DrugBuyers.Com: Roxicodone quality

Your single question actually asks several. With specific regard to Roxicodone, all Roxicodone tablets are manufactured by Roxane Labs. Its active ingredient is Oxycodone, the same narcotic analgesic found in OxyIR, OxyContin, Percodan, and Percocet. Oxycodone is a specific chemical compound for which there is no variation from manufacturer to manufacturer. Roxane has several Rox products, like Roxicet, which is the equivalent of Percocet (Oxycodone/APAP), which is their way of creating some sort of unique brand identity for its generic products (kind of like Bubblicious, I suppose) It is possible for manufacturer's to change their medication's color, markings, or imprint codes, which occurs only rarely and usually when there has been a significant number dispensing errors specifically resulting from one unit dose appearing very similar to another. It happens rarely, because changing them involves a very expensive process of revising reference, marketing, and clinical materials, and may further confuse visual identifications among those who have become familiar with its original presentation. There is, however, no standard which mandates that the same drug, by the same manufacturer must appear in the same presentation among different countries. In fact, Purdue Pharma has just changed their Mexian OxyContin presentation to assist U.S. law enforcement in determining the source of illicit OxyContin distributed on the street. Upjohn released their hair-growth product as Regaine around the world, but modified it to Rogaine in the U.S., as it was determined that a name resembling "Re-Gain" implied guaranteed results. The reasons are wide and varied.

The FDA requires that the active ingredient in approved generic equivalents be identical, but each may chose its own inactive ingredients, such as coatings, binding and stabilization agents, and flavoring, provided they do not distinguishably alter its therapeutic efficacy. It must deliver an equivalent dose with equivalent absorption and metabolic rates and several other pharmacologic properties such as half-life, potentiality until expiration among others.

Does this mean that all generics are made equal? IMO, yes, they are wholly interchangeable. Many claim that one brand may be more potent or otherwise different than other, but there is no scientific or medical data to support these opinions to anywhere near the extent they seem to appear. On the other hand, DNA and the human genome are wonderfully complex, and I think it would be absolutely foolish to state unequivocally that there has been no real difference to any human anywhere at any time. Im sure that an individual somewhere may have a sensitivity to coloring or a binding agent that ultimately has affected the medications overall efficacy, but the standards to which the FDA requires the formulations to be equivalent would make these cases very, very, (did I say very?) rare.

At the very same time, however, I will state without doubt or hesitation that the very same hot dog unquestionably tastes different, and better, in the bleacher seats at a baseball game than it does anywhere else. Im actually being quite serious; perception is an essential component of reality, and the placebo effect has been proven to be as strong as the most potent narcotic. Nevertheless, I personally would have no basis for alleging or supporting a claim that one generic is generally stronger, better, or more effective than any another. (Note, I am referring only to U.S. manufactured and distributed prescription medications)

On a related note, there is no evidence that one generic manufacturer uses generally inferior ingredients than any other, or they are inferior to even their brand equivalents. FDA guidelines still apply to all of the medications, which ensure a baseline measure of quality and parity among all drugs, brand and generic alike. Generic firms medications are not less expensive because of less expensive ingredients or less sophisticated or expert processes. On the contrary, they are highly skilled chemists and manufacturing professionals. Their medications are less expensive because, unlike brand drug manufacturers, they have absolutely no Research, and almost as little Development cost to recoup, and their business models dont even have to account for that risk, which is why the brand manufacturers demand such a premium for their products (reward has to reflect the investment risk) as these expenses can comprise some 40% of their overall budgets. It is a HUGE expense and risk, as is the liability risk from potential patient liability lawsuits which are all but nonexistent by the time a patent expires and a generic version comes to market. From day one, generic manufacturers focus is on solely recovering their ingredient, production, and distribution costs alone. In fact, many use the very same materials and processing as the branded item. In some cases, they will actually contract with the original manufacturer to produce the medication if their facilities have excess capacity.

To risk such a lucrative business on an inferior ingredient or process (which may save a fraction of a single percentage point of manufacturing costs) simply wouldnt pay off. At the same time, there is no assurance that brand manufacturers hold themselves to a higher production standard, as evidenced by Schering-Ploughs $500 million in fines stemming from its quality control problems at its Puerto Rico production facility. They are entirely different businesses, and the cost difference is NO indicator of quality.

As for the variation among your specific tablets, it is entirely possible that they are from different lots that were handled differently at some point throughout their distribution cycle. One may have been stored inappropriately in excessive heat or humidity, hastening their breakdown; its just impossible to tell. In general however, at the point of manufacture, and as an industry, both brand and generics manufacturing standards are identical or comparable.

Additionally, there is no regulation preventing a pharmacy from accepting medications back from you and issuing a refund, but this would be solely as a customer service gesture. They are not permitted to exchange medications without treating them as entirely new prescription, subject to all applicable provisions, guidelines, and applicable regulations. Once they prescription leaves their custody, they can not conclusively guarantee that they are actually receiving the same medication in kind.

I hope this helps!