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Saturday, November 22, 2014

Question relating to compounding pharmacy non compete agreement shows how some states disfavor and do not enforce these agreements

Pharmacist signed non-compete agreement due to working for compounding pharmacy. Can he engage in cosmetics compounding?

More Guidance from FDA on Outsourcing Facilities making compounded medications to be published November 24, 2014 in Federal Register


  • Federal Register, Volume 79 Issue 226 (Monday, November 24, 2014)

    www.gpo.gov/fdsys/pkg/FR-2014-11-24/html/2014-27691.htm
    3 hours ago - FDA-2013-N-1428] Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance AGENCY: Food and DrugAdministration, ...
  • Federal Register, Volume 79 Issue 226 (Monday, November 24, 2014)

    www.gpo.gov/fdsys/pkg/FR-2014-11-24/html/2014-27693.htm
    3 hours ago - FDA-2013-N-1429] Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Final Guidance for Industry; ...
  • Federal Register, Volume 79 Issue 226 (Monday, November 24, 2014)

    www.gpo.gov/fdsys/pkg/FR-2014-11-24/html/2014-27692.htm
    3 hours ago - FDA-2014-D-0329] Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act; Guidance for Industry; Availability AGENCY: Food and Drug ...
  • NH Board of Pharmacy to Hold Work Sessions on Rules

    Work Session On Rules
     The Board will be holding a work session on its Ph 300 Adobe Acrobat symbolrules (Licensing Regulations for Pharmacists, In-State Pharmacies, and Prescription Drug / Device Manufacturers / Wholesalers / Distributors) on Friday, November 21, 2014 at 2:30 P.M. at the Board Office (Philbrook Building, 121 South Fruit Street, Concord, NH - Conference Room 126. The public is welcome to attend but seating is extremely limited - please email the Board if you plan on attending. This is the beginning of rules planning for this section of the Board's rules and no proposed changes have been submitted yet..
     Work Session On Rules
     The Board will be holding a work session on its Ph 700 Adobe Acrobat symbol(Standards of Practice) rules on Tuesday, November 25, 2014 at 3:30 P.M. at the Board Office (Philbrook Building, 121 South Fruit Street, Concord, NH - Conference Room 116. The public is welcome to attend. This is the beginning of rules planning for this section of the Board's rules and no proposed changes have been submitted yet.

    Friday, November 21, 2014

    FDA Regulatory Requirements, Enforcement Activity Have Increased Despite Agency Acknowledging the Strain on Small Companies

    FDA Regulatory Requirements, Enforcement Activity Have Increased Despite Agency Acknowledging the Strain on Small Companies

    Japan Pharmaceutical Companies Release Their Own

    Japan Pharmaceutical Companies Release Their Own

    Physician Payments Sunshine Act: Top Michigan Doctors Provide Context To Their Payments

    Physician Payments Sunshine Act: Top Michigan Doctors Provide Context To Their Payments

    University of Maryland Health Law Regulatory & Compliance Competition Will Be Held February 21, 2015, Registration Due December 12, 2014

    University of Maryland Health Law Regulatory & Compliance Competition Will Be Held February 21, 2015, Registration Due December 12, 2014

    NIH Issues Clinical Trial Transparency Proposal; Expands Submissions to Results From Unapproved Products, Requires Detailed Adverse Event Information

    NIH Issues Clinical Trial Transparency Proposal; Expands Submissions to Results From Unapproved Products, Requires Detailed Adverse Event Information

    Concerned groups call for stronger measures vs counterfeit medicine

    Concerned groups call for stronger measures vs counterfeit medicine

    Guidance issued by FDA on compounding outsourcing facilities


    Today, the U.S. Food and Drug Administration issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the Drug Quality and Security Act (DQSA), which was enacted in November 2013.