FDA Roundup: September 1, 2023 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:  On Thursday, the FDA cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer (DTC) test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected from individuals 18 years or older. The test was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test.  The test analyzes DNA from a self-collected saliva sample and generates personalized reports that describe if the genetic variants detected in that sample are associated with an increased risk of developing breast and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers. The variants included in this report do not represent the majority of the BRCA1/BRCA2 variants in people of most ethnicities. This means a negative result does not rule out the presence of other variants that increase cancer risk. These reports provide genetic information to inform discussions with a healthcare professional. Consumers and health care providers should not use the test results to substitute for healthcare visits for recommended cancer screenings or appropriate follow-up, and results from this test should not be used to determine any treatments.  This is the latest example of the FDA’s ongoing commitment to advance access to safe and effective DTC genetic testing intended to aid patients in having informed conversations with their healthcare providers. On Wednesday, the FDA issued a Safety Alert to advise restaurants and retailers not to serve or sell and consumers not to eat certain cultured mussels from East River Shellfish, Inc. due to a possible salmonella and E. coli contamination.

 2023 PDA/ FDA Joint Regulatory Conference | September 18 - 20, 2023

 FDA is notifying consumers of a product marketed for pain relief that has been found to contain hidden ingredients and might pose a significant health risk.

• Public Notification: Tapee Tea contains hidden drug ingredients

Immediate public notifications are issued when FDA testing finds that a product contains active drug ingredients not listed on the product labels, possibly including ingredients found in prescription drugs. These products might cause potentially serious side effects and might interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products. 

FDA's Health Fraud Product Database includes only a small fraction of the potentially dangerous products marketed to consumers online and in stores. Even if a product is not included in this list, consumers should exercise caution before using these types of products.

Learn More

 

1. www.star-telegram.com › news › localFort Worth Pharmacy owner convicted of money laundering ...

   Jul 29, 2023 · A Fort Worth pharmacy owner was found guilty Thursday of paying illegal marketing kickbacks and money laundering, officials said. Richard Hall, 53, was co-owner of Rxpress...

texaslawbook.net › jurors-have-case-against-fwJurors Have Case Against FW Pharma Boss - The Texas Lawbook

Jul 26, 2023 · Jury deliberations began Wednesday in the federal fraud trial of Fort Worth pharmacy owner Richard Hall, who is accused of cheating U.S. taxpayers out of $55 million by billing

 

Alabama pharmacists concerned about new workplace ...

Alabama Reflector

https://alabamareflector.com › 2023/07/25 › alabama-...

Jul 25, 2023 — The regulation would affect compounding pharmacies and retail pharmacies that make these drugs, or “compound” them by combining, mixing, or altering ingredients ...

 

Okla. Admin. Code § 535:15-10-64.1

Casetext

https://casetext.com › chapter-15-pharmacies › section...

Aug 1, 2023 — (d) Compounding with bulk chemicals for food-producing animals is not permitted. (e) It is acceptable for any licensed pharmacy to compound animal drugs from .

Wall Street Journal Article About Drug Shortages being a Boon to Compounding Pharmacies

 

Drug Shortages Are a Boon to One Industry: Compounding ...

Wall Street Journal

https://www.wsj.com › articles

Aug 7, 2023 — Relentless drug shortages are fueling a niche sector that operates outside the realm of the traditional pharmaceutical industry: compounding pharmacies.

 

Contents - Utah Medicaid

Utah.gov

https://medicaid.utah.gov › pdfs › Pharmacy

Jul 21, 2023 — I. Pharmacy Services Introduction . ... Compounded Prescriptions . ... Compound Billing Alert to ensure compound claims are being billed correctly. For.

 

Kentucky Board of Pharmacy - Kentucky.gov

Kentucky Board of Pharmacy (.gov)

https://pharmacy.ky.gov › Pages

Aug 10, 2023 — USP 795 and 797 Updates. ​​​On November 1, 2022, United States Pharmacopeia (USP) published revisions to their pharmaceutical compounding standards chapter 795 ...

 

NYRx, Pharmacy Manual Policy Guidelines

eMedNY

https://www.emedny.org › Pharmacy › PDFS

Aug 5, 2023 — The NY Medicaid compound policy is further clarified below: • Only the dispensing pharmacy may prepare the prescribed compounded prescription.