…attention to whether a pharmacy may not have “adequate assurance of sterility.” The Guidance is silent concerning the permissibility of office use compounding – even for non-sterile drug preparations –…

…outside of the record (typically publically available state pharmacy board records) without taking official notice and providing the respondent an opportunity to challenge those findings. We asserted that this practice…

…all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs….

…pharmacy compounding of drugs that are commercially available and approved by FDA. See FDA, Compliance Policy Guide 460.200 – Pharmacy Compounding.  Please refer to our blog posting of March 31….

By Ricardo Carvajal – Pharmacists Planning Service, Inc. (“PPSI”), a California-based “nonprofit public health, consumer, pharmacy education organization,” submitted a citizen petition asking FDA to make St. John’s Wort (“SJW”)…

…be promoted absent authorization from the Veterans Integrated Service Network (“VISN”) Pharmacy Executive and the Chief of Pharmacy of the VA facility. The proposed rule would impose a number of…

…dispense the drug.  According to the citizen petition, some manufacturers have refused to certify a Kaiser pharmacy for no reason other than the fact that the manufacturer has “contracted” with…

…announcement is contrary to FDA’s long-standing policy to not permit pharmacy compounding of drugs that are commercially available and approved by FDA.  See FDA, Compliance Policy Guide 460.200 – Pharmacy…

…legitimate medical and pharmaceutical need exists.”  The Act also encourages pharmacists to err on the side of caution – that is, refusing to dispense – by providing that “[a] pharmacy…

…compounding pharmacies has been with regard to Signature Pharmacy, Inc. (Signature) which is also based in Florida. Signature has been aggressively defending itself in federal and state court actions for…

…the prescription refill reminder program, where manufacturers pay a service fee to a chain pharmacy to distribute reminders to the pharmacy’s patients when it is time to refill the manufacturer’s…

The International Conference on Drug Development (“ICD2”), formerly known as the International Industrial Pharmacy Conference, continues its annual tradition of offering an informal forum for the exchange of ideas concerning…

…advocacy and pharmacy groups. Several pharmacy groups including the National Association of Chain Drug Stores and the Generic Pharmaceutical Association, and the American Medical Association, have expressed concerns that rescheduling…

…Medical Center, 535 U.S. 357 (2002) striking down as unconstitutional certain provisions of FDC Act § 503A concerning pharmacy compounding, is generally not to permit pharmacy compounding of drugs that…

…paper prescriptions.  See 75 Fed. Reg. 16,236 (March 31, 2010).  DEA requires that any electronic prescription application or pharmacy application used for EPCS must be reviewed, tested and determined by…