The FDA issues lists of essential drugs and critical materials to be purchased from U.S. plants

The U.S. FDA released a List of Essential Medicines, Medical Countermeasures, and Critical Materials on October 30.
was issued in accordance with the requirements of an executive order "Buy American" signed by U.S. President Donald Trump on August 6.
the executive order is to direct the federal government to purchase more essential drugs from U.S.-based pharmaceutical plants.
Order of August 6 requires federal agencies to limit purchases of products "made in the United States" to "the maximum extent permitted."
"Production in the United States" requires "critical materials for the production of essential drugs or medical countermeasures" to be produced in the United States, including the core chemical composition of APIs and preparations.
addition, finished preparations or finished equipment are required to be "produced, prepared, nurtured, prepared or processed in the United States".
the past few weeks, the FDA has said it has developed a list of 223 essential drugs and medical treatments for biologics, in consultation with other federal partners.
also includes 96 medical countermeasures for devices.
these devices include diagnostic test boxes and consumables for rapid detection and treatment, personal protective equipment, active vital signs monitoring equipment, vaccine delivery devices, and equipment for the management of acute diseases, such as ventilators.
According to the list, the 223 essential drugs are classified by different therapeutic uses, including: aspirin, inoparin (where key substances include API, heparin, crude heparin), heparin (key materials include API and crude heparin); helamin; atropine, ammonia chlorodipine, hydrochloroquine, nitroquine, nitrate glycerin; artemisinin; azithromycin, ampicillin, cephalosporine , cephalosporine, clintycin, datomycin, strong mycomycin, fluorine Conazole, LOX, methotrexate, penicillin G, Lifuping, vancomycin, methamphetamine/sulfonamide methylazole; fluorosterol, otoxypine; acetaminophen, ibuprofen; canine, fentanyl, morphine, Leigh Dokain/adrenaline; axilove, osetavet; salbutamol; glyphosate; insulin glycerine, regular insulin; dexamisone, hydrocodone, methyl permatin; left thyroxine; epinephrine; immunoglobulin ....
detailed list can be accessed by logging into the forest.
FDA says essential drugs typically identified by the FDA are the drugs most needed by patients in U.S. emergency care facilities and are specifically designed for short-term treatment of serious injuries or illnesses and emergency medical conditions.
The medical response identified by the FDA is a product regulated by the FDA that meets the definition of "medical countermeasures" provided in the executive order (biological products, drugs, and devices) and is required by the FDA to anticipate future pandemics, epidemics, and chemical, biological, and radiological/nuclear threats.
FDA notes that "in determining essential medicines and medical responses, the focus is on covering those medicines that are medically necessary in order to have an adequate supply that can be used in the widest possible population, with the greatest potential impact on public health."
" and key materials include essential medicines and API for medical countermeasures, as well as ingredients or compositions with unique attributes that are critical to evaluating the safety and effectiveness of such products.
, the FDA said in a statement, "The adoption of innovative technologies such as advanced manufacturing technologies can enable the U.S. pharmaceutical industry to increase its competitiveness with foreign companies and help ensure a stable supply of drugs critical to the health of U.S. patients."
"for companies that want to add products to their lists made in the U.S., the FDA encourages them to consider advanced manufacturing technologies."
executive order also directs the FDA to coordinate with federal agencies on a number of other issues, including strategies for purchasing products on the list, accelerating domestic production in the United States, and identifying and addressing supply chain vulnerabilities.
According to the executive order, federal agencies should then limit the purchase of the listed products to domestic sources in the United States, and for each product on the list, the purchase order should be specified as being available to at least two manufacturers in the United States to ensure competition.
federal agencies will have 90 days to develop procurement strategies, including long-term procurement contracts.
U.S. drug supply chain's over-reliance on foreign companies and the pharmaceutical industry's return to the U.S. has been the focus of discussion in recent years, exacerbated by the COVID-19 pandemic.
series of U.S. government actions this year are trying to solve this additional problem.
May, Phlow received a $354 million contract from BARDA for domestic generic and API production and established the Strategic API Reserve (SAPIR).
the end of July, the U.S. government announced a $765 million government loan grant for Kodak to produce API and intermediates in the United States.
addition , in July , the U.S. government reserve began bidding for critical API in response to future pandemics or national emergencies .
How the executive order will be implemented, how these essential drugs and apidials and intermediates will be moved back to the United States for production in a short period of time, and how the U.S. election in a week's time will affect the implementation of the executive order remains to be known."
although there is still a lot of uncertainty about the executive order , the intention of american medicines to cut off the supply of drugs from China is clearly on the table , and in any case our exporters should prepare early .
know the forest - pepper