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Do You Know Where Your Pills Were Made?

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Q. I am concerned that my prescription pill bottle does not have a country of origin listed on the label. I have lived in Asia where I have seen drug factories. I will never take a generic manufactured there. How can I find out where my medicine is made?

A. Ask the pharmacist the name of the manufacturer. Then you will have to do some homework to find out where the pills originate. About the only way we know of is to search online for the manufacturer to see if you can tell where the drug company is located.

But here is a little-known complication. The raw ingredients (the actual chemical in the medicine, as well as the binders, fillers and colors) may all come from different countries. For example, the API (Active Pharmaceutical Ingredient) may come from a manufacturer in China. The coloring agent may come from a factory in India and the fillers (other inactive ingredients) may come from Thailand. The pills may be assembled and packaged in Brazil. What is the country of origin? Is it China where the API was made, or is it Brazil where the final dosage form is created and stamped?

We agree that country of origin should be on the label, even though that can be confusing. Until the law is changed, however, you won't be able to tell by looking on the label.

It is amazing to us that you can determine at a glance the country where your shirt, pants or shoes are made. Buy fruit in the supermarket and if it comes from another country you will be informed. What's more, if you buy juice, milk or any canned food you will find the identification code and an expiration date somewhere on the label. If the food is spoiled or contaminated, the USDA and the FDA can track it with the lot number on the label.

Look at your generic pill bottle. Go ahead. Take a minute to retrieve any generic pill bottle you might have. Look it over closely. 

It rarely has a manufacturer listed. It rarely has a lot number, so it is impossible to tell when or where it was made or what batch it belonged to. The discard date is almost always one year from the day it was dispended. In other words, there is NO expiration date on the label. The discard date is computer generated and has no relationship with the actual expiration date of your pills.

If you experience a problem with the pills and want to report that concern to the FDA, the agency will ask for the Manufacturer, the Lot number, the NDC number (National Drug Code unique product identifier) and the Expiration date. Here is a link to the "MedWatch Consumer Voluntary Reporting (FORM FDA 3500B) so you can see for yourself. In other words, the FDA requires information from consumers that it is virtually impossible to supply for a generic medication.

We have brought this matter to the attention of the leadership of the FDA and to the leadershp of the National Association of Boards of Pharmacy (that oversees all state boards of pharmacy). Our pleas for action have gone unanswered. It would appear that neither the FDA nor the organization that oversees pharmacy activities care very much about helping patients know the critical details about their medications (manufacturer, lot number, NDC number, expiration date).

If you are as outraged about this as we are, please contact your Senator and Representative. You might also want to let the FDA know this is unacceptable. If the FDA requires patients to supply the name of the drug manufacturer, lot number, NDC number and expiration date in order to file a complaint, then the FDA should require pharmacies to put this information on the label. Otherwise the whole exercise is meaningless, very much like a Catch 22.

While you are at it, why not request that country of origin (where the API comes from and where the pills are assembled) be included on the label as well?

Here are two people at the FDA who hold leadership posts and need to know what real people think about this issue:

Howard.Sklamberg@fda.hhs.gov

Anna.Fine@fda.hhs.gov

 

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I was told by my pharmacy that if there is no country of origin, then it is from the USA. If the product is manufactured in an other country other than the USA, then it is required on the labeling.

PEOPLE'S PHARMACY RESPONSE:

We fear that your pharmacist was misleading you. There is no requirement that country of origin be placed on any prescription pill bottles. And by the way, that also applies to over-the-counter drugs as well. Next time you buy ibuprofen, aspirin or house brand acetaminophen, look to see if you can find a country of origin anywhere on the label. Do not assume such nonprescription products are made in the USA. These days most OTC drugs are made abroad.

If you take a generic prescription medicine of any kind please look it over and let us know if you can find the name of the manufacturer on the label. These days over over 80 percent of the ingredients (active and inactive) originate overseas. That is according to the FDA!

Information about the drugs we take is not available because the drug manufacturers don't want to incur the cost to make that happen. I'm sure they know exactly where every ingredient comes from and could easily provide that information on the label with a few software changes in their computer systems, but they refuse to do so.

Don't expect Congress or the FDA to solve this problem - they are funded in large part by "contributions" from drug manufacturers. All the more reason to use common sense, exercise, diet and supplements with drugs as a last resort.

This burns my backside. I can remember when it was considered a horror if you purchased prescription meds from Canada. And, of course, never buy over the internet - you don't know where the medication comes from. Those concerns are gone now, all for greed. It wasn't enough for Big Pharma that in the US we paid more for the meds that they sold for much less overseas, where they still made a profit. I take many generics, last time I got triamterene HCTZ it came with a label explaining that tho the capsules inside did not all match, it was all the same med. I only take meds that are either life-saving or relieve pain, and, I am very concerned about the quality of the medication. Not only true dose, but other ingredients such as rat feces and insect legs. I will write to the above mentioned people, as well as my congresspeople about this matter. Thanks for bringing it up.

The reader may be quite interested in knowing that most, if not all of, not only generic, but brand name oral tablet and capsule Pharmaceuticals sold in the U.S. today, are manufactured in Countries other than the United States, and have been so for decades.

The largest manufactures of oral medications are foreign based, and as to the question of "inactive components," that question is considered "proprietary" and known possibly, only to the Pharmaceutical Manufacturer of that drug and is subject to change from batch to batch.

I worked with a student who was from a Middle Eastern Country in the 80's who told me at the time, that he had friends who worked at some of those overseas Pharmaceutical Manufacturing facilities and, (according to him), "when they ran out of active ingredient, they never stopped the manufacturing line, but rather just allowed it to run as before.

That statement is emblematic of an ongoing problem that has been consistent with "foreign manufacturing" since at least the 1980's in this country, I should think.

Good luck with trying to report drugs to the FDA. I tried that site 1 1/2 years ago to report the awful reactions I had to Xarelto and it never went through. I tried it three times!

I had severe muscle wasting and excruciating pain. It caused me severe diarrhea and I still have a problem with that almost two years after stopping the blood thinner.

Fortunately my family Dr. is also a Chinese Acupuncturist and was able to get some of my muscle back and that pain relieved.

We are still working on the diarrhea. After reading a post on this site about Metamucil working for a guy's old dog, I tried it and it really does help. I need to take it 2X a day though. It has been a tremendous relief and I do thank you guys for providing this site. In fact I ordered your book for a Christmas present for my son.

Oh yeah! What did I do for the blood thinning since the shots in the belly, Coumadin (rat poison) and Xarelto didn't work? I'm taking Nattokinase, vitamin E, Gingko Biloba and Omega 3s. My blood tests are perfect now!

I have been frustrated also not knowing where my generics originate. Fortunately Walgreens puts the manufacturer on the label, but recently I started going to a smaller, local pharmacy, and they do not.

However, the pharmacist provided me with the manufacturer name when I asked for it. I was relieved to find that my medications are "made in the U.S." but you bring up an aspect I hadn't considered: where are the ingredients from? Merely assembling in the U.S. won't mean a lot if ingredients come from offshore. It's time the FDA stepped up to demand we have this information, and I intend to tell them so. Thanks People's Pharmacy!

We do not have enough FDA inspectors to check foreign or domestic drug manufactures.

If we continue to cut, cut, cut the federal budget in this area, we do so at our own peril.

I couldn't have said it any better, myself!

That's very true.
40 million "Baby Boomers" not withstanding.

Know that just because you're provided with a manufacture's name does necessarily mean that either that manufacturer is domestic or, that the drug is actually manufactured in the United States in any way, shape or, form because, more than likely, it isn't.

Ask your Pharmacist to show you the actual "stock container" if one is available.

The Country of origin should be indicated on the container.

But note that large Pharmacy Chains often warehouse foreign manufactured bulk drugs on a massive level, and then repackage many of their end-line, retail prescription products, so you're not necessarily assured that anything that you're receiving at the consumer level is necessarily manufactured in the U.S., because for purely economic reasons the vast majority of Prescription Drugs dispensed at Pharmacies today are simply, not made in the U.S.A. anymore!

Walgreens, for example just bought out, "Boots Pharmaceutical," a large multi-national global concern which has operations throughout the World, and which has been a key large manufacturer of Prescription Drugs for a very long time.

The prescription that you're getting may be labeled, Walgreens but, particularly if it is a generic product, it's likely manufactured anywhere in the world, other than the U.S.A.

By this recent acquisition of Boots Pharmaceuticals (you can look up that information on the web), Walgreens now has complete access to the absolute cheapest drugs, far cheaper than any other Drug Chain can obtain them either here in the U.S. or, anywhere else in the World, but they still continue to operate on a highly profitable, quite healthy sales margin, as you may have noticed if you ever have to pay cash for a prescription drug with them.

They continue to provide Wall Street with quarter after quarter of very impressive stock returns (with the possible exception of the quarter when they decided to not renew their contract with Express Scripts/Medco, but they've now corrected that mistake).

.....Just saying!

There's a web site drugs.com that has a "pill identifier" page with pictures of all medications, by name. I always check there if the shape, color etc of my prescriptions change on a refill. It tells you what letters, numbers, etc should appear on each side of a pill and who the manufacturer is. That way at least I know if I'm getting the same drug that was prescribed.

In comment 11, the People's Pharmacy requested the commentator to provide information if the name of the manufacturer appears on any generic medication. I take levothyroxine. The label on my prescription bottle says it is manufactured by a company, in India, I believe, by the name of Ranbaxy. Here is a very disturbing video I saw on 60 Minutes which, basically, states that the company has been cited numerous times for manufacturing drugs which have limited, if any, potency.

When I called my pharmacy and told them, they were unaware of this. I mentioned the 60 Minutes segment and said I was reluctant to continue to receive any medication from this company. I was told I could request another manufacturer for my levothyroxine, if there is one.

http://www.cbsnews.com/news/ranbaxy-whistleblower-reveals-how-he-exposed-massive-pharmaceutical-fraud/

Andy, you may be interested in our radio show on pharmaceutical fraud, "Dirty Medicine."

Originally broadcast on July 27, 2013, it's about the Ranbaxy scandal and settlement, and foreign drug manufacturing and oversight.

As you're likely aware,the drug Levothyroxin is what's called a "narrow index drug".

Basically, with the drug Levothyroxin (known also, by several brand names as well as L-Thyroxin) there is an extreme variability of response to the drug itself and, its effectiveness in your body is highly dependent upon the manufacturer's quality control standards for the product.

That said, it doesn't really matter which product that you take, just as long as you're "titrated" (using TSH markers) to that specific product.

The problem lies in that many generic drug companies use outsourced manufactures for many of their product line yet, continue to market those same drugs under their particular company's name.

It would be difficult to know specifically where "Ranbaxy", a large generic manufacturer based out of India actually get their Levothyroxin or, if they actually manufacture the product themselves to consistent standards.

I'm not convinced that many foreign pharmaceutical manufacturers follow the same quality control of standards of manufacturing that are required for U.S. based companies.

The short answer is that you must develop some kind of communication and rapport with the Pharmacists in the Pharmacy that you use.

Often times many large drug chains are so busy that many customers never even get to speak,specifically to an actual Pharmacist or, do so with great difficulty and effort on the part of the customer.

It's not the Pharmacist's fault, but the large drug chains often have their Pharmacists doing a variety of other things at the same time. (although, "patient counseling" is mandatory in all states, as far as I know).

All of that said, as a consumer you must take charge of your own medical therapy and, verify for yourself that, as in your case, "Ranbaxy" (or, any other drug company) is providing to you, the end-line consumer, products that are consistently manufactured from "batch to batch".

Your Pharmacist will be able to tell you, if that is the case, and if you don't "feel the same" after taking a particular prescription medication, you can also, have your Dr. run a "TSH" level and get you "re-titrated" to that particular product, but that's time consuming, requiring a lab test and would do little good if the manufacturer again changes the batch at any time.

It's better if you get to know your Pharmacist well enough to be able to receive the professional service that you deserve as a customer, but you'll have to work at it a little in this era of rapid consumer demands.

Good Luck.

btw: in the case of "Levothyroxin" you can always request "Brand Name" Products and get titrated on that specific product by your healthcare provider, but your insurance (or, your "pocket book") will have to pay out much more for the peace of mind that you'll be getting from using brand names.

Know that there is nothing wrong with generics per se, but product variability is "off the charts" many times in this era of massive globalization of the industry, and levothyroin is a drug that requires a "very delicate balance" in order to get the maximum value from it.

I am an avid fan of Peoples Pharmacy and have been helped many times by this website. Recently, I have started losing my hair. After many doctors and tests, the culprit(s) seems to be Atenolol which I have been taking for 16 years and/or Armour which I have been taking for two years.

So, why should that be happening now? My dermatologist suggested that I ask the pharmacies I deal with, where they purchase their drugs and how often do they change manufacturers. Turns out that CVS switches every THREE MONTHS!, shopping for the "best deals." We, of course, do not benefit from their savings. Publix also shops around but not as often; Walgreens and Wal-Mart have used the same companies for several years. All of this is what I have been told when I called, but of course I have no proof that I was told the truth.

What kind of garbage are we really ingesting? I doubt that Atenolol and Armour are the problem, but rather the fillers and quality of the meds are poisoning me. My husband, like so many other readers, has suffered debilitating muscle pain in his legs and cannot walk, all from taking statins.

So, my question is: how can the American public band together to get an investigation going into FDA activities or lack thereof? FDA is a laughing matter! If everyone reading this sent out a petition to everyone on their email list wherein we demand that President Obama set up a task force to fix this terrible injustice being done to innocent citizens because of the inefficiency of the FDA, maybe we would all start being healthier. Any suggestions?

I don't know the politics behind this nation's prescription drug supply very much, but my suggestion is to try to find a Congressperson from your district who is not associated with the big Pharmaceutical Companies and who shows solidarity with the issue that you raised and maybe, try to start a petition of some kind, as you suggested in your response, in order to put more onus on the FDA to enforce more stringent regulation of this nations Drug Supply.

With Government cutbacks and budget balancing, I'm sure that organization is vastly underfunded, but there are 40 million Baby Boomers in the U.S. and if even a small percentage of us spoke with one voice, it will be heard.

I'm not a member, but AARP or a similar organization might help.

You might also, contact the authors of this website directly,for their suggestions.

They are in a strong position to help,as are national celebrities who focus on the healthcare issues of this country, such as Dr oz.

Other than that, "makes friends" with your Dr. and Pharmacist would be my advice.

The FDA is too busy investigating DNA testing companies who provide a service to regular people, especially those who are interested in genealogy or familial genetic problems. Getting the test directly from 23andme was cheap. Going through the regular medical mill is really expensive and also the info is then in your medical records.

LF, re losing your hair, I experienced the same thing and just assumed it was because I was getting older, but it really freaked me out because the loss was substantial(I'm female). However, when my heart rate dropped too low, my doctor cut my Atenolol dose in half, and my hair not only became full again, it became curly.

Can't figure out the curly, but I assume the hair loss was due to a variation in the medication since I've been on it for decades and never had a hair loss problem. So it's interesting to hear you've had the same issue.

Has our government become so ineffective that they can't even ensure that our medications get the same scrutiny that our canned goods do (with batch, date, etc)...?

The United States is a vast, diverse experiment in Time and, History. To make things better, ya gotta be engaged in the process!

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