safety concerns

You’ve heard of generic drugs, right? They are kind of like chemical copycats of brand name medicines. There’s Prilosec, which is a brand name heartburn medicine. Then there’s the generic omeprazole. You know Viagra. Sildenafil is the generic. The trouble with generic drugs is that many of the ingredients are now made in China without a lot of FDA oversight. Finished pills are often manufactured in India, Thailand, Slovakia, Brazil, Mexico and goodness knows where else. We have questions about FDA monitoring. That’s why authorized generic drugs intrigue us. Sadly, many health professionals have no idea what they are.

Why Is It So Hard To Get Authorized Generic Drugs?

Q. I want to share my experience trying to purchase an “authorized generic” drug. Our doctor did not know what that phrase meant, nor did any of the pharmacists we talked to.

I found online the label information for the authorized generic and supplied that to CVS. CVS ordered the drug using the NDC code, but that was over a month ago and it is still not in stock.

Walgreen could not find the NDC code in their computer. In the meantime, we had to go ahead and buy the brand-name drug–over $500 for a 30-day supply. Why is this so difficult?

What Are Authorized Generic Drugs?

A. When a brand name medicine loses its patent, the original manufacturer sometimes strikes a deal with a generic drug maker. That allows the generic company to sell the exact same formulation, made from the same “recipe.” Sometimes the authorized generic is made on the same production line as the brand name drug.

As you discovered, most health professionals are unaware of this category. That may be in part because the generic drug industry, pharmacies and the FDA have promoted the idea that generic drugs in general are just as good as their brand name equivalents.

Readers Complain About Regular Generic Drugs:

Jen in Colorado has had generic drug problems:

“I used to be a staunch believer in generics, but that was before I had to take so many medications. I have rheumatoid arthritis and Addison’s disease, and I could open my own pharmacy.

“I too, have experienced severe problems and side effects with generic antidepressants, including lack of efficacy. I have actually gone without an antidepressant for years because my insurance does not want to cover brand name drugs in this class without an act of God.

“I have also run into problems switching between generic manufacturers of prednisone and hypertension medications. When will the FDA force generic manufactures to engage in some sort of trial or research that demonstrates how these drugs compare both to the original, as well as to each other?”

Susie in Indiana had problems with generic Celebrex:

“I just got the generic of Celebrex and thought it would work like the original drug that I used 4 years ago for my back and knee pain. Back then I got instant relief.

“I currently have knee pain and was prescribed the generic. It’s junk, garbage. My knee hurts so badly.

“As of today I went back on Advil, which helps a bit, but not great. I was so looking for much more relief, but the generic just doesn’t cut it. It just doesn’t touch the ache. Once I take it I don’t take anything else for fear of mixing meds. This was a complete waste of money. Hopefully the FDA will recognize it’s not working.”

Marie in Windsor Heights, Iowa also had generic Celebrex problems:

“My insurance plan requires generic substitutes. I couldn’t get the brand Celebrex regardless of my Dr. calling and filing an appeal.

“Taking the generic initially didn’t cause problems but then my mail-order drug company used another manufacturer. I have lupus. The generic celecoxib caused a flare to the point I could barely walk.

“I struggled to get the brand, and finally ordered from Canada. In the USA Celebrex was $1,300.00 for 180 tabs. Canada was $420.00 for 200 tabs. Can’t wait to feel better.”

Joey in New York found generic celecoxib unhelpful but praises authorized generic drugs.

“There is no question that regular generic Celebrex does not work as well. The Greenstone authorized generic is identical to the name brand by Pfizer.

“You can take all the other generic makers of celecoxib and put them in the trash. The real stuff is formulated in a way that delivers the therapeutic dose in the correct manner. The other versions use different ingredients and may only provide 80% of the actual drug, but it’s more the formulation than the amount of drug. That’s what Pfizer put into the R & D and the others just copied but could not make it exactly like Pfizer did.”

Learn More about Authorized Generic Drugs and Online Canadian Pharmacies:

You can learn about problems that have occurred with generic drugs and more details on authorized generics in our Guide to Saving Money on Medicines. This online resource is available at

What’s an NDC Anyway?

The NDC (National Drug Code) is a unique number to identify every drug sold in the U.S. The FDA maintains an online directory of all NDC identifiers.

Share your own experience with generic drugs. Have you ever purchased authorized generic drugs? How did they work? We’d love to hear your story below in the comment section.

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  1. Vikki
    Southern Ca

    I totally agree the information regarding where a medication is made should be printed on the bottle. I discovered by accident that a generic blood pressure med was from China only because the mail order prescription Co. had an extra paper attached as part of the bottle, it was a new color. I refused to take it and called the mo company myself, I told them I refused to injest any medication from China.

    I did have to call around to find where I could get the medication made somewhere other than China. Now, they don’t put that extra tab on the medications and I look it up myself where the mfg. is located. I’m going to hunt around to see if there are any generic brand pharmacys near me.

  2. Ellen

    I am a clinical pharmacist with a doctorate in my field from University of Michigan. I can attest to every one of these issues raised by patients. Authorized generics are certainly one way to go, but often they cannot be “had,” as they are not in anyone’s ordering system. Then there’s the problem with insurance: if the authorized generic is not on the insurance company’s formulary, the insurer will not pay for it. It puts patients in a terrible position. And yes, physicians often do not know the laws regarding generic substitution, and it is an education process. The laws are different in every single state, so there’s a lot of work to do!

    In addition, there are also nurse practitioners and physician assistants who write prescriptions, so more practitioners that must be educated. In the state of Florida, a prescriber must write on the face of the prescription “Medically Necessary” for it to be legal to dispense brand name only. The same dictum applies to electronic prescriptions. Otherwise, the patient is on the hook for the whole amount of the brand medication. Usually quite expensive. Other states, the term “DAW” (dispense as written) must be written legibly on the face of the hard copy of the prescription. Lots of rules/laws that pharmacists must abide by to get a prescription correctly to the patient!!

  3. Sharon
    Lakeland, FL

    About 5 years ago my insurance company decided, without consent from me or my primary care physician, that I would take generic for Diovan HCT. Upon receiving it from my CVS Pharmacy mail order, I called them and asked why it wasn’t the brand. Their response was that the generic was the same as brand and if I preferred brand, my primary care physician would have to request it. Since I was instructed to never skip my blood pressure med or stop taking it, I went ahead and took one of the generic ones. Within 15 minutes I began having terrible chest pains, couldn’t breathe and my arms became immobile and hurt so badly I thought they were falling off! I called my PCP and informed him of what happened and asked that he demand brand, then informed the insurance company and CVS Pharmacy that they nearly killed a good, paying customer!

  4. Pat

    My doctor determined by blood tests that my thyroid levels remained stable only when I took the original drug, Synthroid. Whenever I go to a new pharmacy or go to a hospital for admission, they always say that the only thyroid drug they can get is the generic levothyroxine. They always say Synthroid can be special-ordered but it will take some time to get it. It is always a lot more expensive than the generic pill and not covered by my insurance. Why do they make it so hard to get the drug we need and charge so much for it?

  5. Janet Francis

    I live in Canada.
    Does anyone know if the generic meds here are the same as in the U.S ?
    Thank you!

  6. James
    Bethlehem, PA

    For pain associated with her cancer, my wife was prescribed a Fentanyl patch. These patches did nothing for her pain. Later, I mentioned this to an anesthesiologist who asked if it was a brand-name patch or a generic. Told it was a generic, he said. “Oh, it’s well known that the generics have a delivery problem. For some reason they don’t get the medication into the body.” I have been skeptical of generics ever since. Most are probably fine but some are clearly not.

  7. Hermine
    Columbus OH

    I now use Nature Throid a thyroid medication for hypothyroidism because I use to buy Armour thyroid but they changed their ingredients, probably using fillers that did not agree with me. The fillers are less expensive and manufactured in China where our (FDA) Food and Drug Association is not allowed to enter. I also have to wait several weeks before my pharmacy can fill my prescription for Non-Generic Medrol 4mg dosage. I do not wait until the last minute when ordering prescriptions.

  8. Chris

    Thank you for addressing the problem with generic drugs. We also went through this with my husbands antidepressant generic cymbalta that suddenly stopped working and my daughters seizure medications. I found out that there is no “authorized” generic for them, only unauthorized generics. That means that only the active ingredients have to be the same, the rest do not, including the ones responsible for delivering the drug through your body. If that part of the drug doesn’t work then it doesn’t get distributed and is the same as not taking them at all.

    I’ve also found that the biggest culprits of ineffective drugs are the manufacturers from India and China. The most important information I found is that the FDA has a section on their website where you can report a generic that doesn’t work and they HAVE to investigate any that are reported. It’s a fairly quick process- it took me less than 5 minutes. They are not going to change anything unless we all flood them with complaints. And it’s true, the doctors do not know these things but my pharmacist did.

  9. Betty
    Missouri City, Tx

    I was taking Celebrex when the generic formulation came out and, of course, my insurance company switched me to the generic. I have had numerous back surgeries and Celebrex was the only thing that actually helped the pain without causing extreme gastro distress. The generic did nothing. It was useless. Then I read about Authorize Generics on your website. When I took my Rx to CVS, I requested Greenstone. They had to order it for me but it made such a difference! Like others, I was to the point that I was willing to pay out of pocket for the brand name Celebrex just to have some relief. Thanks to People’s Pharmacy and Authorized Generics, I didn’t have to do that.

    • Vikki

      Thank you for the information about how CVS ordered your meds from Greenstone. I take Metformin and I’m going to see if they will do that for me because it caused me intestinal pain with diarrhea several times a day until I stopped taking it.

  10. Robin

    I can’t take synthroid, so I’ve been on Levoxyl for years. Recently I’ve been getting sick — dizzy, jittery, heat palpitations — and I couldn’t figure out what was causing it. Then I went from hypo to hyerthyroid, and developed hypertension.

    When I talked to my pharmacist, I discovered I’d been taking the generic of Levoxyl — which is levothyroxine: levothyroxine is also the generic for the brand, Synthroid.

    Then my pharmacist informed me that the only way I could get the real Levoxyl is if my doctor stipulated it, in writing, on every prescription she wrote for me for Levoxyl. If she didn’t do that, I’d get the generic levothyroxine because it’s the law — they HAVE to fill the prescription with the generic no matter what the prescription says unless otherwise stipulated.

    So I talked to my rheumatologist about it, and she said “Don’t worry, I’ll just write in your records that you have to be given Levoxyl.” So I told her: “IT HAS TO BE WRITTEN ON THE PRESCRIPTION or they’ll give me levothyroxine. She then told me to “just tell the pharmacist” that you need Levoxyl. I was amazed. My Doctor doesn’t even understand this law! I’m still not sure she gets it.

    I’ve been seeing people with thyroid issues all over the internet talking about how their Levoxyl medication “isn’t working anymore,” and they’re having to go on Armour instead. Now I know why.

  11. Nancy

    I use various generics due to non coverage of name brands by insurance. I have a corn allergy and have a lot of trouble finding generics that don’t have corn or it’s by products in the inactive ingredients. The large chain pharmacies don’t even keep the prescribing info from the drug manufacturer to be able to check inactive.

    Anything you buy in a store has to disclose all ingredients and yet pharmacies don’t check ingredients for allergies. If they do have the detailed prescribing info sheet, I have to show them where to look for the inactive ingredients.

    Something is wrong with this process.

  12. Joy Matson

    I would like to know what you think and know about generic thyroid medicine. I have been on thyroid replacement for many years and some of them generic. My doctor said I needed to take the brand name, but I have always wondered why.

  13. Lily

    When it comes to using generic medicines it really is a case of trial and error. I lived in Ireland most of my life and always was prescribed Branded drugs I actually had never heard of Generic medicines until I moved to the UK and boy did I have problems! At first, I thought I was ill and I seemed to spend half my life in the Drs and what really annoyed me was they never said it was the tablets! Anyhow I started to notice I felt better some months and not so good others it then dawned on me it was the different generic drugs so I made a note of the ones with the least side effects and also the ones that delivered the best results and now I stick to these although it is a nightmare every time I need a new medicine as I have to start all over again . Personally, I believe these substandard drugs should be banned! It is an utter disgrace that some Governments allow them to be sold and do not give a care about the suffering and pain people go through. Do not let anyone tell you they are the same! basically a branded drug delivees 100% of the medicine but generic drugs can deliver anything between 80% & 110% and in my case it was happening with Beta Blockers to control my heart rte so some months it was too fast and other months too slow and this was having a dreadful effect on my general health also generic drugs have a lot of cheap inactive ingredients in them usually they are bright red/green or blue with E nos that are banded in most parts of the civilised Worldto make matters worse in the UK all medical care is free including the drugs and you have to accept what you are given unless you go to one of the few private Drs and pay and they will prescribe whatever drug you need,.

  14. ChrisofDan
    Asheville, NC

    This is appalling. Why is our government not taking more care of the prescription drugs that they are supposed to be overseeing for safety’s sake for the citizenry. The fact that a lot of these generic drugs are made in other countries where there hardly seems any oversight and are allowed to be distributed by our pharmacies is a disgusting tribute to our dysfunctional medical community. Doctors know nothing, drug companies plead unaware or just don’t care, insurance companies force us to take drugs (unchecked chemicals, placebos, or whatever) that don’t work, government does nothing. The fact that some have to go to Canada for the right to a name brand drug so they can feel better…..that is not allowed by the autocratic insurance companies….is shocking. These ineffective drugs need to be removed, the companies that make them should be punished.

    • Maria

      So true. I have been taking generic medication for years and am still in poor health.

  15. Jan

    I take Klonipin for seizures. The name brand is very expensive and hard to find. The generic does not work. The pharmacies in Canada can not fill this prescription. I would like to know about authorized generics. It would be helpful if pharmacies would give this information

  16. Bobby

    I wish we could get a list of common generic drugs that have ingredients from or are made in countries like China. It should be our right to know where the chemicals we are ingesting come from.

    • tomcat

      What I do is to google the vendor’s name to find out if it is an Indian pharmaceutical company or a front company. What I determine is a “front company” is one that establishes a finishing site (encapsulating or tablet pressing) here in the US, but uses the bulk ingredients from India—Aurobindo is one example. I have a list of approximately 10 Indian pharmaceutical companies, including Aurobindo, that I will not use. As an example, about 3 years ago, I noticed that my montelukast (for allergy) was no longer working as well. I checked the bottle and discovered that 3 weeks earlier the pharmacy had switched from Roxane to Aurobindo without my approval. I immediately switched back to Roxane and still continue to specify that brand. Walgreen’s has been great at ordering my meds for me from reputable US manufacturers.

    • gary

      IMO, there is a certain level of paranoia and/or snobbishness among american’s and their fear of generic drugs made in other countries. I reside in Costa Rica. I have purchased and continue to use various generic drugs made in India, Mexico, etc. All these plain generic medications deliver the same results as the name brand I used. Companies that produce generic medications in other countries may not have the FDA to answer to but they have governments that imprison company owners, managers, and board members for selling fake medications. That kind of government response seems to provide more incentive to produce good valid medications than some fine the FDA may impose in the US.

    • Belle

      It should absolutely be possible to easily find out where a drug is produced. I don’t understand why there are standards for drugs and other products produced in the US but US companies don’t require foreign companies to adhere to those standards when they make products for sale in the US. If you look on labels, it will say something like “produced for distribution ” for such and such company, but not where it is produced/made. Why can’t the wording be required to be “produced in China for distribution by such and such company”?

      • Joe Graedon


        We do find it surprising that your clothing will have a tag that says where it is manufactured. Ditto for shoes and many other items. NOT for pharmaceuticals. Seems like people should let Congress know it would be good for the public to have access to this information.

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