PCCA's compounding pharmacist members call on Congress ...

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5 days ago — PCCA's compounding pharmacist members call on Congress to protect patient access to compounded medication. PCCA. Thu, May 12, 2022,

 

Coronavirus (COVID-19) Update: FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Vaccine Booster Dose to Children 5 through 11 Years Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 5 through 11 years of age at least five months after completion of a primary series with the Pfizer-BioNTech COVID-19 Vaccine.  “While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said FDA Commissioner Robert M. Califf, M.D. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19. Vaccination continues to be the most effective way to prevent COVID-19 and its severe consequences, and it is safe. If your child is eligible for the Pfizer-BioNTech COVID-19 Vaccine and has not yet received their primary series, getting them vaccinated can help protect them from the potentially severe consequences that can occur, such as hospitalization and death.”    On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine. Today’s action expands the use of a single booster dose of the vaccine for administration to individuals 5 through 11 years age at least five months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in individuals 16 years of age and older. “The Pfizer-BioNTech COVID-19 Vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose of the vaccine in all authorized populations. The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups.” Data Supporting Effectiveness The EUA for a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age is based on FDA’s analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial that supported the October 2021 authorization of the Pfizer-BioNTech COVID-19 Vaccine primary series in this age group. Antibody responses were evaluated in 67 study participants who received a booster dose 7 to 9 months after completing a two-dose primary series of the Pfizer-BioNTech COVID-19 Vaccine. The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose. FDA Evaluation of Safety The safety of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine in this age group was assessed in approximately 400 children who received a booster dose at least five months (range 5 to 9 months) after completing a two-dose primary series. The most commonly reported side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills and fever. The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members. The FDA will make available on its website relevant documents regarding today’s authorization.  The amendment to the EUA was granted to Pfizer Inc.

 

FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Part of the U.S. Food and Drug Administration’s mission is to protect and promote public health by helping to ensure that safe, effective, quality drugs are available to patients. Drugs are not available to patients if they are in shortage. The 2019 report Drug Shortages: Root Causes and Potential Solutions found that a root cause of past drug shortages is that the market does not recognize and reward drug manufacturers that have invested in achieving quality management maturity (QMM). QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes in place to achieve quality objectives and promote continual improvement. Such business processes reduce the likelihood of supply disruptions and shortages.

To incentivize drug manufacturers to invest in QMM, the FDA has released a white paper that describes key considerations for measuring and rating a drug manufacturer’s quality management maturity, and their ability to deliver high-quality drugs reliably and without disruption. A QMM rating system could inform regulators and drug purchasers (e.g., distributors that ship drugs from manufacturers to pharmacies) about the performance and robustness of drug manufacturing facilities and give patients increased confidence in the availability of drugs. We are eager to engage with stakeholders on the development of a quality management maturity program and will be hosting a two-day workshop this month on May 24 and 25 for stakeholders to discuss their thoughts, perspectives and feedback.

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FDA compounding committee sets meeting | NCPA - National ...

https://ncpa.org › newsroom › qam › 2022/05/06 › fda...

5 days ago — FDA announced that the Pharmacy Compounding Advisory Committee will meet on June 8. The committee will discuss the following four bulk drug substances ..

 

05/09/2022	05/04/2022	Assault Labs	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	New York Nutrition Company	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Ironmag Labs	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Advanced Nutritional Supplements LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Exclusive Nutrition Products, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Steel Supplements Inc	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated

05/10/2022	04/11/2022	Brigham and Women’s Hospital Inc.	Office of Pharmaceutical Quality Operations Division I	CGMP/Positron Emission Tomography (PET) Drugs/Adulterated
05/10/2022	04/21/2022	MCACO, LTD	Division of Human and Animal Food Operations West III	CGMP/Dietary Supplement/Adulterated
05/10/2022	03/08/2022	Purina Animal Nutrition LLC	Division of Human and Animal Food Operations West III	CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
05/10/2022	05/04/2022	Inhousepharmacy.vu	Center for Drug Evaluation and Research | CDER	Notice of Unlawful Sale of Unapproved Drugs to United States Consumers Over the Internet
05/10/2022	05/02/2022	David Cosmetic Co., Ltd.	Center for Drug Evaluation and Research | CDER	CGMP/Finished Pharmaceutical/Adulterated
05/10/2022	04/29/2022	Beachside Vapors LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
05/09/2022	05/04/2022	Nutritional Sales and Customer Service, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Max Muscle	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Complete Nutrition	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated
05/09/2022	05/04/2022	Performax Labs Inc	Center for Food Safety and Applied Nutrition (CFSAN)	Dietary Supplement/Adulterated

New York Racehorse Veterinarian And Standardbred Trainer Plead Guilty In Federal Doping Case Veterinarian Louis Grasso and Racehorse Trainer Richard Banca Used Their Positions to Acquire, Distribute and Administer Prohibited Performance Enhancing Drugs

New York Racehorse Veterinarian And Standardbred Trainer Plead Guilty In Federal Doping Case Veterinarian Louis Grasso and Racehorse Trainer Richard Banca Used Their Positions to Acquire, Distribute and Administer Prohibited Performance Enhancing Drugs Damian Williams, the United States Attorney for the Southern District of New York, announced that defendants LOUIS GRASSO and RICHARD BANCA pled guilty to their respective roles in the distribution of adulterated and misbranded drugs with the intent to defraud and mislead, in connection with the charges filed in United States v. Grasso et al., 20 Cr. 163 (OKC). Both GRASSO and BANCA pled guilty before U.S. District Judge P. Kevin Castel. GRASSO and BANCA will each be sentenced by Judge Castel on September 6, 2022. Read More Button

Oklahoma Board of Pharmacy Needs Volunteers

 Task Force/Committee Volunteers Needed 

 

The Board of Pharmacy is needing volunteers to create a Task Force/Committee for evaluating temperature excursions and the shipping of prescriptions by pharmacies to patients who are located in state and out of state.

This Task Force/Committee will more than likely need to evaluate the potential of creating rule changes to the existing rules.

All interested parties will need to submit the below items to Marty Hendrick via email at Mhendrick@pharmacy.ok.gov to be considered for this task force. 

 

• Letter of interest on serving on the Task Force/Committee.
• Resume of pharmacy work experience.
• Past experience in a pharmacy practice that involves shipping prescriptions to patients.

 

535:15-3-11. Prescription drugs 

(f) Prescription shipping. The pharmacy shall maintain and use adequate storage or shipping containers and use shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process. 

 

(1) No prescription shipped to a citizen of Oklahoma should have a temperature excursion that exceeds the temperature storage conditions outlined within the package insert or by the manufacturer of the drug product. 

 

(2) A pharmacy or pharmacist shall refuse to deliver by mail or common carrier a prescription drug which, in the professional opinion of the pharmacy or pharmacist may be therapeutically compromised by delivery by mail or common carrier. 

 

(3) A mail order or non-resident pharmacy shall make available to the patient or patient's caregiver the contact information for the Oklahoma State Board of Pharmacy.

 

Court

Jury Convicts Lisa Giannelli For Marketing and Selling Hundreds of Untestable Performance Enhancing Drugs to Racehorse Trainers Across the United States

Damian Williams, the United States Attorney for the Southern District of New York, announced the conviction at trial of defendant LISA GIANNELLI, on one count of drug adulteration and misbranding, with intent to defraud and mislead, in connection with a nearly twenty-year scheme to create and distribute “untestable” performance enhancing drugs for use in professional horseracing. GIANNELLI was one of over thirty defendants charged in four separate cases in March 2020, each arising from this Office’s multi-year investigation of the abuse of racehorses through the use of performance enhancing drugs.

 Horse racing is on the cusp of major changes in the U.S. after years of scandal

A newly formed regulatory authority for horse racing is introducing new standards for the sport. Some stakeholders are pushing back.

Read in NPR: https://apple.news/AkI0lXcNBSyupVv7Bte8c9w