| 01/24/2018 | Young Health Products | Dallas District Office | New Drug/Misbranded | 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
| 01/18/2018 | Daito Kasei Kogyo Co Ltd | Center for Drug Evaluation and Research | CGMP/Finished Pharmaceuticals/Adulterated | Not Issued * |
| 01/11/2018 | King Bio Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | CalmSupport.com, LLC | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | NutraCore Health Products | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Soothedrawal, Inc. | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded |
| 01/11/2018 | U4Life LLC dba Mitadone | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Guna Inc. | Center for Drug Evaluation and Research | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Healthy Healing dba Crystal Star | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Medicus Holistic Alternatives LLC | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | TaperAid | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Opiate Freedom Center | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/11/2018 | Choice Detox Center, Inc. dba Nofeel | Center for Food Safety and Applied Nutrition | Finished Pharmaceuticals/Unapproved New Drug/Misbranded | Not Issued * |
| 01/09/2018 | Hunan Norchem Pharmaceutical Co. Ltd. | Center for Drug Evaluation and Research | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated | Not Issued * |
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
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