchangeable Products: Massachusetts Enacts New Law
Biosimilar drugs are biological drugs that are similar but not identical to a referenced biological or branded product. Approximately four years ago, Congress passed the “Biologics Price Competition and Innovation Act” (BCPIA) which granted the Food and Drug Administration (FDA) a pathway for approval of biological products that are interchangeable with a referenced or branded…
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 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…
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