Recent reports of various products made in China being contaminated made me wonder: If I buy clothing or food, it is generally labelled with the country of origin. How can I find similar information for prescription medicine? By the time I get the drugs, they are in the pharmacist’s packaging. I tried looking at the web sites for the manufacturers of my own daily meds, and could not find anything.
Is it possible that nobody at all knows? Or knows how to find out? Weird.
Call me crazy, but I would think the one person who would know is the pharmacist who fills your prescription.
If contamination is found in a particular package of medicine, the authorities and the manufacturer will want to be able to trace the contamination to its source. So my guess is that they can do so, using the lot number on the packaging. My further guess is that a package of medicine may contain ingredients from multiple countries, which is why they don’t label any particular package.
I happen to have a prescription medicine in a sealed manufacturer bottle, and just checked. It does not have any country of origin listed, although the lot number was specified.
Last year a TV show says they are manufactured in 65 countries.
That’s what I was afraid of. So, basically, if CompanyA imports an ingredient (active or inactive) from some country that is not as careful as it should be, and some nasty thing or other is in there, we have no way of knowing unless there is some reported incident. Nice.
I would imagine that if a noticeable number of people had the same adverse reaction AND it could be traced to the same batch of CompanyA product, then there would be the usual hoopla. Otherwise, we could be ingesting Og knows what, trusting that CompanyA has sufficient quality control measures in place.
Even if an final active pharmaceutical ingredient is made in a particular country, the intermediate chemical feedstock that the drug was made from could be coming from anywhere (says the person who used to work in fine chemical pharmaceutical intermediates). Fortunately the FDA maintains very stringent quality control on drugs that should (in theory) detect any noncompliant batches long before they reach your neighborhood pharmacist. (which is why we dealt mostly in intermediates - the hard core QC and FDA scrutiny was on the end product, although specifications for intermediates were squeaky tight)
For more reading on how your pharmaceuticals are made, see CGMP.
Thanks, Solfy. How about the inactive ingredients? What I worry about is things like the melamine (or whatever that was) that got into pet food and other products because of an unethical supplier. How hard would it be for such substances to get into the fillers, etc. that make up the bulk of the pill? Wouldn’t it be awfully tempting for a manufacturer to use a cheaper substitute?
Ordinarily, you could ask the pharmacy where it was filled. They’d at least be able to tell you who made it if your prescription vial doesn’t have that information. From there, you could probably find out where it was made.
Many of the stock bottles in my pharmacy do not have a location of manufacture on them. IMO they should – my grocery store can’t legally sell fish and produce without tracking and displaying where they came from, but we can sell various poisons without having to do the same.
Thanks, Bambi. That’s what bothers me. I’m glad that, as Solfy said, there are copious rules about drug manufacture, just like there are rules about food safety. And there are dishonest and unethical people in every country. However, we did not get melamine-laced dog food ingredients from Japan, or Canada, or Germany. We got it from China. Given my druthers, I’d prefer not to ingest substances manufactured there.
If I were to contact a pharmaceutical company and ask this question, do you think they’d answer me? How does that work?
As I understand it, and someone further along the drug manufacturing line feel free to correct me, but the FDA is also assuring the compliance and purity of all of the inert ingredients in medications. It would be foolish for them to test only the API and not the actual pill that is going to consumers, because the binders and additives can have an effect on the drug. Consider extended-release medications for example: the rate of release must be controlled and consistent from pill to pill. They also must prove that the pills are shelf stable within their expected lifetime, etc. The binders and fillers can affect those aspects.
I’m pondering how far you’d get asking the pharmaceutical company directly. You’d need the lot number of the drug, which you could get from the pharmacist, and while many bits of pharmaceutical manufacturing are carefully guarded proprietary secrets, I’d like to believe there has to be some degree of transparency.
The reason I wouldn’t be concerned is that in comparing dog food manufacture to pharmaceutical manufacture, you’re comparing apples to oranges. Drug manufacture is tightly regulated, tightly overseen, with disastrous consequences for tampering, both in potential personal damage and/or loss of life, but also in negative publicity and revenue loss for the manufacturer. I don’t mean to sound jaded, but it does boil down to the bottom line. The risk is too great for the potential benefit of saving a few cents on what is already an inexpensive commodity (fillers, binder, etc.) especially in relation to the API (very expensive to manufacture fancy molecules). Animal feed is a cheap commodity, and the people that altered the food probably counted on either the problem not being traceable or the ease of starting business back up under another name when caught.
In my experience, the label of origin is normally written even on the stock bottle of the medication, or in the patient information guide that is stuck to the bottle. Now, these are things that normally the end patient do not see, so if you really want to know, ask your pharmacy to look at the stock bottle, or the paper that comes stuck to, or in the bottle.
The only manufacturer I know off hand, Generic maker Teva Pharmaceuticals, has their drugs produced in Israel.
I don’t know that they would be able to answer you, at least not while you waited on the phone.
I happen to design industrial controls for a living, and a lot of our customers are pharmaceutical plants. While I don’t know the details of their business, I do know that they have to keep a LOT of records. You can take the lot number off of the bottle and trace it back to where every single ingredient came from, and any anomalies (even ones that aren’t supposed to be significant) that occurred at any stage during the manufacturing process.
The thing is though that all of these records aren’t in a handy dandy cross referenced global database that you can query with ease and have all kinds of info pop out at you. If there’s a problem (especially one that might involve lawsuits) the pharmaceutical company won’t mind having a few dozen people pull together all of the records for a particular lot, but I can’t picture them doing this for some Joe who just happens to call on the phone.
All verrry interesting. And logical. And somewhat reassuring.
Thanks to everyone. I knew I’d find an answer here!
It’s still odd IMHO that clothing carries a label saying where it was made, and not drugs. Aside from the safety issue, if I wanted to avoid buying products of any kind from a particular country for whatever reason, there is no way to know in this case. But that’s a separate issue.
However, this year has already seen several recalls from Ethex, including propafenone, morphine, dextroamphetamine, isosorbide, and hydromorphone, all for being oversized and therefore delivering more medication than intended.
Other common manufacturers include Ranbaxy, Glenmark, Dr Reddy, Ethex, Caraco, Westward, Mallinckrodt, Apotex, Mylan, Barr, InterPharm, Sandoz, Watson, Qualitest, and Actavis.
Thorough Googling and research might help reveal where these companies make their products, but most of their websites don’t have their manufacturing locations prominently displayed. Ordinarily, I’d assume that’s because they don’t really want you to think about where specifically your medications are coming from.
Do you know where Ethex has its manufacturing facilities?
Apologies for the long post to follow…
The reason why they don’t bother putting a manufacturing country on the bottle is that they would have to list several countries for each product. Each ingredient can come from a different supplier - it is quite common to have the pill made by X company in Canada but with API made by Y bulk manufacturer in the US while the lactose comes from A in India, the magnesium sulfate from B in China, etc.
I very much doubt any pharmaceutical company would reveal this information to you without a court order. Most companies will have their plants listed on their “Contact Us” pages, so you can at least know where that company makes things, but that doesn’t tell you anything about their suppliers.
That being said, I can pretty much tell you that each and every ingredient is tested, certified and traceable, as is the intermediate stuff like the chemicals needed to test the ingredient, the calibration of instruments used, the employees who did the testing/handled the product, etc. It is all traceable, and is, in fact, how the FDA and equivalents can recall specific lots of drugs when a problem occurs.
I used to work as an analytical chemist in the pharmaceutical industry in Canada, and this is a general description of how things worked from the point of view of the final manufacturer (which I’ll call FM). I’m going to refer to pills, but this would be true of capsules, gel-caps, creams, ointments, opththalmics, injectables, shampoos, gels, suppositories, etc.
Inactive Raw Materials: FM identifies a supplier of inactives (excipients) and sends people over to basically do a quality audit to ensure that the product and facilities meet FDA standards (and/or standards for other countries in which they want to market the pills). Each and every bulk barrel of material has it’s own lot number/bulk ID and can be traced back to it’s source. Either the FM or the supplier will conduct the Quality Control testing on each lot of bulk material, making sure that it has no impurities and that it meets all other specifications (water, Loss on Drying, microbio). A certificate of analysis (C of A) is issued and the FM can begin to use the bulk product. Usually, IME, the supplier is validated by the FM so that the FM’s employees don’t have to do any additional testing and they can just take the barrel and the C of A and start manufacturing.
Active Pharmaceutical Ingredients (API or Drug Product): Like with excipients, the supplier is audited and validated. If the FM is the manufacturer of the API, then they also need to do a full range of testing and have everything traceable back to the source and issue a C of A and approval for use. IME, the FM would receive the barrel of API with the supplier’s C of A, but would still conduct an in-house testing plan to verify at least appearance, potency and impurities and often Water Content (Karl Fischer) or Loss on Drying criteria and microbiological content. Once the in-house C of A is issued, the barrel can be used to manufacture as many lots as it lasts for (one barrel of any ingredient does not equal one manufacturing lot, btw, and one lot might have material from more than one barrel if one does not contain enough material!)
If the FM needs to change suppliers of any ingredient, they need to show that the new supplier is providing a product that is essentially identical to that of the old one, and that the pills manufactured are the same, etc. There is a very tedious validation process to go through, and so FMs like to keep the same suppliers forever!
Final Product: Quality control for final products is rigid as well. A typical testing process for a lot of pills might be as follows;
The pills are made, and an amount of pills are taken from the barrel and bottled/labeled by hand and sent to the testing lab. The bottle is logged in by lot number or an in-house Lab ID, and all testing done is associated directly to that ID. One or more chemists will be assigned to test the pills and once all tests are completed, reviewed, approved and the C of A is filled out, the lot can be released for packaging. The pills are then packaged into the bottles and boxes that the pharmacists/customers see, and then a given amount of those boxes are pulled for testing (ID and stability). In the lab, the chemist will test ID (which is basically a potency test, to make sure that the bottle that says 5mg has the 5mg pill in it of the right type, and not some other strength/pill) and once that is completed, reviewed, approved, and the C of A is signed off, the lot can be shipped to pharmacies. The manufacturer knows which lots got sent to which client, to make recalls a lot easier.
I have posted about some of this stuff before (especially stability programs) so search under my name and you should be able to find more info.
General tests conducted on products:
Pills (pre-packaging):
Potency
Impurities
Appearance
Average Weight
Size
Dissolution
Water Content
(Post Packaging)
ID
Appearance
Stability:
Potency
Impurities
Appearance
Dissolution
Water Content
Injectables and other liquids would be tested for pH and possibly viscosity, specific gravity and UV spectrum as an ID, as well as Volume or Fill Weight of the bottles.
Suppositories would also be tested for melting point (often 32-36 degrees Celsius)
Capsules would have fill weight of individual capsules verified to make sure they were filled correctly.
There is so much more I can write about, but basically that’s the kind of testing and tracking that happens. At my first job, our data reviewers were constantly reminding us that “If it isn’t written down, you didn’t do it” no matter what the flasks and vials on your bench indicated (yes, I had to re-do a test once because I forgot to write down something!)
Feel free to ask more questions - I’ll address anything I might know. I hope that was informative - sorry for the rambling style!
No, and damned if I can find it online. I looked at some of the product inserts available on their website and all they say is “Manufactured by KV Pharmaceuticals for Ethex.” KV is Ethex’s parent corporation, and they’re both based in St Louis. Looking at their job openings, they have quite a few manufacturing and manufacturing-related positions available on their website and they are all for St Louis. I’d find it reasonable to conclude that they assemble the final product in the United States.
However, as mnemosyne so expertly lays out, they aren’t made top-to-bottom in any one plant as a rule. Pharma manufacturing is a global business, with components for each coming from all over the world.
Interesting side note for KV: on 12/11 they fired their CEO (he claims he retired) and then on 12/19 they stopped all shipments of all tablets of the drugs they manufacture so that they can address the problems that have lead to all six of their recalls this year.
that was great!
Thanks