a boy holding his hand over his mouth because he said something he shouldn't have

The Food and Drug Administration’s announcement last week that two generic Concerta formulations might not work as well as the brand name medication has rekindled questions about the FDA’s generic drug approval process.

The long-acting generics are made by Mallinckrodt and Kudco. According to the FDA, the generic drugs delivered the active medicine methylphenidate at a slower rate than the brand name Concerta. This could have important implications for patients.

The mainstream media did not perceive the story as very exciting or worthy of the public’s attention. And yet this generic drug alert is likely to have far-reaching consequences for the generic drug industry.

The History of Methylphenidate

Concerta is the brand name for a stimulant drug called methylphenidate.

Methylpehnidate was originally approved by the FDA under the brand name Ritalin in 1955 for treating hyperactivity, what later became known as ADHD (attention deficit hyperactivity disorder). The problem with Ritalin was that the original formulation was relatively short acting. This meant that the benefits of the drug wore off after three to five hours. Doctors often prescribed two to three pills a day to be taken before meals.

This was inconvenient, especially for kids in school. Slow-release (SR) and long-acting (LA) formations were created, but each had some drawbacks. Ultimately, an extended-release formulation was created that provided a controlled rate of medicine for a long period of time.

OROS, a Unique Controlled-Release Delivery System

Concerta, an extended-release formulation of methylphenidate, got the green light from the FDA for ADHD in 2000. It was designed to provide active medication for 12 hours. The formulation was unique in that it used the OROS delivery system.

OROS stands for Osmotic [controlled] Release Oral System. It is a sophisticated gradual-release system that works because of a laser hole in the tablet. As the drug moves through the digestive tract, water enters the permeable membrane surrounding the tablet. The pressure created by the added water gradually pushes the active drug out through the laser hole.

Concerta lost its patent in 2011.

Generic formulations of extended-release methylphenidate ER could not use the OROS system because it was a patented process, although an authorized generic sold by Actavis apparently uses the identical OROS delivery system.

Authorized Generics

Authorized generics are licensed from the brand name manufacturer. They use identical active and inactive ingredients and are often made on the same production line as the brand name medication. They use the same formulation and delivery system as the branded product.

Other generic manufacturers have to come up with their own formulation that will, in theory, mimic the brand name process of releasing the active drug into the body. We have learned that is not always the case.

The Budeprion XL 300 Boondoggle

Early in 2007 we detected a problem with the generic version of the antidepressant Wellbutrin XL 300. The generic formulation, Budeprion XL 300, contained the active drug bupropion. The chemical was the same but the formulation was quite different. Wellbutrin XL 300 used a  membrane technology to get the drug into the body. The generic used a maxtrix technology, which released the medication substantially faster than the brand name.

Hundreds of visitors to this website reported side effects with the generic that they never had with the brand name. They also noted that the generic did not relieve their depression adequately. We badgered the FDA for years about its approval of the generic formulation. Eventually, the FDA conducted its own tests and agreed that the generic was not bioequivalent to the brand name and had Budeprion XL 300 removed from the market in October, 2012.

The Generic Concerta Controversy

Generic manufacturers of extended-release methylphenidate needed to develop their own special technology to produce a long-acting 12-hour effect. They couldn’t duplicate the OROS delivery system. Physicians, pharmacists, insurance companies and patients assumed they had been successful because their products passed the FDA’s bioequivalence testing standards. But then came reports of problems.

“To me the biggest fraud is when generic companies are allowed to change the dispersal method of a pill and still call them equivalent. This was the problem with generic Wellbutrin XL. I noticed almost immediately that the Teva generic [Budeprion XL 300] just didn’t work.

“I’m having the same problem with my husband’s Concerta ER. He noticed the problem the very first day. He said ‘it’s not as bad as taking nothing but it’s not nearly as good either.’ The first generic was actually a re-branding of the brand name, which was fantastic for us. But now, other companies have developed methylphenidate ER pills. The dispersal method is different on the new ones. They don’t have the same coating! Again!

“I fail to see how these can be considered equivalent. If they’re going to make a methylphenidate extended release with a different dispersal method they should be required to NOT call it generic for Concerta ER. And since I’ve learned from the Wellbutrin fiasco, I have called all over again looking for the original ‘generic.’ One pharmacy in the area carries it, because it’s more expensive to stock. I bet everyone is surprised by that, huh?

“My main point is that it took me a lot of phone calls and a lot of experience to figure this stuff out. How can we possibly expect everyone to be able to do what I managed to? Seniors who are starting to have memory problems? People who just plain don’t know it’s a possible problem? People with three jobs who don’t have the time to call 8 different pharmacies every time they get a refill?

“It’s disgusting, and I personally find it reprehensible that we allow the race to the bottom price to have priority over people’s welfare.” C.M.

The Bottom Line

The FDA has now acknowledged that its approval process for the extended-release form of generic Concerta was, in essence, flawed. The agency apparently received a number of complaints, just as we did. Additional analysis and laboratory tests convinced the FDA it had a problem, which is why it issued the “concern” about the Mallinkrodt and Kudco generic methylphenidate products. The Actavis authorized generic is made by the brand name manufacturer of Concerta and is, in fact, bioequivalent.

What are we to make of this entire mess? For us, the issue goes far beyond Budeprion XL 300 or generic forms of Concerta. The rules and regulations that the FDA relied upon for decades to approve long-acting generic formulations was, in our opinion, flawed. It did not take into account hour-to-hour blood levels but lumped everything together into something called the AUC (area under the curve). This allowed the FDA to approve generic drugs that actually performed quite differently from the brand name product they were supposed to be mimicking.

Although the FDA has maintained for years that generic drugs are “identical” to their brand name counterparts, that is clearly not the case. And the FDA seems to be gradually acknowledging that. The agency has  revised its rules regarding generic approval of extended-release preparations. We think our visitors are partially responsible for this change. The only problem is that hundreds of older timed-release generic products remain on the market. They were approved under the old “guidance.” We just do not know how well they are working or if they would pass muster under the new regulations.

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  1. Helen
    WEST VIRGINIA
    Reply

    I have had trouble with 3 different generic drugs. My life has been completely changed because of them. Severe anxiety and I never had anxiety before. Suicidal Thoughts, cognitive decline, derealization. Started waking up in the morning in a severe panic . A lot of people become scared to be alone and very very fearful . Also causes stomach upset, diarrhea, loss of appetite I couldn’t stop losing weight lost a total of 70 pounds . It’s been seven and a half years of pure hell. The first drug was the generic Lamictal. Second one was generic Effexor and third one was generic Wellbutrin. I know it’s not the way my body reacts to this medicine because brand name was completely different.

    I saw this happen to many people when I was administrator in an Effexor withdrawal group on Facebook. I believe it’s something in the fillers or binders that might be affecting the way that the medicine releases.

    I believe if these medications had been working right I would not be in the mess I’ve been in and lived in this suicidal state for 7 years. Once this happens to you it’s like you become extremely sensitive to the medication. I believe the burning in your head is inflammation and that it does something to affect your blood brain barrier. I don’t know what it’s going to take for people to realize that this is happening. All my doctor would tell me was to up the dose I’m glad I didn’t.

  2. Brian
    Pennsylvania
    Reply

    I have noticed a similar problem regarding generic Adderall XR. The biggest difference I noted happened when I was given the generic Adderall XR manufactured by Actavis.

    I haven’t heard or read anything regarding this specific medication. In my experience, Actavis has been a quality producer of generic “equivalents” for the most part. I hope that this is eventually addressed, and doesn’t become a trend with Actavis.

  3. MO
    burlington
    Reply

    I have 2 boys who have been taking the off brand of Concerta with no problems for the past 5 years. This February I went like usual to our Family Doctor with my boys for their regular required Monthly exam to take any ADHD meds. Like usual they signed the printed prescription which I took to CVS like I had done every month for the past 5 years.

    With no warning from my doctor or the FDA that same prescription went from the regular $10 copay for a total of $20 to a total of $90. It has gone up several times since. I have tried other ADHD meds for the boys which has been a ridiculous roller coaster for them and their health! I have switch to other pharmacies where at the first visit I save $5 or so, only for them to go up the next visit for refills on exact same prescription.

    So with a doctors visit each month and a ridiculous increase on meds for my boys on a verrrrrry tight budget, I can’t hardly afford gas and groceries even with 2 jobs. I, myself, am supposed to be on Adderal but I can’t afford my meds and theirs and yes I have insurance which I pay dearly for. If it’s against the law to gouge on gas prices and such, how can it not be against the law to gouge on medicines???????????

    Why isn’t their anything that can be done for soooo many of us that are struggling with this???????????????? And I mean, REALLY DONE??????? I am brought to tears from the frustration and the Nation wonders why people going crazy. We are fed up with being taken advantage of by mega medical companies, the FDA, the Government and the frauds who work for them all!! Their hearts aren’t for the good of the people, their hearts are only for getting the peoples money! Our Nation is no longer free!????! It is enslaved to the greed to be gained off the sweat and hard work of others! Forget the little people keeping up with the Jones’, we are just trying to keep our families fed and well educated!!!!!

    • Steve
      Ohio
      Reply

      MO, I could not agree more about the Concerta. My son has been taking it for over a year now with little to no side effects. However, with my fantastic insurance, it’s $308 a month for 30 pills. We just had him switched to generic Adderall IR, only due to the price. He had been on Adderall XR in the past but, we believe it was the time release delivery method that caused him some issues…mood being one of them.

      So with 2 doses a day, one at home and one at school, we will see. If you can’t afford it, you can’t afford it. We have 2 kids, live in a 2 bedroom home, I’m an IT Manager and my wife is unfortunately disabled. WE DO NOT live a lavish lifestyle. We can only afford to go on vacation every 3 years…I know, some can’t afford to go on vacation ever, and I get that. Apparently I make too much, according to Johnson & Johnson. So now I am seeking a new job with better benefits, or at least one that will give me a $3,700 raise, which is what his meds run a year.

  4. Sue
    new York
    Reply

    I have been taking Dexedrine Spanules same dosage for 15 years. This med is just as effective as other stimulants for treating ADD as any of the other forms including Ritalin, adderal, etc.
    It’s generic form is D-amphetamine ER… Last year CVS began using Avista brand d-amphetamine Extended release…. IT was seriously SUBSTANDARD, it’s Biovailability was incredibly much much lower than ALL other generic forms of this med. CVS should remove it from inventory at once…. do you think Tylenol waited for the government to tell them to take their product OFF their shelves after their product killed people?????? CVS, have you no conscience?

    • Bill
      Florida
      Reply

      Just outright greed. There is no free enterprise in drug products. It will only get worse with the wealthiest people running the country. It’s all about money and control. Where is a Robin Hood of the 21st century! NOT in the Republican or Democrat parties.

  5. Walt
    panama city beach fl
    Reply

    Ya, this is the reason generic concerts cost over $100 to 150 month for 30 tablets. For a generic drug this is way too expensive for people to afford out of pocket, if they don’t have insurance.

    And disbursement method, that is crazy, take different doses. This is a big crock. When people can’t afford this.

    • Grand
      VA
      Reply

      My son was just prescribed the Concerta. NONE of the pharmacies around my city carry the Concerta brand drug; they only carry the generic. The problem is, my insurance will not cover the generic ($285/ 30 pills), while they WILL cover the Concerta brand ($30/ 30 pills). I just had to have the neighborhood pharmacy order it for me. It should arrive sometime next week. In the meantime, summer school starts on Monday for my son (he failed 5 classes this year, and his doctor, after having seen him for 8 months, JUST diagnosed him as having ADHD this afternoon). Hopefully, the Concerta will help him.

      • Phyllis
        Nam
        Reply

        What is your insurance company? $30 for 30 pills is a Godsend,
        Each time we go to get a refill the price has gone up……a lot! Last price was $220 for the malinkrodt pills!!
        There has got to be a way!!!

  6. Kathy
    Raleigh, NC
    Reply

    I want to know why the FDA didn’t give notice to the patient’s taking this medication. Even with getting my prescription through mail order process, this generic/concerta has stalled my medication. I was informed of this problem by the pharmacy and not my doctor. The government does make you feel like a criminal even with a written script. Now I am forced to investigate all the other medications out there and hope that something will work.

  7. Laraine
    Providence Ut
    Reply

    I wish that FDA would advise the consumers when they change a generic form of concerta (methylphenidate ) ER my son has ADHD and ODD and needs both this and Intuniv to help control it I was in shock when I took the prescription in went to pick it up and was told even with insurance I was going to pay 107.14 a 92.14 increase I didn’t get it because the price it high now I’m left to try find other avenues to help my son

    • Bill Logan
      United States
      Reply

      I have insurance but must pay retail price before I meet deductible.
      The 90 days supply for 2 a day is $1040 through Express Scripts.
      This is a rip off for a generic drug.

      • Stephen
        Philadelphia
        Reply

        Better yet, I received a notice from Express Scripts yesterday informing me that methylphenidate is no longer covered in their formulary. The message went on to vaguely tell me it might be possible to get an exemption or to get it pre-certified or to switch to something similar. Each of the above was in language that conflicted with the others. I am about to call to get this clarified but Express Scripts is a master of confusion and double talk, with the ability to talk forever at you without ever answering any questions. Just what is the alternative to methylphenidate? I can’t replace it with Adderall as I am already taking that. This information coming just after the doctor visit means another unnecessary and very expensive visit to the doctor, which is not covered by insurance.

        • Cathy
          FL
          Reply

          Express Scripts thru Medicare are a bunch of liars , I have severe central origin Hypersomnia Narcolepsy/Cataplexy and was a RN in Maine but the incompetent doctors would sometimes refuse to treat me due to fear of addiction, They all knew the multiple auto accidents totaling 2 brand new cars! but would say “be careful driving”

          I also as do majority of Narcoleptics have ADD or ADHD. I take Dexedrine 10mg 6 cap day and I still fall asleep , well Express scripts sent me a Mfg: Mayne Pharma caps generic which do not work and act like a placebo they charged me $ 400 for 30 day supply (186 caps) when I only make $900/month SSDI, I always got 90 day supply generic Dexedrine and asked for Mallinkot brand , They called me and said ” Florida new pharmacy laws prohibits giving count 2 drugs more than a 30 day supply”

          I told my doctor and she was as mad as a wet hen and wondered what they are doing with the remaining of the 540 she prescribed? I spent 2 days calling FL board Pharmacy to get to the bottom of this and guess what! EXPRESS SCRIPTS LIED” so I called express scripts and told them they were wrong , well now the story changed ” TEIR 4 dugs only allow 30 day supply count 2″ I said you people can not even get your story straight as you told me one lie after another and sent me that Mayne generic and charged me $400 for 30 days and my doctor wants to know where are the remaining 540 caps she ordered.

          I am sick of the pharmacies controlling valid RX , doctors associations doing not a damn thing about it, and the DEA and FDA are as corrupt and have no business in delivery of health care. I am sick of it as I worked sioionce age 14 and was forced out of a profession I loved due to ignorant doctors.

  8. Aurora D
    Reply

    Because of a “new law” I could not get the generic concerta and had to pay about $165 for my monthly prescription. The generic and the brand name look exactly the same!! Every time I go to any pharmacy to get my medicine, I am treated like I am asking for an illegal substance.

  9. Karen
    Illinois
    Reply

    BC/BS of IL will be requiring Prior Authorization for Concerta prescriptions beginning April 1st. If authorization is denied the patient will be on their own for the full cost of Concerta with zero insurance benefits. Yikes! That will cost me over $12,000 per year for my three kids! Major red-flag here is that BCBS of IL has no protocol in place to approve or deny prior authorization of Concerta! So, you can bet the plan is to deny all submissions. Come April 1st the window to change insurance providers will no longer be opened, therefore I will begin shopping for a replacement insurance plan today. Bye bye Blue Cross Blue Shield!

  10. BG
    Reply

    While this announcement has it’s good points, it also now it seems, has a real downside for users. As of January 1, many formularies dropped this as a generic an stated that even the Actavis generic was being considered a brand. The net effect for many will be a large increase in co-pays. I have been told that Actavis did this because it had not competitors so it raised its prices. Wondering if anyone else has seen this happen.

    • Maryann
      Hamilton, NJ
      Reply

      My son has been on generic Concerta for years and we have had no issues. Now because of this ruling, instead of paying $5 for his prescription, we are now paying $87 (copay). All of the generics are now considered a brand and this has cost us close to $1,000 a year that we don’t have. We have tried all of the other ADHD meds out there and nothing else works so we are screwed! In addition, he takes Abilify for which there is no generic. We had to take the hit of $100/month for that not too long ago but another $80/month hit is killing us. I just wonder how many other people this is effecting vs. the initial battle that was fought against the generics. I don’t know about anyone else but this victory for some was just the opposite for us and we have nowhere to turn.

      • Susan
        NY
        Reply

        Abilify went generic April, 15 2015.

    • Paula
      Texas
      Reply

      Yes, just tried to fill son’s RX and found they are considering the one generic a brand name, made from the same company as concerta. Calling back the doctor to try something else. I’m guessing that Actavis was very happy with the FDA ruling. Hopefully we will find something else that will work besides Concerta.

  11. Chris
    Massachusetts
    Reply

    I’m glad the FDA finally came around to looking at this more closely. As soon as I was switched from brand name Concerta to generic, I noticed that the pills are less effective in the morning, and I had greater difficulty getting to sleep at night. At the time my doctor didn’t make any changes. Now with the release of this new information from the FDA, he is going to specify the Jannsen generic no substitution, and if that’s unavailable, then Concerta no substitution.
    A drug using a different dispersal method is not and cannot be a direct substitute, you would think by definition. Seeming equality under carefully controlled tests with carefully worded goals of equivalency don’t mean they work exactly the same inside people’s bodies. If they don’t exactly copy the dispersal method it is a _new drug_ and should be treated as such by the FDA. This incident and the Wellbutrin incident should make it clear that it is medically unsound, even reckless, for the FDA to approve as generics any drugs which aren’t literally the same as the brand-name original in terms of formulation including dispersal method and inert ingredients.

  12. Denise
    Massachusetts
    Reply

    Today I found out about this when dropping off the written prescription I just picked up from dr at CVS. They refused to fill it cause it had both names on the script. – I had to go back, of course dr is out today and bring back script to be changed. Tomorrow morning I am going to call insurance company to find out what they will be requiring – other generic or will Concerta be placed on cheaper list. Then I will have to worry about what the pharmacy will carry. Merry Christmas!

    • lynda
      georgia
      Reply

      Well Chris, I am so happy that you are glad that the FDA did this with concerta. Now this prescription went up 5.3 times what it had originally cost before.

  13. Gina Pera
    California
    Reply

    Thank you for sharing this news with your readers.

    Giving credit where it is due, I have been covering this topic for more than a year, at my blog, http://ADHDRollerCoaster.org.

    And so has pediatrician Kristen Stuppy, at her blog.

    Following my advice, my blog’s readers have filed complaints with the FDA’s Medwatch (after we succeeded in getting these generics on Medwatch).

    In short, this didn’t come about on its own.

    Through my blog, many people discovered why their Concerta was no longer working–despite assurances from their pharmacists that it was “just the same as brand!” Many physicians hadn’t a clue.

    Consumers must remain vigilant. They must check their prescription each month, to see if there are change. And, unfortunately, they must understand that a profit-making pharmacy is not the best source of information on “bioequivalence.”

    It is worthwhile reading the comments to my various blog posts on this topic, to see the very real human fall-out to these cynical plays by generic makers.

    http://adhdrollercoaster.org/the-basics/we-did-it-concertas-generics-on-fda-watch-list/#.VGwGSIeKTqU

    • The People's Pharmacy
      Reply

      Indeed. consumers sharing their experience and filing complaints with MedWatch make a big difference. Thank you.

  14. Sam
    NC
    Reply

    I was on Concerta and had to stop because it made me sick and I would not sleep for days. The generic was Watson and I thought they were reliable. Reading this I notice they are not mentioned and I am curious if anyone knows if the same holds true for Watson generic Concerta as well.

    • Gina
      California
      Reply

      Hi there,

      The Watson product is the EXACT SAME as brand. It is simply sold as a generic thanks to a marketing agreement struck by Watson (now Actavis) and Janssen (maker of Concerta).

      If the Watson product didn’t agree with you, it might be because this type of medication, in this delivery system, is not a good fit.

      Fortunately, there are many other options for people with ADHD, including two classes of stimulant (MPH and AMP) and many delivery systems (pills, pump, patch, etc.)

      Good luck!
      g

    • Mineola
      USA
      Reply

      Watson was purchased by Activis

  15. Lisa
    Buffalo
    Reply

    I was just started on Budeprion XL 150mg which is generic. My psychiatrist is intending to increase me to Budeprion XL 300mg soon. I am uncertain from this article now whether that will or will not be generic and if so whether I should be alarmed.

  16. Neil K.
    Ripley, Tn.
    Reply

    It’s amazing just how many doctors and pharmacists are unaware of the FDA’s bio-equivalency requirement. I have had both doctors and pharmacists tell me that generics have to be the same by law because the FDA requires it. At that point I explain how, because of patent laws and proprietary formulae, they can’t be the same. Then, figuring that if the doctor or pharmacist in question is to uninformed to know any of this, they are probably not the people I wish to entrust with my health and I go elsewhere.

    Also, for the uninformed, a trip to the FDA website to learn what bio-equivalent means can be an eye opener. I highly recommend taking the time to do so. You will refuse generics after reading that.

  17. Neil K.
    Ripley, Tn.
    Reply

    It’s amazing just how many doctors and pharmacists are unaware of the FDA’s bio-equivalency requirement. I have had both doctors and pharmacists tell me that generics have to be the same by law because the FDA requires it. At that point I explain how, because of patent laws and proprietary formulae, they can’t be the same. Then, figuring that if the doctor of pharmacist in question is to uninformed to know any of this, they are probably not the people I wish to entrust with my health and I go elsewhere.

    Also, for the uninformed, a trip to the FDA website to learn what bio-equivalent means can be an eye opener. I highly recommend taking the time to do so. You will refuse generics after reading that.

  18. Matt Mullen
    Reply

    Finally, thanks to the Peoples Pharmacy and their readers, it looks like the FDA is finally “getting a genetic clue”.

  19. Sandy M
    Dallas, Texas
    Reply

    I was told about the problems with generic medications in the 90s. When it comes to mental health, we shouldn’t play around with medication. I think I was told that a generic medication had a 20% leeway so it could have either 20% more or 20% less. On top of that, here are some other problems with generics.

  20. Steve
    Baltimore
    Reply

    This is especially true of Antiepileptic drugs. Google “american neurological association generic drugs”. Numerous articles citing problems including from The Lancet, NIH, American Academy of Neurology, etc.

  21. LL
    Reply

    This story made my day! Our prescription insurance is going to essentially a generic only pricing system that will make the cost of Concerta go up hundreds of dollars a month for us starting in January.

    I was planning to do anything possible to keep my high school son on the brand and didn’t know how I could fight the change to generic since it became available last year. It looks like the FDA is doing the leg work for me…such wonderful news.

    I hadn’t heard this anywhere else so thank you so much Graedons!

    • Joe Graedon
      Reply

      LL, thank you for this message. You may now have some ammunition to use with the insurance company. The Actavis generic form of Concerta is an authorized generic and may solve your problem since it should be identical to Concerta.

      • Gina
        California
        Reply

        Hi Joe,

        The problem now is that, with the two cheap generics off the market, Actavis seems to have raised its prices and insurance companies have adjusted their formularies to exclude it.

        For example, one woman who used to pay $10 per Rx at their local pharmacy for the Actavis generic is now paying $100. She is complaining to BSBC but so far, they are not being responsive. Perhaps if enough consumers complain.

        Insurers should educate themselves on the long-term health-costs and risks of poorly managed ADHD. Excluding one of the most efficacious ADHD Rx options is penny-wise and pound-foolish.

        If your readers would like some guidance on how to deal with this fluctuating situation, I’ve done my best to provide it here: http://adhdrollercoaster.org

        Thanks,
        Gina

        • Steve
          Reply

          Hello Gina,

          The FDA assigns generics an AB or BX rating. BX is inferior regarding “Bio-equivalence”. However, the FDA ALLOWS BX rated generics to be sold. I had complained to my pharmacy (Rite Aid) regarding Mallinckrodt’s BX rated version and they are now only carrying the Actavis generic. Mallinckrodt is still appealing their downgrade and the FDA’s CDER requested on Wednesday that the “March 20, 2017 date be suspended without a new date being set at this time. Incredible!

      • Walt
        Reply

        That’s why the price is so high. This exclusive agreement. $100 or more per month for 30 tablets. What do they think they are selling anyways. Pay cash out of pocket for that every month.

  22. Shirley Orf
    Saint Louis
    Reply

    I have read that coconut oil is a “carrier.” Has there been any research to determine if coconut oil carries turmeric and/or black pepper into the blood stream? If so, do I need to combine them before ingesting?

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