Good information to share with “newly” diagnosed families and those attempting to change legislation.
It is so important to understand, permissioned “Allowance” vs. regulated requirements “Required” terms as you read your state’s legislation and federal guidelines.
I am not a lawyer. I am attaching sited public approved legislation links. That everyone should be aware of and armed with if you or your loved one has been diagnosed with Anaphylaxis.
Epinephrine Entity Stocking Laws in the U.S.
It is so important to understand, permissioned “Allowance” vs. regulated requirements “Required” terms as you read your state’s legislation and federal guidelines. I am no repeating myself, I feel it is very important.
“Although many states initially focused on making EpiPens available in a school setting, more recent legislation expands the range of organizations permitted to maintain these emergency supplies. Multiple states have passed legislation that permits but does not require, various entities to stock undesignated epinephrine for use in case of an emergency” to quote from the following PLEASE Read Epinephrine Entity Stocking Laws in the U.S.
To find more detailed on States legislation for K-12, College, and Public entities FARE website.
Advocating tools for your school are available on the FARE website. Again, know the difference of “Allowed” to “Required” I would suggest looking at the dark blue states and following their laws. We need more blue… to save lives.
Epinephrine Proper Use and Storage
On January 1, 2006, the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) (1) took effect, making it easier for consumers to identify the eight most common food allergens. The FALCPA amended section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343), which is enforced by the Food and Drug Administration (FDA). The FALCPA requires that the labels of all FDA-regulated food products, labeled on or after January 1, 2006, clearly state whether a food or an ingredient found in a food is or contains a “major food allergen.” The FALCPA defines “major food allergen” as one of the following eight foods/food groups or an ingredient that contains protein derived from one of them: milk; eggs; fish (eg, bass, flounder, cod); crustacean shellfish (eg, crab, lobster, shrimp); tree nuts (eg, almonds, pecans, walnuts); wheat; peanuts; and soybeans.
One part of the new Act that seems to have controversy is What is cross-contact?
Cross-contact is the inadvertent introduction of an allergen into a product. It is generally the result of environmental exposure during processing or handling, which may occur when multiple foods are produced in the same facility. It may occur due to use of the same processing line, through the misuse of rework, as the result of ineffective cleaning, or from the generation of dust or aerosols containing an allergen.
During production of pharmaceuticals law REQUIRES to having strong avoidance of cross-contact! So why dont our food? The amount of recalls have been climbing annually.
So many have been working for required regulations but until such, just as you check your daily news or weather report, you must check for recalls, since it is life and death for those facing Anaphylaxis.
To help Americans avoid the health risks posed by food allergens, FDA enforces the Food Allergen Labeling and Consumer Protection Act of 2004 (the Act). The Act applies to the labeling of foods regulated by FDA which includes all foods except poultry, most meats, certain egg products, and most alcoholic beverages which are regulated by other Federal agencies. The Act requires that food labels must clearly identify the food source names of any ingredients that are one of the major food allergens or contain any protein derived from a major food allergen.
- Food Allergen Labeling and Consumer Protection Act of 2004 (Title II of Public Law 108-282)
- Guidance for Industry: A Food Labeling Guide (January 2013)
- Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications (June 2015)
- Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4) (October 2006)
- Food Allergen Labeling and Consumer Protection Act of 2004 Questions and Answers (July 2006)
- Report to the Committee on Health, Education, Labor, and Pensions in United States Senate, and the Committee on Energy and Commerce in United States House of Representatives July 2006 (PDF – 1.8 MB)
- Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling July 2006, Updated April 2013
- Inventory of Petitions Received under 21 U.S.C. 343(w)(6) for Exemptions from Food Allergen Labeling June 2006, Updated April 2013
Do they make drugs on the same lines and are we facing such cross contaminations? Again, no SINCE “required” regulated guidelines by the FDA are law!
“A section within 21 CFR 211 requires drugmakers to institute building and facility controls to prevent cross-contamination of drug products, and the regulation describes the establishment of separate areas for operations as necessary to prevent contamination during manufacturing or processing. In addition, 21 CFR § 211.42(d) requires that operations relating to the manufacture, processing, and packing of penicillin be performed in facilities separate from those used for other drug products. These provisions are similar to those in the ICH Q7 guidance, which recommends dedicated production areas (e.g., facilities, air-handling equipment, or processing equipment) in the production of highly sensitizing materials.”
That is why it is so important to know your “states” legislation and FDA guidelines. Why it is very important to keep in mind to the word “Required” vs. “Allowance”.
If you are attempting to make a change, Please, avoid using allowances and “Require” legislation change.
I see many new parents that have life taking events that get legislation passed easily since they are only asking for “allowance” laws. I have had the door slam in my face since I start off with “require” and if so then regulation is as well required. I do see the need for a lot of change to allowances, still. Baby steps, awareness, and keeping to advocacy in areas we can make differences is our goal, so I will sign and help those that I do see come across my path. I do ask direct questions if they can update to “required”.
Again, I am a grieving mom and not a lawyer, but I have researched areas and read just about everything I can get my hands on. I am a life timer in the Anaphylaxis community. My life into in-depth research started in 2007 when my son was the first diagnosed and I will remain here always. I have grown with the community, have seen many come and go, have cried and shared many joyous moments with millions of you. I remain open from any advocacy group to be universal, to supplying all information, and I talk and attempt to help in any way I can.
Many reach out to me daily. I am a truth seeker, so expect direct feedback from me. I love learning new areas of research so I can share with many that have come to follow Joseph’s Journey. I bought the importance of “TIME” to be the difference between life and death. That was our path to help the next to understand. I speak it daily. Joseph lost his life due to a delay in receiving his auto-injector. I had always given such first and fast and called 911. ALWAYS. A mother’s worst nightmare as I worked hard during a divorce to keeping all to know the severity of his allergies, why I needed to be with him, I fought endlessly.
The last time, he was not in my direct care, due to divorce arrangements and he was placed on his asthma medications a few moments before his auto-injector, 911 was not called, he was then driven to the hospital. Those events and in turn just the period of delay and actions caused his death. They did their best to what they knew. I had always said EPI fast and first, I can only still say such and hope that people understand and listen. That is why I will continue to advocate being prepared and armed with knowledge, with Epi and acting quickly (Epi first and all medication next) call 911. It is the only chance to saving a life.
At one point, I had a family that reached out to me, taken back that they had moved from a “required” school state to an “allowance” both with the 504 laws, but the stocking requirements very different. They had been so angry when they had been called to “pick up” their child until they brought in proper medication. Know the state you are living, just as you decide to move to a state that has a reputable safe crime rate and known good school systems, learn the most important in the lives of those that live with life taking Anaphylaxis.
#BEAWARE #BEPREPARED #ACTFAST #MINUTESMATTER
#BeAware How everyone at any age is at risk of a first-time reaction of Anaphylaxis. Anaphylaxis develops rapidly, usually reaching peak severity within 5 to 30 minutes. Please read about life taking Anaphylaxis it is not just about food.
Anaphylaxis in Pediatric Patients video Study Author: Carla M. Davis, MD
Anaphylaxis in Adults Study Author: Phillip Lieberman, MD
#BePrepared Always go to an Allergist. NOT your pediatrician! If your pediatrician does not refer you to an allergist, get a new pediatrician! NEVER leave without an auto-injector script! If your doctor allows you to walk out the door without such, get a new doctor and report them, bring it into our community social media groups so we are aware of the doctor so others do know. This is a known issue, so no you are not being an alarmist. The industry is aware of the problem and awareness and education is still needed The only chance at life after exposure is to act quickly, with self-administration of TIMELY Auto-injector epinephrine. Carry two always.
#MinutesMatter Never delay the administration of the only life-saving drug. It is the difference between life and death. I CANNOT STRESS THE IMPORTANCE OF HOW TIME IS KEY TO SURVIVAL YOU DO NOT HAVE MUCH TIME.
Call 911 or your Counties emergency departments. It is very important to be monitored since the second reaction can take place hours later. There is no debate to this.
There is no time for the “Not me or my kid” syndrome. YES, you are at risk.
Joseph’s journey continues to save lives daily.
Images are of public domain https://pixabay.com/en/club-auction-law-symbol-judge-2492011/
Source links on Public Web pages found as follows :
Epinephrine Entity Stocking Laws in the U.S. https://www.networkforphl.org/_asset/8483ms/Issue-Brief-Epi-Entity-Stocking.pdf
States laws for K-12, College, and Public entities FARE website: https://www.foodallergy.org/life-with-food-allergies/anaphylaxis/access-to-epinephrine
May Contains’ on Food Labels: What You Need to Know US AND CANADA https://www.allergicliving.com/2014/01/06/may-contains-on-food-labels-what-you-need-to-know/