No 483.
Professional Compounding Centers Of America, LLC
Jun 11, 2009
No 483.
No 483.
483 issued.
(not in store).
(not in store).
No 483.
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
represents a nationwide collective of compounding pharmacies that provide fulfillment services to physicians participating in topical pain modalities.
We do business in all 50 states through our Pharmacy Partnership Program, jointly delivering a compelling suite of services for physicians (Practice Support Program - hyperlink this to the description) that minimizes practice overhead while maximizing patient satisfaction.
For best results when printing this announcement, please click on the link below: http://pdf.reuters.com/pdfnews/pdfnews.asp?i=43059c3bf0e37541&u=urn:newsml:reuters.com:20130213:nPnDA59854 Lets technicians and pharmacists work together without pharmacists gowning-up and entering the restricted area or technicians interrupting their work to wait for, or seek out, their supervising pharmacists ALPINE, Texas, Feb. 13, 2013 /PRNewswire/ -- Envision Telepharmacy, LLC, a pioneer in remote pharmacy technology and services, announced today that the US Patent and Trademark Office has issued US Patent 8,374,887 covering the remote supervision and verification of sterile compounding by non-pharmacists in hospital and health care system settings. The patented method covers images or videos of the compounding process at appropriate stages, review by remotely-located pharmacists, and an indication of pharmacist verification. To reduce the cost of high-risk compounding in restricted areas, Envision incorporated this patent into its Pharm-Q In the Hood (ITH) product. Pharm-Q ITH lets technicians and pharmacists work together without pharmacists gowning-up and entering the restricted area or technicians interrupting their work to wait for, or seek out, their supervising pharmacists. "The recent 2012 public health crisis tied to the New England Compounding Center (NECC) began to highlight systemic problems in sterile product compounding, and has underscored the importance of the both the methods of preparation used and accountability for process," said inventor and Envision CEO Emily Alexander, PharmD., BCPS. "Increasing use of outsourced sterile products has, in part, been an attempt to manage drug shortages and provide patient-driven health care. The need for sterile compounded products will continue to increase as pharmaceutical companies continue to abandon drug production in response to declining margins. With increased oversight by state and federal agencies, the cost of producing sterile products will only rise. "This makes for the perfect storm, driving all healthcare institutions to re-visit the economics and risks associated with compounded injectable preparations. While safeguarding patients, our proprietary technology can help take the bite out of a costly but indispensable workflow element - pharmacist oversight and verification. Our method allows best utilization of pharmacists and pharmacy technicians by allowing them to focus on the parts of the process that most need their specialized training and skills. It also provides better process documentation, an area where increased scrutiny from regulators and accrediting agencies is already underway." The recently assigned patent was licensed exclusively to Envision Telepharmacy, becoming part of Envision's ever-expanding technology portfolio. Since its inception nearly 10 years ago, Envision has made significant investments in technologies that generate real returns to hospitals and health care institutions while meeting increasingly complex medication preparation requirements. About Envision Telepharmacy, LLC Envision Telepharmacy was established in 2004 to provide better ways to extend pharmacy services for hospitals and health care systems in need. We are a pioneer in developing tools, services and systems that provide electronic supervision and remote order processing through high-bandwidth, standards-based web technology, still imaging, and high resolution video. Enabling and realizing safe, quality patient care and pharmacist access through the use of compliant and cost-effective telepharmacy solutions is our mission. For more information about Envision Telepharmacy, LLC visit www.envision-rx.com or contact CEO Emily Alexander, PharmD, BCPS at (432) 897-0754 ext 105 or email envision(at)envision-rx(dot)com. SOURCE Envision Telepharmacy, LLC
Department of Health and Human Services | Public Health Service Food and Drug Administration |
Dallas District 4040 North Central Expressway Dallas, Texas 75204-3128 |
During our February 15 to March 7, 2012 inspection of your pharmaceutical manufacturing facility located at 1200 Paco Way, Lakewood , NJ, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug product, Santyl Ointment, to be adulterated within the meaning of section 501 (a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351 (a)(2)(8)], in that the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
We have reviewed your firm 's response of March 22, 2012, and note that it lacks sufficient corrective actions.To read the remainder of this warning letter, click here.