Senate HELP Committee Releases Draft Discussion Bill on Pharmacy Compounding
April 29, 2013
Staff from the Senate Health, Education, Labor, and Pensions (HELP) Committee hosted a briefing on Capitol Hill April 26 where they revealed a discussion draft  of a bill intended to help improve the safety of compounded human and animal drugs by making clear the oversight responsibilities of state and federal authorities. The discussion draft delineates between "traditional compounders" and "compounding manufacturers." Operations that meet the definition of "compounding manufacturer" would not be allowed to hold a state pharmacy license, would be subject to complete federal oversight authority under the Food and Drug Administration (FDA) and would have to meet Good Manufacturing Practices (GMP) standards. Compounding manufacturers would also be subject to specific labeling and reporting requirements, and annual FDA registration and fees. If you have comments or feedback on this discussion draft, send an email to email@example.com .
Hamburg Testifies Before the House on FDA Authority Over Compounding
April 17, 2013
Food and Drug Administration (FDA) Commissioner Margaret Hamburg testified April 16 before the House Subcommittee on Oversight and Investigations on the agency's authority to regulate specialty pharmacies engaged in sterile compounding. Hamburg stated that legislation is needed to clarify FDA's authority in order oversee firms similar to the New England Compounding Center (NECC), which was responsible for the October 2012 meningitis outbreak from contaminated compounded sterile drugs. Prior to the hearing, several Democratic members of the committee requested testimony from the International Academy of Compounding Pharmacists (IACP) to address concerns over IACP's lobbying activities in the years leading up to the meningitis outbreak. However committee chairman Tim Murphy (D-PA) declined to include IACP on the witness panel. For more information about the proceedings, read the article taken from TheHill.com .
Compounding Pharmacy Updates As 2013 Takes Hold
February 1, 2013
On January 1st, Massachusetts Governor Deval Patrick issued proposed new laws that would increase compounding pharmacy licensing requirements for Massachusetts Pharmacists, impose fines for lawbreakers, protect whistleblowers, and ensure licensing boards are free from bias. Read more on this story from the New York Times here. Meetings are also taking place among pharmacy and government stakeholders to ensure proper enforcement of current regulations. The FDA held a meeting on December 19th to inform stakeholders of the results of an intergovernmental meeting held earlier in the day to provide State officials the opportunity to discuss a variety of issues related to roles of the FDA and States in the oversight of compounding.
Congresswoman Rosa DeLauro (D-CT) and Congressman Edward Markey (D-MA) both introduced legislation during the last Congressional session in an effort to address compounding pharmacy safety concerns. The language in both of these bills is being negotiated with stakeholders and may be reintroduced soon. The Supporting Access to Formulated and Effective (SAFE) Compounded Drugs Act (H.R. 6638), introduced by Congresswoman DeLauro on December 5th, would enhance patient notification requirements, provide training for enforcement agencies, create temporary advisory committees under the Department of Health and Human Services (HHS) on labeling and databases, and create a permanent HHS advisory committee on pharmacy compounding. It would also require FDA to develop minimum standards for pharmacy compounding. The Verifying Authority and Legality In Drug (VALID) Compounding Act of 2012 (H.R. 6584) introduced by Congressman Markey on November 22nd, would amend the Federal Food, Drug, and Cosmetic Act to prohibit compounding pharmacies from dispensing a compounded drug prior to receipt of a valid order. It would also prohibit pharmacies from copying a commercially available drug.
Inside Health Policy outlined events in the House and Senate meningitis outbreak hearings
November 15, 2012
Inside Health Policy released an article November 15 outlining events in the House and Senate meningitis outbreak hearings. David Miller of IACP agreed on behalf of the pharmacy stakeholder community to work with lawmakers on new legislation for compounding in response to concerns over perceived resistance from the industry in 2007. Miller took issue with FDA's tiered approach, pointing to FDA's existing authority to regulate illegal drug manufacturers. Senator Alexander suggested the Senate will hold off on compounding legislation, to clarify FDA regulatory authority, until the beginning of next year while Congressman Henry Waxman urged the House to take immediate action. The full article is available to subscribers .
Congressional Hearings Investigating Meningitis Outbreak Held
November 15, 2012
Two Congressional hearings were held in the wake of the meningitis outbreak. The House Energy and Commerce Committee's Oversight and Investigations Subcommittee hosted "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"  November 14. Testimony from FDA, the Massachusetts Department of Health, and the wife of a victim of the meningitis outbreak was delivered to the committee. Co-owner and pharmacy director of the New England Compounding Center (NECC), Barry Cadden, was served a subpoena to appear before the committee, but he declined to respond to committee members' questions citing his fifth amendment rights.
The Senate Health, Education, Labor & Pensions Committee (HELP) hosted "Pharmacy Compounding: Implications for the 2012 Meningitis Outbreak,"  November 15. Testimony was heard from FDA, CDC, and the Massachusetts Department of Health and the Tennessee Department of Health. Barry Cadden of NECC was invited to answer questions from the committee, but he declined to appear. David G. Miller, Executive Vice President and CEO of the International Academy of Compounding Pharmacy, and Dr. Kasey Thompson, Vice President of Policy, Planning and Communications for the American Society of Health-System Pharmacists delivered expert witness testimony from the pharmacy prospective.
Copies of testimony and opening statements, as well as recordings of these proceedings are available at each of the committee's Web sites.
FDA to Congress: Fungal meningitis could happen again
November 15, 2012
Read the article taken from NBCNews.com . (PDF)
Pharmacy Organizations Issue Joint Statement in Response to Meningitis Outbreak
November 13, 2012
Read the joint statement  (PDF) issued by several pharmacy profession organizations, including ASCP, in response to the meningitis outbreak.
Ameridose Voluntarily Recalls All Unexpired Products
October 31, 2012
FDA announced  the voluntary recall of all unexpired products produced and distributed by Ameridose. FDA cites problems observed with sterility in Ameridose's production of injectible products that could lead to injury or death. A complete list of the products subject to the recall can be found at Ameridose.com .
Numerous Lawsuits Anticipated in Meningitis Outbreak
October 20, 2012
Legal specialists anticipate a “flood of lawsuits”  as the impact of a meningitis outbreak unfolds. As of October 19, cases have already been filed in Florida, Massachusetts, Michigan, Minnesota, New Jersey, Tennessee, and Virginia, including some class-action suits. While the bulk of cases are likely to be filed against the New England Compounding Center, the pharmacy at the center of the meningitis outbreak, some lawsuits are also targeting clinics who administered the contaminated steroid injections to patients.
Meningitis at Root of Outbreak a Relative Unknown
October 20, 2012
The fungal meningitis that so far has killed over 20 patients and sickened over 200 is relatively unknown to researchers and health experts, according to an October 20 report . Fungal brain infections, which are slow to develop and frequently deadly, are generally rare in the healthy population. In addition, the particular fungus involved in the current outbreak is difficult to treat because of a chemical similarity to human cells.
Calls for Congress to Address Compounding
October 19, 2012
In the wake of a meningitis outbreak from contaminated compounded injections, stakeholders are calling on Congress  (subscription required) to require pharmacies to report adverse events to FDA. Reps. Ed Markey (D-MA) and Rosa DeLauro (D-CT) are considering legislation that would, in addition to reporting requirements, require pharmacies to warn their patients that compounded medication has not been reviewed by FDA. The potential bills also may create clearer statutory distinctions between compounding and manufacturing.
MedWatch alert from FDA
October 16, 2012
CDC and FDA have confirmed the presence of a fungus known as Exserohilum rostratum in unopened medication vials of preservative-free methylprednisolone acetate (80mg/ml) from one of the three implicated lots from NECC (Lot #08102012@51, BUD 2/6/2013). The laboratory confirmation further links steroid injections from these lots from NECC to the multistate outbreak of fungal meningitis and joint infections. Testing on the other two implicated lots of methylprednisolone acetate and other NECC injectables continues.
CDC and state health departments estimate that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.
There is now available a Patient Notification Letter  on the FDA "Update on Fungal Meningitis" webpage under the "Related Information" section. This letter template is for health care professionals notifying patients administered a drug produced by the New England Compounding Center (NECC) that has been recalled.
MedWatch alert from FDA
October 15, 2012
The Food and Drug Administration (FDA) issued an October 15th MedWatch Safety alert informing the public and health care professionals of the ongoing meningitis outbreak associated with injectable products distributed by the New England Compounding Center (NECC). The FDA advises health care professionals to follow-up with patients who were administered any injectable medication from or produced by NECC, including injectable ophthalmic drugs used in conjunction with eye surgery, or a cardioplegic solution purchased from or produced by NECC after May 21, 2012.
The FDA also issued a statement alerting health care professionals to two new suspect products (triamcinolone acetonide and cardioplegic solution). The Administration has asked to be notified of any adverse drug reports linked to NECC products through their Medwatch online reporting system . Updated recommendations for patients and health care professionals, as well as, a current list of NECC injectable products can also be found in the alert and statement.
Currently, there are hundreds of documented cases and multiple deaths associated with NECC products. The CDC web page is updated with current information on the outbreak and the CDC investigation.