FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
Filed under: General Problems
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
Posted on April 30, 2025 by Pharmaciststeve
What the DEA and DoJ is doing by controlling the number of opioid “predicted” dosages needed, is not only wrong but ILLEGAL according to another post in this thread. They are NOT medically trained and have red flags on controlled substances that are not paid with insurance, are considered diversion and they reduce the amount of allowable opioid production based on this and many other erroneous factors. They are and should be responsible for the influx of illicit fentanyl allowed into the country – NOT WHAT DOCTORS ARE PRESCRIBING!
The CDC has zero control over what they consider high dosages and were not in their lane when they wrote the 2016 CDC Guidelines for Prescribing Opioids. Addiction is not a contagious disease! Those Guidelines along with the 2022 Revised ones should be tossed since the CDC had no authority to write them.
What has happened to innocent doctors who risk their careers by prescribing opioids, is draconian, cruel, and unnecessary. Our forefathers are rolling in their graves that Asset Forfeiture is allowed BEFORE being found guilty of any crime! How unconstitutional and backward is that?
I see no way out of this unless the DEA and DoJ are reeled back in and an entity has oversight of the DEA/DoJ. They are free to do whatever they want without repercussions for wrongdoing. Also, a group of lawyers should pull out that law stating no Federal Agency can interfere between a doctor and patient [as mentioned in another response] and stop the prosecution of innocent doctors. The DEA needs to be funded like any other agency and remove bonuses for taking down medical providers. Asset Forfeiture should also be thrown out. That was originally created to use against cartels and those dealing with illicit substances, not doctors!
Lastly, why were these forced tapers introduced? Interference from federal agencies in medical treatment. Forced tapers should be illegal except in cases of addiction, not dependence. Reducing opioid use in hospice and palliative care situations is cruel and barbaric, but is happening due to gov’t interference.
The post I referred to several times was written by Pharmacist Steve, a highly knowledgeable, logical, and intelligent individual. He is one of my favorite people I follow! ♥
Again,,none of this would of happen’d if we weren’t forced taper’d in the first place,,,,,As law cfr 42-1395 specifically states,,no interference into medicine,,,,peroid,,So no non medical people make any kind of medical decisions,like kill-ody- n group thinkers,,for the $$$$$$$$$$$$$$$,,When my state official was confronted w.Mr Arein fact that they NO AUTHORITY,,TO INTERPRET THIS LAW,, as the dea has already done,,it stumped him,,,he agreed,,but stated at that time,,the republicans did not carry the house ,,or the senate,,wellll now they doo,,soo if anyone has the $$$$ to fight this,,for the right reason,,its wrong to torture the sick/dieing,and this has got to stop!!!!!!!!!!!!!!!!
no other reason,,,,,u might have a fighting chance,,For if u fight this for personal gain,your no better then kolodyn,,mw
I have a better idea…how about if the DEA and FDA quit messing with all the opioids…quit limiting the ingredients, quit messing around with the ingredients, quit causing shortages and quit causing shortages where the manufacturer won’t tell anyone when they will begin shipping. They are the ones causing everyone to go through withdrawals! They are making it sound like they are doing everyone a favor! They’re NOT. They are inconsiderate who could care less about anyone going through withdrawals. I could write for days on them….grrrrrr
Actually there is a law on the books since 1935 – 35 yrs before the control substance act was signed into law – that suppose to make what they are doing ILLEGAL … but apparently no Fed AG has/had the interest in enforcing it 42 USC 1395: Prohibition against any Federal interference
https://uscode.house.gov/view.xhtml?req=(title:42%20section:1395%20edition:prelim)
From Title 42-THE PUBLIC HEALTH AND WELFARE CHAPTER 7-SOCIAL SECURITY SUBCHAPTER XVIII-HEALTH INSURANCE FOR AGED AND DISABLED
§1395. Prohibition against any Federal interference
Nothing in this sub chapter shall be construed to authorize any Federal officer or employee to exercise any supervision or control over the practice of medicine or the manner in which medical services are provided, or over the selection, tenure, or compensation of any officer or employee of any institution, agency, or person providing health services; or to exercise any supervision or control over the administration or operation of any such institution, agency, or person.
(Aug. 14, 1935, ch. 531, title XVIII, §1801, as added Pub. L. 89–97, title I, §102(a), July 30, 1965, 79 Stat. 291 .)
Statutory Notes and Related Subsidiaries
Short Title
For short title of title I of Pub. L. 89–97, which enacted this subchapter as the “Health Insurance for the Aged Act”, see section 100 of Pub. L. 89–97, set out as a Short Title of 1965 Amendment note under section 1305 of this title.
Protecting and Improving Guaranteed Medicare Benefits
Pub. L. 111–148, title III, §3601, Mar. 23, 2010, 124 Stat. 538 , provided that:
“(a) Protecting Guaranteed Medicare Benefits.-Nothing in the provisions of, or amendments made by, this Act [see Short Title note set out under section 18001 of this title] shall result in a reduction of guaranteed benefits under title XVIII of the Social Security Act [42 U.S.C. 1395 et seq.].
“(b) Ensuring That Medicare Savings Benefit the Medicare Program and Medicare Beneficiaries.-Savings generated for the Medicare program under title XVIII of the Social Security Act under the provisions of, and amendments made by, this Act shall extend the solvency of the Medicare trust funds, reduce Medicare premiums and other cost-sharing for beneficiaries, and improve or expand guaranteed Medicare benefits and protect access to Medicare providers.”
I agree!
They shouldn’t be allowed to manufacture generics with 20% leeway of active ingredients when government is saying Drs can’t prescribe more than 6 pills a day. In 95 I was on 2 pills 4 x day when my tumor grew to the point of spinal compression but I had to wait for my MRI but that didn’t even help the pain at night! Those were brand name. Now they don’t make brand name unless I’m wrong about this.
And how are doctors going to read labels if they don’t see the prescription?
20% leeway is totally unacceptable. Would you want a house built where the builder had a 20% leeway on making sure the structure is solid? It should be 2% at a max. What about generics for heart pts? 20% less of an active ingredient could cause death. Whoever came up with that percentage needs to be flipping burgers instead. Sheesh!
here is from http://www.perplexity.ai: The FDA requirement for the percentage variance of potency in all FDA-approved tablets and capsules is generally that the potency of the active ingredient in the finished dosage form should be within 90% to 110% of the labeled claim. This means the allowable variance is ±10% around the labeled potency. This criterion aligns with the United States Pharmacopeia (USP) standards for content uniformity and assay of active ingredients in solid oral dosage forms.
Key points supporting this include:
– The FDA and USP require that the assay of active pharmaceutical ingredients in tablets and capsules typically fall within 90% to 110% of the label claim to ensure consistent potency and therapeutic effect. This range is standard for most immediate-release solid oral dosage forms unless otherwise justified[1][7].
– Content uniformity testing, which ensures each tablet or capsule contains the intended amount of active ingredient within this range, is a critical quality control measure. The USP Uniformity of Dosage Units sets these limits, and the FDA expects compliance with these specifications during product approval and manufacturing[5][12].
– For batch testing, the FDA guidance suggests sampling a minimum of one-tenth of the production batch or at least 100,000 tablets or capsules, whichever is larger, to assess potency uniformity and ensure the batch meets the specified acceptance criteria[1][17].
– While biological products and complex therapies may have different potency testing requirements tailored to their specific attributes, for conventional solid oral dosage forms like tablets and capsules, the ±10% potency variance is the accepted standard[3].
In summary, the FDA requires that the potency of all approved tablets and capsules be within ±10% of the labeled claim, i.e., 90% to 110% potency, to ensure product quality and therapeutic consistency.
References:
– FDA Guidance for Industry on batch sampling and potency testing[1][17]
– USP Uniformity of Dosage Units as referenced in FDA guidances[5][12]
– FDA Q6A Specifications: Test Procedures and Acceptance Criteria[7]
Citations:
[1] https://www.fda.gov/media/70949/download
[2] https://www.fda.gov/drugs/data-standards-manual-monographs/potency
[3] https://www.fda.gov/files/vaccines,%20blood%20&%20biologics/published/Final-Guidance-for-Industry–Potency-Tests-for-Cellular-and-Gene-Therapy-Products.pdf
[4] https://www.fda.gov/media/115378/download
[5] https://pmc.ncbi.nlm.nih.gov/articles/PMC9961976/
[6] https://www.fda.gov/media/161902/download
[7] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q6a-specifications-test-procedures-and-acceptance-criteria-new-drug-substances-and-new-drug-products
[8] https://www.fda.gov/media/165049/download
[9] https://www.fda.gov/media/87344/download
[10] https://www.fda.gov/drugs/science-and-research-drugs/drug-quality-sampling-and-testing-programs
[11] https://www.fda.gov/media/69957/download
[12] https://www.fda.gov/media/81626/download
[13] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-201
[14] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q7a-good-manufacturing-practice-guidance-active-pharmaceutical-ingredients
[15] https://www.fda.gov/media/71497/download
[16] https://pmc.ncbi.nlm.nih.gov/articles/PMC7513821/
[17] https://www.fda.gov/media/71707/download
[18] https://www.fda.gov/drugs/drug-approvals-and-databases/inactive-ingredients-approved-drug-products-search-frequently-asked-questions
[19] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-1
[20] https://www.drugdiscoverytrends.com/navigating-the-landscape-of-cell-and-gene-therapy-development-insights-from-the-fdas-new-faq/
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Answer from Perplexity: pplx.ai/share