09/12/2023	09/11/2023	OcluMed LLC	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
09/12/2023	09/11/2023	DR Vitamins, LLC dba DR Vitamin Solutions	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded

 

09/12/2023	09/05/2023	Safecor Health, LLC	Division of Pharmaceutical Quality Operations I	CGMP/Finished Pharmaceuticals/Adulterated
09/12/2023	08/21/2023	RickinmortyBars	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/12/2023	09/01/2023	Vape Society Supply	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
09/12/2023	07/18/2023	Del Valle Import & Export 3, Inc. DBA El Progreso Imports	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
09/12/2023	09/11/2023	Natural Ophthalmics, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
09/12/2023	09/11/2023	Boiron, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
09/12/2023	09/11/2023	Similasan AG	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
09/12/2023	09/11/2023	TRP Company, Inc	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
09/12/2023	09/11/2023	Walgreens Boots Alliance, Inc.	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded
09/12/2023	09/11/2023	CVS Health	Center for Drug Evaluation and Research | CDER	Unapproved New Drugs/Misbranded

 

2023 PDA/ FDA Joint Regulatory Conference

September 18 - 20, 2023

 

FDA Seeks Public Comment on Guidance Related to Informed Consent for Companion Animal Studies

Today, the U.S. Food and Drug Administration is announcing the availability of draft guidance for industry that will help ensure that animal owners who are considering having their pet participate in a clinical study for a new animal drug understand the risks and benefits of their participation. Draft Guidance for Industry (GFI) #282, entitled “Informed Consent Forms for Studies that Enroll Client-Owned Companion Animals,” outlines the basic elements of informed consent in animal drug clinical studies.

Informed consent is a documented process by which an animal’s owner – or someone acting on behalf of the owner – voluntarily confirms the owner’s willingness to allow their animal(s) to participate in a particular study, after having been informed of all aspects of the study that may be relevant to the owner’s decision to participate. An animal drug sponsor or investigator (the individual responsible for all aspects of the conduct of the study at their study site) should ensure that the owner is provided with adequate information and time to allow for an informed decision about whether they want to voluntarily participate in a clinical investigation.

 

NCBOP - Pharmacist FAQs

North Carolina Board of Pharmacy

http://www.ncbop.org › faq_compoundedproducts

5 days ago — Q: What federal law governs the preparation of compounded drug products? A: The Drug Quality and Security Act of 2013 (“DQSA”) broadly governs the compounding ...

 

Premier Comments on CMS Proposed Remedies for ...

premierinc.com

https://premierinc.com › Newsroom

1 day ago — ... outlining its remedy for reversing its 340B-acquired drug payment policy, ... on the statutory prohibition on wholesaling for certain compounded drugs.

 

FAQs about extralabel drug use

American Veterinary Medical Association

https://www.avma.org › faqs-about-extralabel-drug-use

2 days ago — Note that ELDU covers not just FDA-approved animal drugs and human prescription drugs but also FDA-approved human over-the-counter products and compounded

 

CDERLearn Training and Education

Food and Drug Administration (.gov)

https://www.fda.gov › cderlearn-training-and-education

5 days ago — September 26, 2023: FDA Drug Topics: Regulatory Framework for Human Drug Compounding - September 26, 2023; September 28, 2023: Electronic Drug Registration 

 

Chapter 3, Article 5 3.5.24, Handling of National Institute for ...

California Correctional Health Care Services (.gov)

https://cchcs.ca.gov › HCDOM-ch03-art5.24.pdf

5 days ago — Sterile hazardous drugs shall only be compounded by pharmacies with appropriate licensure from the California State Board of Pharmacy. (b) Purpose.

 

Compound Drugs Administered for Pain Management May ...

Palmetto GBA

https://www.palmettogba.com › jmb.nsf › DIDC › 8W...

2 days ago — Services are rejected if the criterion listed above is not met when billing for compounded medications. Rejected services must be submitted as new claims, and ..