| 01/09/2018 | Hunan Norchem Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
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
Tuesday, January 30, 2018
FDA, USDA announce formal agreement to bolster coordination and collaboration
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Monday, January 29, 2018
COMBATING THE OPIOID CRISIS
Energy and Commerce has been at the tip of the spear in the national fight to combat the opioid crisis. Follow along in our efforts here.
Question of the Day January 29, 2018 How does the FDA make sure "it obtains the necessary data to identify large-scale, multi-state distributors, to help focus our inspection and enforcement resources on the subset of pharmacy compounders that engage in compounding activities that merit FDA oversight if owners of these types of compounding pharmacies serve on the state board of pharmacies? What should the FDA do then?
"With respect to section 503A pharmacies, we are working with the states to obtain the necessary
data to identify large-scale, multi-state distributors, to help focus our inspection and enforcement
resources on the subset of pharmacy compounders that engage in compounding activities that
merit FDA oversight." quote from The Honorable Scott Gottlieb, M.D., Commissioner, Food and Drug Administration, Witness Statement, found here
FDA has "conducted close to 500 inspections of 503A and 503B facilities between the passage of DQSA and the end of fiscal year 2017. We have observed problematic conditions during the vast majority of these inspections and have overseen more than 150 recalls of compounded drugs and issued more than 180 warning letters."
quoted from The Honorable Scott Gottlieb, M.D., Commissioner, Food and Drug Administration, Witness Statement, found here
EXAMINING IMPLEMENTATION OF THE COMPOUNDING QUALITY ACT--Hearing Scheduled for January 30, 2018--Link to webcast and hearing documents
WITNESSES
The Honorable Scott Gottlieb, M.D.
Commissioner, Food and Drug Administration (FDA)
Commissioner, Food and Drug Administration (FDA)
Ms. Jenn Adams
Senior Vice President and President, Clinical Product Solutions, PharMEDium Services
Senior Vice President and President, Clinical Product Solutions, PharMEDium Services
Dr. Bruce Brod
Chair, Congressional Policy Committee, American Academy of Dermatology Association
Chair, Congressional Policy Committee, American Academy of Dermatology Association
Ms. Nancy Dargan
Mr. Shawn Hodges
Vice President, International Academy of Compounding Pharmacists
Vice President, International Academy of Compounding Pharmacists
Ms. Elizabeth Jungman
Director, Public Health, The Pew Charitable Trusts
Director, Public Health, The Pew Charitable Trusts
Mr. Jacob Olson
President and CEO, Skywalk Pharmacy, on behalf of National Community Pharmacists Association
President and CEO, Skywalk Pharmacy, on behalf of National Community Pharmacists Association
Ms. Molly Ventrelli
Vice President, Regulatory Affairs, Fresenius Kabi
Vice President, Regulatory Affairs, Fresenius Kabi
Dr. George Williams
President Elect, American Academy of Ophthalmology
President Elect, American Academy of Ophthalmology
DOCUMENTS
The hearing
webcast will be available at http://energycommerce.house.gov/.
Associate Attorney General Brand Announces End To Use of Civil ...
4 days ago - Associate Attorney General Brand Announces End To Use of Civil Enforcement Authorityto Enforce Agency Guidance Documents. Today, as a follow-up to a memo issued by Attorney General Jeff Sessions in November, the Office of the Associate Attorney General issued a new policy that prohibits the ...
Missing: iacprx
Assoc Atty Gen Brand Ends Use of Civil Enforcement Authority to ...
Assoc Atty Gen Brand Ends Use of Civil Enforcement Authority to Enforce Agency Guidance Documents. 22 hours ago (0 Comments) Posted by: Dagmar Anderson
3 Orlando doctors convicted of $4.3M kickback scheme involving ...
Orlando Sentinel-1 hour ago
Larry Howard, owner of Fertility Pharmacy in Oviedo; Dr. Nicole Bramwell of Apopka; and Raymond Stone of Orlando were convicted for their role in a kickback scheme that involved pain and scar creams, totaling $4.3 million in false and fraudulent claims to TRICARE between October 2014 and May 2015, according to the ...
As flu worsens, Cuomo executive order lets pharmacists give shots ...
The Livingston County News-2 hours ago
25 and also issued an executive order that suspends education law requirements related to the administration of immunization by pharmacists. The executive order will allow pharmacists to administer flu vaccines to minors between the ages of 2 and 18 years old, and allow non-patient specific orders to allow pharmacists to ...
"A Utah pharmacy and the husband-and-wife owners of a Tennessee medical practice have been indicted on allegations that they used Marines and sailors in San Diego County as pawns in a nearly $66 million medical insurance scheme, according to an indictment unsealed Friday."
Husband-Wife Duo Indicted In Case Involving Pharmacy Scam On ...
California Healthline-2 hours ago
A Utah pharmacy and the husband-and-wife owners of a Tennessee medical practice have been indicted on allegations that they used Marines and sailors in San Diego County as pawns in a nearly $66 million medical insurance scheme, according to an indictment unsealed Friday. Jimmy and Ashley Collins, who own ...
Amazon's exploratory pharmacy team has ballooned to more than ...
Pharmacy Today, American Pharmacists Association, pharmacist.com-3 hours ago
Leerink, a financial research firm, says in a new report that Amazon is expanding its team created to explore a move into the pharmacy business. An anonymous former senior Amazon employee said the exploratory team has increased fro
People in Pain Petition the FDA: Cease, Halt, and Refocus!
National Pain Report-6 hours ago
... (some of them diverted prescription drugs) rather than by prescriptions made by doctors to chronic pain patients, CDC has continued to double-down on its errors. They have thus far refused even to consider withdrawing the guidelines for a major and very needed rewrite. The US Veterans Administration has compounded ...
People in Pain Petition the FDA: Cease, Halt, and Refocus!
National Pain Report-6 hours ago
... (some of them diverted prescription drugs) rather than by prescriptions made by doctors to chronic pain patients, CDC has continued to double-down on its errors. They have thus far refused even to consider withdrawing the guidelines for a major and very needed rewrite. The US Veterans Administration has compounded ...
35-year sentence sought for pharmacist in meningitis case for ...
The Tennessean-23 minutes ago
The outbreak was caused by contaminated drugs shipped by the New England Compounding Center, the now-defunct Framingham, Mass., firm where Cadden and Chin worked. Cadden was president and part owner of NECC, and Chin ran the clean room where the contaminated drugs were produced. In a footnote in the ...
TherapeuticsMD (TXMD): Hidden Opportunity In FDA Compounding ...
StreetInsider.com-4 hours ago
That outbreak, along with other FDA concerns about compounded drugs, emphasized the need for better control of compounding practices and oversight of compounding pharmacies. W e see TX-001HR, as potentially the first and only bio-identical FDA-approved combination of 17 β-estradiol and progesterone, as uniquely ...
One patient's experience in Germany requesting post-surgical opioids her doctors said she wouldn't need -- and admitting they were right. (New York Times)
Friday, January 26, 2018
Tricare: Users Overcharged for Drugs Will Receive Refund Checks
Military.com-7 hours ago
Thousands of Tricare users who were overcharged for drugs in early January after the system's pharmacy contractor misunderstood a series of system changes will be sent refunds by mail, Tricare officials said today. Express Scripts, which manages the system's pharmacy program and originally said 35,000 users were ...
'Frazzled' Boots pharmacist mixed up patient's pills
BBC News-3 hours ago
A patient has described suffering "horrendous" symptoms for three days after a Boots pharmacy gave him the wrong medication. The 51-year-old was prescribed a drug to help with his insomnia, but was given one for high blood pressure with a similar name. He believes Boots pharmacy staff are overworked and this led to ..
Texas Board of Pharmacy Rules Update
Rules adopted at the November 2017 Board Meeting were published as adopted in the December 29, 2017 issue of the Texas Register and became effective January 4, 2018. Rules proposed at the November 2017 Board meeting are posted in the December 29, 2017 issue of the Texas Register. The proposed rules will be considered for adoption at the next TSBP board meeting on February 6, 2018.
You may view a summary of the adopted and proposed rules here.
You may view a summary of the adopted and proposed rules here.
| Endo Agrees To Pause Lawsuit After FDA Promises New Bulks Guidance
Endo Pharmaceuticals has agreed to a temporary stay of its lawsuit against FDA over the agency's interim policy on compounding using bulk substances until the agency releases new guidance to significantly rework the controversial policy. As Inside Health Policy previously reported, Endo sued FDA in ...
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| FDA Continues to Prioritize Compounding Regulation with the 2018Compounding Policy Priorities ...
A component of the Federal Food, Drug and Cosmetic Act (FD&C Act) is the restrictions it places on compounding drugs that are essentially copies of FDA-approved or commercially available products. On January 19, 2018, FDA issued two final guidance documents regarding the copies provisions for ...
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New Bulk Substance Compounding Guidance Coming In 2018
| New Bulk Substance Compounding Guidance Coming In 2018
In the wake of a controversial policy that ended up getting the agency sued, FDA announced it will release new guidance in March on determining the clinical need to warrant compounding using bulk substances, which one source familiar with the drafting and negotiations around the compounding la
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Experts: Federal, State Oversight Of 503B Compounding Falls Short
Inside Health Policy-13 hours ago
... and enforcement of the current guidelines is too lax, according to a recent white paper that came out of roundtable discussions with top compounding experts. The paper also paints a stark picture of compounders' compliance with best practices and physician knowledge of when drugs they administer are compounded.
The Ins and Outs of Limited Distribution Specialty Drugs
21 hours ago - In many drug product releases, especially in the world of specialty pharmaceuticals, manufacturers will often limit the number of specialty pharmacies that can dispense its medications. Pharmaceutical manufacturers will determine this distribution strategy based on product characteristics, patient education, market reach, ...
Question of the Day January 26,2018 What questions should Congress during the Hearing, entitled, "Examining Implementation of the Compounding Quality Act" scheduled for January 30, 2018? Besides just addressing quality and safety issues with compounded drugs should Congress examine and address the unbelievable amount of fraud (e.g., the compounding pain cream schemes) in the compounding industry?
HEARING: #SubHealth to Conduct Check Up on Safeguards for ...
2 days ago - WASHINGTON, DC – The Health Subcommittee, chaired by Rep. Michael C. Burgess, M.D. (R-TX), today scheduled a hearing for Tuesday, January 30, 2018, at 11 a.m. in room 2123 of the Rayburn House Office Building. The hearing is entitled, “Examining Implementation of the CompoundingQuality Act.” #
Examining Implementation of the Compounding Quality Act - Energy ...
2 days ago - The hearing is entitled, “Examining Implementation of the Compounding Quality Act.” #SubHealth will examine the U.S. Food and Drug Administration's (FDA) implementation of Title I of the Drug Quality and Security Act (DQSA), which was enacted nearly five years ago in the wake of the fungal meningitis outbreak caused ...
Examining Implementation of the Compounding Quality Act ...
2 days ago - Meeting: Examining Implementation of the Compounding Quality Act. Subcommittee on Health (Committee on Energy and Commerce). Tuesday, January 30, 2018 (11:00 AM). 2123 RHOB Washington, D.C.. Support Documents. Hearing Notice [PDF]. First Published: January 23, 2018 at 04:04 PM
Thursday, January 25, 2018
| 12/05/2017 | Hieber's Pharmacy | New Jersey District Office | Compounding Pharmacy/Adulterated Drug Products | Not Issued * |
| 11/29/2017 | BBCOS srl | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
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