Expiration Dating of Drugs and Diagnostics- Covid Test Kits Free

The following news last week, reminded me of my previous articles regarding expiration dating of drugs.  ( see link on end of this article for details).

1 million expired COVID tests sitting in Florida warehouse OK to use after FDA grants extension-Jan 13, 2022

Gov. Ron DeSantis said the tests hadn't been distributed due to low demand.

The U.S. Food and Drug Administration has extended the shelf life of up to 1 million rapid COVID-19 tests that had expired in a Florida warehouse.

Earlier this month, Gov. Ron DeSantis' administration revealed between 800,000 and 1 million Abbott BinaxNOW COVID-19 tests had sat idle in a warehouse and expired in December.

I just ordered my free covid test kit today. No problem with the website and I completed it in less than one minute. Order yours at www.covidtests.gov   

 

Here are some popular questions often ask and a brief response for your reading pleasure and clarification:  

 

What does the expiration date on drugs mean?

Drug expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions.

 

Do drug tests work after they expire?

Are expiry dates on drugs accurate?

What they found from the study is 90% of more than 100 drugs, both prescription and over-the-counter, were perfectly good to use even 15 years after the expiration date. So, the expiration date doesn't really indicate a point at which the medication is no longer effective or has become unsafe to use.

 

How long after expiry date can drugs be used?

 

Ongoing research shows that stored under optimal conditions, many drugs retain 90% of their potency for at least five years after the labeled expiration date, and sometimes longer. Even 10 years after the expiration date many pharmaceuticals retain a significant amount of their original potency.

 

How long can you use after expiration date?

You can eat food after the sell-by date. For example, dairy products are good for 1 week after the sell-by date. Eggs are safe for 3 to 5 weeks after the sell-by date.

https://marinduqueawaitsyou.blogspot.com/2014/08/an-update-on-drugs-and-its-expiration.html

Please read the above site on my take about drug expiration dating.

 

Celebrating Martin Luther King Jr Day, Voting Rights Bill and the EEOC

My 1998 Equal Opportunity Achievement Award Plaque (FDA)

Today we are celebrating the life and achievements of Martin Luther King (MLK) as a National Holiday. 

Martin Luther King Jr. Day honors the famous American civil rights leader who dedicated his life to achieving equality for people of all colors. In today news, the MLK family is urging the passing of the Voting Rights Bill.

My personal involvement with equal rights dated way back in 1998 when I received an achievement Plaque and the FDA EEO award ( see photo above).

https://lifeinus1960present.blogspot.com/2021/08/my-awards-honors-and-scientific.html 

Today our younger generations( my grand children and yours) do not have a clear idea and historical facts of the creation and achievements of this not too well-known Federal Government Commission (EEOC). I am taking this opportunity to post a summary on the achievements of this government entity as follows:   

The Equal Employment Opportunity Commission (EEOC) is a government entity created to eliminate discrimination in the workplace in the U.S. based on an employee’s race, gender, color, religion, national origin, age, disability, or gender. These “immutable characteristics” have no impact on how an employee can perform their job and cannot be used as a means to discriminate. The EEOC wasn’t always around to protect employee rights, but during the 1960’s, when integration and racial issues became heated, it was obvious that certain protections were necessary.

1963

Congress passed the Equal Pay Act of 1963 (EPA), which protected men and women from sex-based wage discrimination for performing the same job. This Act was the first national civil rights legislation that focused on employment discrimination.

Just months later, in August of 1963, almost 250,000 Americans marched in Washington, D.C. for racial equality. This was the largest protest for racial equality in U.S. history up to that time and included Martin Luther King Jr.’s famous “I have a dream” speech.

1964

The Civil Rights Act of 1964 was signed into law by President Lyndon B. Johnson and included a section (referred to as Title VII) which prohibited employment discrimination. This Act applied to private employers, labor unions and employment agencies and created the EEOC to enforce the Act.

1965

On July 2nd, the EEOC opens its doors for business. The EEOC was given a budget of $2.25 million and employed over 100 people.

1967

Congress passed the Age Discrimination Employment Act of 1967, which protected employees between 40 and 65 years old from employment discrimination. This Act protected older employees from being unfairly laid off, not receiving their earned health benefits and being overlooked for promotions. Since 1978 the Act even prohibited mandatory retirement in most business sectors.

1978

Congress amended Title VII by passing the Pregnancy Discrimination Act of 1978, which clarified that discrimination of a pregnant woman did indeed fall under the category of employment discrimination based on a person’s gender.

1990

The Americans with Disabilities Act of 1990 was signed into law. The EEOC became responsible for enforcing Title I of the ADA.  This states that private employers, government jobs, unions and employment agencies cannot discriminate against a qualified employee or applicant due to a disability. For Details visit:

https://jeffdavislawfirm.com/a-brief-history-of-the-equal-employment-opportunity-commission/ 

 

Admiring the Career of Dr. Janet Woodcock- Acting FDA Commissioner

Dr Woodcock was the Director of the Center of New Drug Evaluation and Research when I was still working at FDA ( 1990 -2002). Today she is the Acting FDA Commissioner and almost every week, I see her face in National TV along with Dr Fauci and CDC Director Walensky. Seeing her face in National TV, reminds me of her picture and myself as follows:

       

From Wikipedia:

Janet Woodcock (born August 29, 1948) is an American physician who is currently serving as the acting Commissioner of the U.S. Food and Drug Administration (FDA).  She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.

Woodcock has overseen the modernization and streamlining of CDER and FDA, introducing new initiatives to improve the timeliness and transparency of FDA procedures, and the safety, quality and effectiveness of drugs. She informs the United States Congress and other government bodies about the FDA and its concerns, helping to develop policy recommendations and legislation. In 2015, Woodcock received a Lifetime Achievement Award from the Institute for Safe Medication Practices in recognition of “a significant career history of making ongoing contributions to patient safety.” She has also received the 2019 Biotechnology Heritage Award.

When I saw her face in TV last month, I can not help but admire the long and successful career Dr Woodcock has accomplished. I thought she had retired, but to my surprise she is still a public servant and doing her best to accomplish FDA mission.  

FDA mission statement is “protecting consumers and enhancing public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products.” 

For complete details of Dr Woodcock's biography and accomplishments visit:

https://en.wikipedia.org/wiki/Janet_Woodcock 

Meanwhile on November 2021, President Biden issued a statement announcing his intention to nominate Dr. Robert Califf as the new FDA Commissioner as follows:  

Statement from President Joe Biden Announcing His Intention to Nominate Dr. Robert Califf for Commissioner of Food and Drugs

November 12, 2021 • Statements and Releases

I first want to thank Dr. Janet Woodcock for her leadership over the last year. She has done an incredible job leading the agency during what has been a busy and challenging time, and both she and the FDA career staff have worked hard and followed the science to ensure the American public can trust the decisions being made by the FDA.

Dr. Robert Califf is one of the most experienced clinical trialists in the country, and has the experience and expertise to lead the Food and Drug Administration during a critical time in our nation’s fight to put an end to the coronavirus pandemic. As the FDA considers many consequential decisions around vaccine approvals and more, it is mission critical that we have a steady, independent hand to guide the FDA. I am confident Dr. Califf will ensure that the FDA continues its science and data driven decision-making. Dr. Califf had strong bipartisan support in the Senate in 2016, and I urge the Senate to swiftly confirm Dr. Califf so he can continue the important work being done at this critical moment.

Dr. Robert Califf, Nominee for Commissioner of Food and Drugs

Dr. Califf is an internationally recognized expert in clinical trial research, health disparities, healthcare quality, and cardiovascular medicine. He brings nearly four decades of experience as a doctor, researcher, leader, and public servant, including previous service as FDA Commissioner from 2016-2017, for which he was confirmed by the Senate 89-4 with broad bi-partisan support. Currently, Califf is a professor of medicine at the Duke University School of Medicine, where he previously served as Vice Chancellor and founded the Duke Clinical Research Institute, and also works as Head of Clinical Policy at Verily Life Sciences, a life sciences research organization. Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

Current Update:

Senate Panel OKs Califf Nomination for FDA Chief - The New ...

https://www.nytimes.com › health › fda-robert-califf

3 days ago — A divided Senate committee on Thursday advanced the nomination of Dr. Robert Califf to become commissioner of the Food and Drug ...

 

It looks like in the next few days, FDA will have a New FDA Commissioner. Thank You, Dr Woodcock for your long service and leadership. 

 

 Dr. Robert Califf- FDA Nominee for Commissioner, 2021-2022

 

Chemistry, Manufacturing and Control (CMC) Requirements for the Development of new Drugs in the US

My next door neighbor who was curious about my previous employment asked me again this morning of what I was doing before my retirement. It reminded me of an article I posted a couple of years ago that I am reposting today.

Chemistry, Manufacturing and Control (CMC) Requirements For Drug Development in US

In my previous posting several weeks ago, I discuss a general overview of new drug development and FDA's role in the process. In this article I am focusing on the Chemistry portion of a new drug application (NDA) which was my expertise when I was still working for FDA from September, 1990 up to October, 2002. I am listing below a table of all CMC guidances both in draft and final form. As a former Chemistry team leader in one of the divisions in the Center of New Drugs, I have some input on the contents of a few of these guidances. These guidances are available in the Internet for everyone.

Below is a table of Chemistry, Manufacturing and Controls (CMC) Guidances showing, category, title status( draft or final) and date.

1. Chemistry, Manufacturing, and Controls (CMC) Analytical Procedures and Methods Validation (PDF - 91KB)1 Draft Guidance 08/30/00

2. Chemistry, Manufacturing, and Controls (CMC) Assay Development for Immunogenicity Testing of Therapeutic Proteins (PDF - 161KB)2 Draft Guidance 12/04/09

3. Chemistry, Manufacturing, and Controls (CMC) Botanical Drug Products (PDF - 437KB)3 Final Guidance 06/01/04

4. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (PDF - 33KB)4 Final Guidance 07/01/97

5. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA (PDF - 108KB)5 Final Guidance 04/01/04

6. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA: Questions and Answers (PDF - 35KB)6 Final Guidance 01/01/01

7. Chemistry, Manufacturing, and Controls (CMC) Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (PDF - 18KB)7 Final Guidance 11/19/04

8. Chemistry, Manufacturing, and Controls (CMC) CMC Postapproval Manufacturing Changes Reportable in Annual Reports (PDF - 78KB)8 Draft Guidance 06/24/10

9. Chemistry, Manufacturing, and Controls (CMC) Comparability Protocols -- Chemistry, Manufacturing, and Controls Information (PDF - 240KB)9 Draft Guidance 02/25/03

10. Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for Packaging Human Drugs and Biologics (PDF - 164KB)10 Final Guidance 05/01/99

11.Chemistry, Manufacturing, and Controls (CMC) Container Closure Systems for
Packaging Human Drugs and Biologics -- Questions and Answers (PDF - 15KB)11 Final Guidance 05/01/02

12. Chemistry, Manufacturing, and Controls (CMC) Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products12 Final Guidance 04/01/96

13, Chemistry, Manufacturing, and Controls (CMC) Development of New Stereoisomeric Drugs13 Final Guidance 05/01/92

14. Chemistry, Manufacturing and Controls (CMC) Drug Master Files (DMFs)14 Additional Information regarding DMF's

15. Chemistry, Manufacturing, and Controls (CMC) Drug Master Files for Bulk Antibiotic Drug Substances (PDF - 23KB)15 Final Guidance 11/01/99

16. Chemistry, Manufacturing, and Controls (CMC) Drugs, Biologics, and Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals (PDF - 88KB) Draft Guidance 09/11/02

17. Chemistry, Manufacturing, and Controls (CMC) Environmental Assessment of Human Drug and Biologics Applications (PDF - 188KB)17 Final Guidance 07/01/98

18. Chemistry, Manufacturing, and Controls (CMC) Format and Content for the CMC Section of an Annual Report (PDF - 29KB)18 Final Guidance 09/01/94

19. Chemistry, Manufacturing, and Controls (CMC) Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting (PDF - 79KB)19 Draft Guidance 07/14/09

20. Chemistry, Manufacturing, and Controls (CMC) INDs for Phase 2 and Phase 3 Studies Chemistry, Manufacturing, and Controls Information (PDF - 193KB)20 Final Guidance 05/20/03

21. Chemistry, Manufacturing, and Controls (CMC) IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information (PDF - 30KB)21 Final Guidance 05/01/01

22. Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations (PDF - 26KB)22

23. Chemistry, Manufacturing, and Controls (CMC) Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 45KB)23 Draft Guidance 08/21/02

24. Chemistry, Manufacturing, and Controls (CMC) Monoclonal Antibodies Used as Reagents in Drug Manufacturing (PDF - 29KB)24 Final Guidance 03/01/01

25. Chemistry, Manufacturing, and Controls (CMC) Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products (PDF - 361KB)25 Draft Guidance 11/19/98

26. Chemistry, Manufacturing, and Controls (CMC) Nasal Spray and Inhalation Solution, Suspension, and Drug Products (PDF - 116KB)26 Final Guidance 07/01/02

27. Chemistry, Manufacturing, and Controls (CMC) NDAs: Impurities in Drug Substances (PDF - 11KB)27 Final Guidance 02/01/00

28. Chemistry, Manufacturing, and Controls (CMC) Orally Disintegrating Tablets (PDF - 52KB)28 Final Guidance 12/17/08

29. Chemistry, Manufacturing, and Controls (CMC) PAC-ATLS: Postapproval Changes - Analytical Testing Laboratory Sites (PDF - 76KB)29 Final Guidance 04/28/98

30. Chemistry, Manufacturing, and Controls (CMC) Residual Drug in Transdermal and Related Drug Delivery Systems (PDF - 44KB)30 Draft Guidance 08/02/10

31. Chemistry, Manufacturing, and Controls (CMC) Residual Solvents in Drug Products Marketed in the United States (PDF - 52KB)31 Final Guidance 11/24/09

32. Chemistry, Manufacturing, and Controls (CMC) Reviewer Guidance, Validation of Chromatographic Methods (PDF - 703KB)32 Final Guidance 11/01/94

33. Chemistry, Manufacturing, and Controls (CMC) Size of Beads in Drug Products Labeled for Sprinkle (PDF - 43KB)33 Draft Guidance 01/18/11

34. Chemistry, Manufacturing, and Controls (CMC) Submitting Documentation for the Manufacturing of and Controls for Drug Products (PDF - 1048KB)34 Final Guidance 02/01/87

35. Chemistry, Manufacturing, and Controls (CMC) Guidelines for Submitting Samples and Analytical Data for Methods Validation Final Guidance 02/01/87

36. Chemistry, Manufacturing, and Controls (CMC) Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances (PDF - 94KB)36 Final Guidance 02/01/87

37. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation (PDF - 60KB)37 Final Guidance 11/01/95

38. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR Questions and Answers about SUPAC-IR Guidance38 Final Guidance 02/18/97

39. Chemistry, Manufacturing, and Controls (CMC) SUPAC-IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms Manufacturing Equipment Addendum (PDF - 117KB)39 Final Guidance 01/01/99

40. Chemistry, Manufacturing, and Controls (CMC) SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (PDF - 215KB)40 Final Guidance 10/06/97

41. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms Manufacturing Equipment Addendum (PDF - 61KB)41 Draft Guidance 12/01/98

42. Chemistry, Manufacturing, and Controls (CMC) SUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (PDF - 118KB)42 Final Guidance 05/01/97

43. Guidance for Industry - The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use The Sourcing and Processing of Gelatin to Reduce the Potential Risk Posed by Bovine Spongiform Encephalopathy (BSE) in FDA-Regulated Products for Human Use 09/01/97

Note: As a Chemistry Team Leader, I need to be familiar with contents of these 43 Guidances, so when representatives from the Pharmaceutical firms ask me a question, I should be able to refer them to the guidance. If I can answer their question without referring to the guidance, the firm's representative look at me with high regard and respect. 

 

It is therefore imperative that I know most of the important requirements for an New Drug application (NDA) submission as well as the post NDA requirements in the manufacture, chemistry and controls of an Investigational New Drug (IND) or NDA. A Guidance is not a Federal Regulation/Law. 21CFR (Code of Federal Regulation), but gives FDA mandate to enforce drug and food laws in US.

Source: www.fda.gov 

 

Meanwhile enjoy this photo from my collection

 

 

 

First Malaria Vaccine Approved-Top Ten Science News of 2021

 

As a retired FDA scientist( Chemistry Team Leader) and former GS-14 expert on Anti-Malarial and Anti-Parasitic Products, the news that a vaccine against Malaria had been approved fulfilled my dream and wish in life.

 

This discovery was overshadowed by covid-19 vaccines news, but made it as one of the top ten science news for 2021. At the bottom of the page is the site discussing in details of the top ten science discoveries for 2021.  

My enthusiasm and joys is that this malaria vaccine can save hundred thousands  lives of children as well as adults every year. It deserves as much publicity as the Covid-19 vaccines that dominate the news for over two years.

In October, the World Health Organization approved the first vaccine against malaria. The approval was not only a first for that disease, but also for any parasitic disease. The moment was 30 years in the making, as Mosquirix—the brand name of the drug—cost more than $750 million since 1987 to develop and test. Malaria kills nearly a half million individuals a year, including 260,000 children under the age of five. Most of these victims live in sub-Saharan Africa. The new vaccine fights the deadliest of five malaria pathogens and the most prevalent in Africa, and is administered to children under five in a series of four injections. The vaccine is not a silver bullet; it prevents only about 30 percent of severe malaria cases. But one modeling study showed that still could prevent 5.4 million cases and 23,000 deaths in children under five each year. Experts say the vaccine is a valuable tool that should be used in conjunction with existing methods—such as drug combination treatments and insecticide-treated bed nets—to combat the deadly disease.

https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk

Here's the link for the top ten science stories for the year, 2021 for your reading pleasure. 

https://www.smithsonianmag.com/science-nature/the-ten-most-significant-science-stories-of-2021-180979278/

Meanwhile here are two videos on the Malaria vaccine Discovery