News tagged compounding
DEA Guidance Regarding Information Pharmacists May Provide on CS II Prescriptions
Recognizing that pharmacists are sometimes presented with prescriptions for Schedule II controlled substances that are missing information required by law, Drug Enforcement Administration provides guidance for pharmacists regarding allowed changes or additions to such prescriptions.
Read More →Nominations for 2014 NABP Annual Awards Now Being Accepted
NABP invites you to nominate a colleague or board of pharmacy for a 2014 NABP award.
Read More →FDA Provides New Information About Lack of Sterility Assurance for Drugs Dispensed by The Compounding Shop
Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution (for nasal irrigation), dispensed by The Compounding Shop of St Petersburg, FL, may be contaminated and should not be used or administered to patients.
Read More →Michigan Lawmakers Consider Bill to Strengthen Compounding Regulations
A series of bills have been introduced to the Michigan Legislature that would include several provisions intended to strengthen the regulation of compounding in the state.
Read More →University Compounding Pharmacy Recalls Some Products Due to Lack of Sterility Assurance
Food and Drug Administration (FDA) and University Compounding Pharmacy of San Diego, CA, have issued a voluntary recall of several products.
Read More →Park Pharmacy & Compounding Center Recalls Two Compounded Sterile Preparations
Food and Drug Administration (FDA) and Park Pharmacy & Compounding Center of Irvine, CA, have announced a voluntary recall of two lots of products that were dispensed to patients and distributed to physician offices by prescription in June and July 2013 in California, Florida, New Mexico, and Indiana.
Amid Continuing Inspections, Two Massachusetts Compounding Pharmacies Closed
Medi-Son Solutions of Norwood, MA, and its sister company, CarePro, in Quincy, MA, have been closed at the order of the Massachusetts Board of Registration in Pharmacy.
Read More →Specialty Compounding, LLC, Clarifies Recall Information
Specialty Compounding, LLC, clarified a recall of all lots of sterile compounded medications produced in its Texas facility.
Specialty Compounding, LLC Recalls All Lots of Unexpired Sterile Products After Reports of Adverse Events
Food and Drug Administration (FDA) has announced a voluntary recall of all lots of unexpired sterile products produced by Specialty Compounding, LLC, in Cedar Park, TX.
GAO Issues Recommendations for Congress and the Secretary of Health and Human Services for Compounding Pharmacies
In a July 2013 report, the United States Government Accountability Office (GAO) recommends that “Congress should consider clarifying FDA’s authority to oversee certain entities that compound drugs.”
Domperidone Not FDA Approved, Should Not be Marketed in the US, FDA Stresses
Food and Drug Administration (FDA) stresses that domperidone is not an FDA-approved drug, and that it may not be legally marketed in the US.
NABP Delivers Testimony at House Subcommittee Hearing on Reforming Compounding Regulations
A United States House of Representatives subcommittee held a hearing July 16, 2013, to examine various bills aimed to implement new frameworks for the regulation of compounding.
Massachusetts House Considers Compounding Bill
Legislation intended to help ensure the safety of drugs compounded in Massachusetts is being considered by the state’s House of Representatives.
Consent Decree Prohibits New Jersey Pharmacy from Manufacturing, Distributing Drug Products
Med Prep Consulting, Inc, has been prohibited from manufacturing, holding, and distributing drug products under a consent decree of permanent injunction entered against the pharmacy by a federal court.
Tennessee Board of Pharmacy Implements Rule to Facilitate Earlier Responses to Compounding Safety Issues
The Tennessee Board of Pharmacy has implemented a new rule that will effectively enable the Board to act more quickly when a potential safety issue at a facility engaged in compounding is detected.
FDA Confirms Presence of Microbial Growth in Main Street Family Pharmacy Products
As a result of an investigation initiated in May 2013, FDA has identified bacterial and fungal growth in products compounded by Main Street Family Pharmacy of Newbern, TN.
Bills to Safeguard Medications Through National Tracking System Under Consideration in Congress
A bill aimed to ensure the security of pharmaceuticals in the drug supply chain has passed the United States House of Representatives.
Tennessee Pharmacy Voluntarily Recalls Sterile Compounded Products, FDA Works With State Regulators in Ongoing Investigation
Food and Drug Administration (FDA) has issued an alert warning against the use of sterile products compounded and dispensed by Main Street Family Pharmacy, LLC, of Newbern, TN.
Updated House Bill Would Require FDA to Regulate Pharmacies Involved in High-Risk Compounding and Interstate Commerce
United States Representative Edward Markey (D-MA) filed an updated version (PDF) of the Verifying Authority and Legality in Drug (VALID) Compounding Act of 2013 on May, 23, 2013.
NABP Testifies at US House Subcommittee Hearing Regarding Support for Federal Legislation to Distinguish Between Compounding and Manufacturing
NABP expressed its support for federal legislation that would distinguish between compounding and manufacturing, in testimony presented at a United States House subcommittee hearing on May 23, 2013.
NABP Expresses Support of Federal Legislation That Distinguishes Compounding From Manufacturing and Clarifies Regulatory Oversight
National Association of Boards of Pharmacy ® (NABP®) has expressed its support for the Pharmaceutical Compounding Quality and Accountability Act.
NABP Surveyors to Assist With New Jersey Compounding Pharmacy Inspections Under Contract With the State
Under a contract with the New Jersey Division of Consumer Affairs and the state’s Attorney General Jeffrey S. Chiesa, NABP will assist the Division with inspections of New Jersey pharmacies engaged in the practice of compounding.
New Missouri Law to Grant Board of Pharmacy Authority to Inspect Drugs in Inventory
The Missouri Board of Pharmacy will be allowed to test drugs in pharmacy inventories under a new law.
NABP Supports Federal Legislation Creating New Category of Manufacturer Under FDA Oversight, While Maintaining Board of Pharmacy Authority Over Compounding Pharmacies
In testimony presented at a United States Senate Committee Hearing, NABP expressed its support of draft legislation that would create a new category of manufacturer to include entities that engage in large-scale production of sterile non-patient-specific drugs for distribution.
Products Produced by The Compounding Shop Should Be Quarantined Due to Lack of Sterility Assurance, Warns FDA
Medications produced and distributed by The Compounding Shop of St Petersburg, FL, should not be administered to patients and should be quarantined, warns FDA.
US Senate Committee Proposes Legislation to Create Compounding Manufacturer Category to Be Under FDA Regulation
Federal lawmakers have drafted legislation that would create a new category of drug compounders, “compounding manufacturers,” to be regulated by Food and Drug Administration (FDA).
Two Compounding Pharmacies Recall Sterile Products Over Sterility Assurance Concerns
Two pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance.
Bill to Strengthen Regulation of Compounding Introduced in Maine Legislature
A bill to strengthen the regulation of compounding pharmacies in Maine was introduced to the state’s legislature.
House Committee Members Examine FDA’s Responsibilities Relative to the Meningitis Outbreak
In a meeting last week, members of a House Energy and Commerce subcommittee stressed that Food and Drug Administration (FDA) could have done more to prevent the fungal meningitis outbreak that killed 53 people and sickened hundreds in late 2012.
FDA Reports Unsanitary Conditions at Compounding Facilities, Calls for More Regulatory Authority
FDA Commissioner Margaret A. Hamburg, MD, reported in a recent FDA blog article that agency inspectors encountered “objectionable conditions” at 30 of the 31 sterile compounding pharmacies they recently examined.
Dallas Drug Makers Issue Voluntary Recall for Sterile Products
FDA is warning health care providers to quarantine and cease use of sterile drug products from ApotheCure, Inc, and NuVision Pharmacy, two Dallas, TX, facilities.
Tennessee Bill Would Allow Non-Patient-Specific Compounding During Drug Shortages
Tennessee lawmakers are considering legislation that would enable compounding pharmacies to create medicines without patient-specific prescriptions during drug shortages and other times when a product is not commercially available.
Congressional Report Highlights State Challenges in Regulating Compounding Pharmacies
A report released by US Representative Ed Markey (D-MA) highlights the challenges states face in regulating compounding pharmacies and examines how the pharmacies are tracked and inspected.
Nevada Pharmacy Recalls All Sterile Compounded Products
Nevada-based Green Valley Drugs has issued a voluntary recall of all lots of all its compounded, repackaged drugs because of a lack of sterility assurance.
Pallimed Recalls All Sterile Compounded Drugs Due to Presence of Particulates in Some Vials
To ensure patient safety, Pallimed Solutions, Inc, of Woburn, MA, has initiated a voluntary recall of all sterile compounded products dispensed since January 1, 2013.
FDA Calls for Legislation to Allow Federal Oversight of Entities Compounding Non-Patient-Specific Drugs
US Food and Drug Administration (FDA) has called for the development of legislation to establish appropriate, minimum federal standards for entities engaged in the compounding of non-patient-specific sterile drugs for interstate distribution, states FDA Commissioner Margaret Hamburg, MD.
States Take Action to Ensure Safety of Compounded Drugs
Through board of pharmacy inspections of compounding pharmacies and proposed laws to tighten requirements for compounding, states are taking action to help ensure the safety of compounded drugs.
New Jersey Compounding Pharmacy Recalls All Compounded Products Due to Mold Contamination
Med Prep Consulting, Inc, a New Jersey-based compounding pharmacy, voluntarily recalled all lots of all its compounded products after a Connecticut hospital discovered mold particles in five bags of an intravenous solution.
Georgia Compounding Pharmacy Recalls All Sterile Products After Eye Infections Reported
FDA is alerting health care providers and patients of a voluntary recall of all sterile products produced and distributed by Clinical Specialties Compounding Pharmacy (CSCP) of Augusta, GA.
Former NECC Employees Reveal Compounding Facility's Conditions During 60 Minutes Segment
Former New England Compounding Center (NECC) employees reveal how workload and facility conditions contributed to the tragic meningitis outbreak linked to the company’s contaminated drugs in a 60 Minutes segment.
FDA Continues Inspections of Facilities Compounding Sterile Injectable Drugs
Inspections of 30 entities engaged in compounding are underway by Food and Drug Administration (FDA) inspectors as part of the agency’s response to the 2012 meningitis outbreak linked to contaminated compounded injectable drugs.
Member Boards Move Swiftly to Implement NABP Compounding Action Plan and to Strengthen State Regulation of Compounding Pharmacies
NABP member boards of pharmacy are moving swiftly to implement the Compounding Action Plan initiated by state boards of pharmacy and NABP in November 2012.
California Bill Would Implement Stricter Requirements for Pharmacies Compounding Sterile Drugs
Pharmacies compounding sterile drug products for dispensing to patients in California would be required to obtain a license to engage in that practice under a bill introduced to the state’s senate on February 19, 2013.
Virginia Bill to Implement Stricter Inspection Requirements for Nonresident Compounding Pharmacies Under Consideration
Stricter inspection requirements for nonresident compounding pharmacies and a clarification that distinguishes compounding from manufacturing are among the statutory changes included in House Bill 2312 currently being considered by the Virginia Legislature.
FDA Reexamines Its Exercise of Enforcement Discretion Regarding Valid, Patient-Specific Prescriptions and Compounding Pharmacies
In a letter (PDF) to PharMEDium Services LLC, Food and Drug Administration (FDA) Center for Drug Evaluation and Research indicates that it will no longer exercise enforcement discretion that allowed the company to produce non-patient specific drug products for distribution to hospitals across the country.
Surprise Inspections in Massachusetts Result in Cease and Desist Orders to 11 Compounding Pharmacies
Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH).
ISMP Publishes Survey Results on Compounding Practices
A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed.
NABP Member Boards Take Action to Strengthen Regulation of Compounding Practice
With the multistate meningitis outbreak linked to unsafe compounding practices at the New England Compounding Center, multiple stakeholders, including NABP, are seeking to clarify the law and put in place new systems.
Tennessee Task Force Reviews State’s Compounding Pharmacy Regulations
The Tennessee Board of Pharmacy has convened a task force to review the state’s regulations pertaining to compounding and determine how regulations might be strengthened to further protect the public health.
Massachusetts Close to Completing Surprise Inspections of Compounding Pharmacies, FDA Joins Investigation of One Pharmacy
Bureau of Health Care Safety and Quality inspectors in Massachusetts are close to completing a round of surprise inspections of compounding pharmacies and FDA inspectors have also begun inspecting one of the pharmacies.
Texas Board Surveys Pharmacies About Compounding Practices, Will Seek Legislative Support for Additional Inspectors
In the wake of the meningitis outbreak linked to contaminated drugs compounded by the New England Compounding Center (NECC), the Texas State Board of Pharmacy conducted a special survey.
Minnesota Board Implements Plan to Strengthen Regulation of Compounding Pharmacies
The Minnesota Board of Pharmacy, which already has strong compounding regulations and requirements in place, is in the process of considering additional requirements, some of which will require the passage of new legislation.
California Board of Pharmacy Sponsors Legislation Authorizing Inspection of Nonresident Compounding Pharmacies
The California State Board of Pharmacy will sponsor a bill that would allow inspectors to make unannounced on-site inspections of certain nonresident pharmacies.
Massachusetts Governor Patrick Files Bill to Strengthen State’s Regulation of Compounding Pharmacies
Massachusetts Governor Deval Patrick will file a bill that would strengthen the state’s regulation of compounding pharmacies.
Florida Board of Pharmacy Calls for Permits for Drug Compounders
In an effort to improve oversight of compounding pharmacies in the state, the Florida Board of Pharmacy formed a committee of its colleagues to create a series of permits.
House Bill Would Tighten Federal Regulations of Compounding Pharmacies
In an attempt to tighten federal oversight of compounding pharmacies in the wake of the meningitis outbreak, the S.A.F.E. Compounded Drugs Act of 2012 (HR 6638) was introduced in Congress.
Massachusetts Board of Registration in Pharmacy Works to Fortify Compounding Regulations
The Massachusetts Board of Registration in Pharmacy is considering eight potential solutions for improving the state’s regulation of pharmacy compounding. The solutions are part of the Board’s efforts to streamline compounding rules and improve patient safety.
NECC and Ameridose Closures Intensify Drug Shortages
Hospitals and medical centers that relied upon the NECC and its sister company, Ameridose LLC, are suffering shortages of antibiotics, pain medications, and other drugs.
NABP Leads the Charge as States Tighten Ranks Around Compounding Pharmacies
Supporting state board of pharmacy efforts to enforce compounding regulations, the National Association of Boards of Pharmacy® (NABP®) is implementing a four-part action plan centered around inspection of nonresident compounding pharmacies and creating an information sharing network of regulatory details...
Read More →Safe Compounding Resources Provided On USP Web Site
In an effort to facilitate the delivery of good-quality medicines, United States Pharmacopeial Convention (USP) provides information about compounding and the role of USP standards for practitioners, patients, associations, and regulatory bodies on the USP Compounding Standards & Resources page...
Read More →Congressional Committee Holds Hearing to Investigate Causes of Fungal Meningitis Outbreak
The United States House of Representatives Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations held a hearing today, November 14, 2012, to hear testimony regarding the multi-state outbreak of fungal meningitis that has been linked to contaminated methylprednisolone...
Read More →ASHP Offers Provider Resources on Safe Compounding and Outsourcing
The American Society of Health-System Pharmacists (ASHP) provides several resources to help pharmacists and other providers address the new responsibilities and demands resulting from the fungal meningitis outbreak caused by contaminated methylprednisolone acetate injection compounded by NECC. The ASHP Sterile...
Read More →Legislation to Strengthen Compounding Regulations Introduced to Congress
Legislation that would give Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country was introduced to Congress on November 2, 2012, by Representative Edward J. Markey (D-MA). The Verifying Authority and Legality In...
Read More →MA Board of Pharmacy Approves Emergency Regulations for Compounding Pharmacies
The Massachusetts Board of Registration in Pharmacy has approved emergency regulations to enhance oversight of compounding pharmacies. The emergency regulations (PDF) will allow the state to track volume and distribution at compounding pharmacies in order to determine if a pharmacy...
Read More →Additional NECC Products Test Positive for Bacterial Contamination, FDA Reports
FDA and Centers for Disease Control and Prevention (CDC) report that samples of two additional recalled New England Compounding Center (NECC) products, preservative-free injectable betamethasone and cardioplegia solution, have tested positive for bacteria. Previously, the fungus Exserohilum rostratum was identified...
Read More →All Ameridose Drug Products Recalled, FDA Reports
FDA announced that Ameridose, LLC, voluntarily recalled all of its unexpired drug products on October 31, 2012. Ameridose, based in Westborough, MA, initiated the recall in response to findings from an FDA inspection that raised concerns about lack of sterility...
Read More →CDC and FDA Continue Investigation as Number of Fungal Meningitis Cases Climbs
As the investigation continues into the multistate outbreak of meningitis due to contaminated methylprednisolone injections compounded by the New England Compounding Center (NECC), Centers for Disease Control and Prevention (CDC) reports that at least 363 individuals have been affected. Further,...
Read More →CDC and FDA Provide Updates on Meningitis Outbreak and Related Investigation
Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) have confirmed that the contaminated intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC) are linked to the multistate outbreak of fungal meningitis and joint...
Read More →Outbreak of Meningitis Associated With Contaminated Intrathecal Steroid Injection
At least 231 cases of fungal meningitis, including 15 deaths, have been reported to be caused by intrathecal methylprednisolone injections compounded by the New England Compounding Center (NECC). Of the 231 cases reported as of October 16, 2012, a total...
Read More →Compliance Study on Sterile Compounding Practices Calls for Participants
Sterile compounding facilities are invited to participate in the 2012 USP <797> Compliance Study, a National Study of Sterile Compounding Practices, co-directed by sterile compounding experts, Eric Kastango, RPh, MBA, FASHP, and Kate Douglass, MS, RN, APN,C, CRNI. The study...
Read More →Regulatory Authority Over Compounding Pharmacies Resides with Boards of Pharmacy, Federal Judge Holds
In the case of US v Franck's Lab, Inc, US District Court for the Middle District of Florida has ruled that FDA does not have jurisdictional authority over the compounding of medications by a licensed pharmacy as long as the...
Read More →ISMP Calls for Action In Response to Infections Caused By Contaminated TPN; NABP Helps Educate Boards
In response to the infections of 19 Alabama patients by contaminated total parenteral nutrition (TPN), the Institute for Safe Medication Practices (ISMP) has called upon Food and Drug Administration (FDA) to take several actions, including collaborating with boards of pharmacy...
Read More →Safe Practice Guidelines for PN Compounding Available from ASPEN
In response to the deaths of nine patients in Alabama hospitals who were infected with contaminated parenteral nutrition, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued a statement reminding practitioners of the availability of its complimentary publications providing...
Read More →FDA Reminder About Emergency Compounding of Tamiflu for Oral Suspension
The FDA has added Tamiflu® for Oral Suspension 12 mg/ml 25 ml (National Drug Code 00004-0810-95) to its current list of drug shortages, and reminds health care providers about instructions for emergency compounding of Tamiflu 75 mg capsules. While FDA...
Read More →FDA Seeks Injunction Against Florida Animal Drug Compounder
Food and Drug Administration (FDA) is seeking an injunction in federal court against Franck’s Compounding Lab of Ocala, FL, to prevent the company from introducing adulterated, misbranded, and unsafe animal drugs into interstate commerce, as reported in an FDA News...
Read More →Missouri News: Compounded Drug Testing Report for Fiscal Year 2008
Published in the May 2009 Missouri Board of Pharmacy Newsletter As part of a program initiated in 2003, the Board continues to test drug preparations compounded by pharmacies. Preparations are collected by inspectors and sent to certified laboratories for potency...
Read More →Oregon News: Oregon's First Accredited Compounding Pharmacy
Published in the February 2009 Oregon State Board of Pharmacy Newsletter The Pharmacy Compounding Accreditation Board (PCAB) notified the Board of Pharmacy that it has provided accreditation status to Broadway Apothecary, located at 1712 Willamette Street in Eugene. The pharmacy...
Read More →North Carolina News: Item 2160 - Compounding OTC Products
Reprinted from the April 2008 North Carolina Board of Pharmacy Newsletter. North Carolina Board of Pharmacy staff periodically receives questions about the compounding of over-the-counter (OTC) products. Compounding of OTC products can involve at least two scenarios. First, a pharmacist...
Read More →Kentucky News: Revisions to USP Chapter 797 (Sterile Compounding)
Published in the March 2008 Kentucky Board of Pharmacy Newsletter After nearly thirty (30) months in revision, United States Pharmacopeia (USP) posted the final update for USP General Chapter 797, “Pharmaceutical Compounding – Sterile Preparations.” Information for obtaining a copy of...
Read More →Missouri News: Compounded Drug Testing Report for Fiscal Year 2007
Published in the February 2008 Missouri Board of Pharmacy Newsletter As part of a program initiated in 2003, the Board continues to test drug preparations compounded by pharmacies. Inspectors collect prepa¬rations and send them to certified laboratories for potency testing...
Read More →Minnesota News: Adoption of Rules Package
Reprinted from the October 2007 Minnesota Board of Pharmacy Newsletter. On May 14, 2007, a notice of “Adopted Permanent Rules Relating to Pharmacy Regulations” was published in the Minnesota State Register. This was the final step in the adoption of...
Read More →North Carolina News: Item 2140 - Compounding Issues
Reprinted from the July 2007 North Carolina Board of Pharmacy Newsletter. North Carolina Board of Pharmacy staff members are aware that several pharmacies, both in-state and out-of-state, regularly engage in the compounding of prescription veterinary drug products for resale. This...
Read More →Missouri News: Compounded Drug Testing Report
Published in the February 2007 Missouri Board of Pharmacy Newsletter In 2003, the Board initiated a program to test drug preparations compounded by pharmacies. All preparations are tested for potency and, if applicable, sterility and endotoxin. The tables below are...
Read More →South Dakota News: Compounding or Manufacturing
Published in the July 2006 South Dakota State Board of Pharmacy Newsletter The question of whether a practice is compounding or manufacturing is best answered by whether or not you are preparing a medication pursuant to a legal prescription for...
Read More →Missouri News: Compounding Issues
Published in the May 2006 Missouri Board of Pharmacy Newsletter 4 CSR 220-2.400(9) prohibits the compounding of drugs that are essentially copies of commercially available products. There must be sufficient documentation within the prescription record of a specific medical need...
Read More →Washington News: Drug Compounding
Published in the April 2006 Washington State Board of Pharmacy Newsletter We receive many calls about pharmaceutical compounding practices. One recent call related to the appropriateness of compounding L-tryptophan capsules for human use. According to Food and Drug Administration (FDA),...
Read More →Ohio News: New and Revised Rules Have Been Filed
Published in the February 2006 Ohio State Board of Pharmacy Newsletter The Board filed several new and revised rules that became effective on January 1, 2006. The full text of these rules, showing changes, can be found on the Board’s...
Read More →North Carolina News: Item 2104 - New Labeling Law
Reprinted from the January 2006 North Carolina Board of Pharmacy Newsletter. This is another reminder that beginning in January 2006 Board rules now require the generic name of the product on the label even if no generic product is available....
Read More →Oklahoma News: Committee Volunteers Needed
Published in the January 2006 Oklahoma State Board of Pharmacy Newsletter The Board needs volunteers for upcoming committee work. We will have two (2) working committees starting in 2006: Compounding Rules Committee (United States Pharmacopeia Chapter 797) and Wholesale Pedigree...
Read More →2005-2006 Report of the Task Force on Standards for Compounding
The Task Force on Standards for Compounding met on November 11, 2005. Task force members reviewed their charge and accepted it as follows: This Task Force is charged with reviewing standards set forth in USP Chapter 795, “Pharmaceutical Compounding–Nonsterile Preparations,”...
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