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 pharmacies have voluntarily recalled their sterile compounded products because of concerns associated with quality control processes and a lack of sterility assurance. 

A bill to strengthen the regulation of compounding pharmacies in Maine was introduced to the state’s legislature.

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 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.

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 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.

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-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. 

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. 

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.

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.

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.

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 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.

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.

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.

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.

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. 

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. 

Partial or complete cease and desist orders were issued to 11 compounding pharmacies by the Massachusetts Department of Public Health (DPH).

A majority of respondents to a survey on compounding practices indicated that pharmacy technicians who work in sterile compounding should be certified or licensed. 

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. 

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. 

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.

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.

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. 

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 Deval Patrick will file a bill that would strengthen the state’s regulation of compounding pharmacies. 

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.

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.

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.

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.

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...

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...

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...

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...

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...

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...

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...

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...

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,...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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),...

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...

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....

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...

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,”...