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
Friday, January 31, 2014
Question of the Day January 31, 2014 What are compounding pharmacies that do both human and veterinary compounding doing to comply with DQSA? How can they comply with both the outsourcing provision for human compounds but still comply on the veterinary side? Is this an unintended consequences of the DQSA forcing compounding pharmacies that do both to either incur more expense or decide whether they will compound human drugs (as outsourcing facilities) or veterinary drugs in compliance with traditional compounding? Doesn't this suggest Congress needs to take immediate action regarding veterinary compounding and resolve the conflict?
Private Equity Firm Clayton, Dubilier & Rice Completes PharMEDium Deal
Clayton, Dubilier & Rice announced the close of an investment in PharMEDium Healthcare Corporation, the leading national provider of hospital pharmacy-outsourced sterile compounding services. Terms of the transaction were not disclosed.PharMEDium’s outsourced sterile compounding services are used by hospitals primarily to facilitate ready-to-use intravenous drug therapy to patients; it is one of the first companies to voluntarily register with the U.S. Food and Drug Administration’s (FDA) as an Outsourcing Facility and to comply with guidelines under the newly created section 503B of the Drug Quality and Security Act. Using only FDA-approved drugs, diluents and containers, the Company creates compounded sterile preparations, which are not otherwise commercially available in the marketplace. PharMEDium provides CSPs in ready-to-use presentation with enhanced safety, labeling, sterility and shelf life, typically exceeding what hospital pharmacies can produce themselves. The Company’s CSPs are primarily used in: (i) intravenous pain management and anesthesia associated with surgical procedures and post-operative care, (ii) the intensive care unit (CSPs including analgesics, antibiotics, anticoagulants and electrolytes), and (iii) labor and delivery (epidurals and oxytocin).Based in Lake Forest, Illinois, PharMEDium serves more than 2,600 acute-care hospitals, including integrated delivery systems, academic medical centers, hospital groups, and standalone urban, suburban and rural hospitals.About Clayton, Dubilier & RiceFounded in 1978, Clayton, Dubilier & Rice is a private equity firm with an investment strategy predicated on producing financial returns through building stronger, more profitable businesses. Since inception, CD&R has managed the investment of $19 billion in 59 businesses representing a broad range of industries with an aggregate transaction value of approximately $90 billion. The Firm has offices in New York and London. For more information, please visit www.cdr-inc.com. - See more at: http://newyork.citybizlist.com/article/clayton-dubilier-rice-completes-pharmedium-deal#sthash.MyEnEZkX.dpuf
Inside Health Reform: In First DQSA Warning Letters, FDA Targets Compounders Without Patient Prescriptions
In First DQSA Warning Letters, FDA Targets Compounders Without Patient Prescriptions (Daily News - 01-30-2014)
FDA issued two warning letters to drug compounders in recent weeks chastising them for lacking patient-specific prescriptions -- the first letters citing the recently passed Drug Quality and Security Act and delving into a point of conflict between state and federal laws.
FDA Law Blog January 30, 2014 An Old Fashioned Park Criminal Prosecution With Some Twists - Part II
By John R. Fleder –
On October 2, 2013, HP&M posted the following on this blog:
On October 2, 2013, HP&M posted the following on this blog:
On September 26, 2013, the United States Attorney for the District of Colorado announced that he had filed a six count criminal Information against Eric and Ryan Jensen. The government alleges that the defendants violated the FDC Act by introducing adulterated cantaloupes into interstate commerce. The government also alleges that the cantaloupes bore Listeria monocytogenes and 33 people died. It is quite curious (we are being charitable here) that the government’s press release alleges that 147 people were hospitalized as a result of sales of the cantaloupes, but those allegations appear nowhere in the criminal Information!continue to read here
FDA Law Blog January 30, 2014 Speech by High-Level DOJ Official Claims Shared Interests of Prosecutors and Regulated Industry
By JP Ellison –
In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with industry’s interests. While the speech didn’t break any new ground, it serves as a reminder that pharmaceutical enforcement cases remain a DOJ priority and suggests that recent enforcement trends will continue.
AAG Delery Claimed that DOJ and industry shared the following:
In a speech on January 29th at the CBI Pharmaceutical Compliance Congress that DOJ posted on its own website, U.S. Department of Justice Assistant Attorney General Stuart Delery set forth his views of the three ways that the government’s enforcement interests align with industry’s interests. While the speech didn’t break any new ground, it serves as a reminder that pharmaceutical enforcement cases remain a DOJ priority and suggests that recent enforcement trends will continue.
AAG Delery Claimed that DOJ and industry shared the following:
- “[A] common interest in promoting ethical corporate culture instead of maintaining a compliance program in name only;”
- “Transparency about the conduct [the government] investigate[s];” and
- “[A] common interest in ensuring that corporate compliance is not only the right thing to do but also a winning business strategy.”
Thursday, January 30, 2014
New York issues summary suspension against Rockwell Compounding Associates Inc.
. SUMMARY SUSPENSIONS
Rockwell Compounding Associates, Inc.; Pharmacy; 350 Theodore Fremd Avenue, Rye, NY 10580; Reg. No. 026458; Cal. No. 27163; Application for summary suspension granted.
quoted from here
Pharmacy
Steven J. Cosentino; Pharmacist; Rye, NY 10580; Lic. No. 031570; Cal. No. 27162; Application for summary suspension granted.Rockwell Compounding Associates, Inc.; Pharmacy; 350 Theodore Fremd Avenue, Rye, NY 10580; Reg. No. 026458; Cal. No. 27163; Application for summary suspension granted.
quoted from here
New England Compounding Pharmacy, Inc. Bankruptcy New Filing Alert: Motion For Relief From The Automatic Stay
On January 29, 2014, a motion for relief from the automatic stay was filed in the bankruptcy case of New England Compounding Pharmacy, Inc. and its affiliates. The filing was assigned docket number 663 and is described on the court’s official docket as follows:
Motion filed by Plaintiffs Irene and Joseph Phillips, Norma Montague, Ronald and Tammy Driscoll for Relief from Stay Re: Fee Amount $176, Objections due by 02/12/2014. (Attachments: # (1) Exhibit Memorandum in Support of Motion for Limited Relief From Stay on Behalf of Movants) (Gonzalez, Ervin)
quoted here
Motion filed by Plaintiffs Irene and Joseph Phillips, Norma Montague, Ronald and Tammy Driscoll for Relief from Stay Re: Fee Amount $176, Objections due by 02/12/2014. (Attachments: # (1) Exhibit Memorandum in Support of Motion for Limited Relief From Stay on Behalf of Movants) (Gonzalez, Ervin)
quoted here
Look at what one of DOJ and US Attorney's Offices Top Priorities is for 2014!!
Enforcement Priorities looking ahead to 2014:
- Manufacturing of Adulterated Drugs (Compounded Drugs) – view our recent coverage on compounding
Subscribe to:
Posts (Atom)