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Continuing this week with our discussion of issues with the North American Menopause Society (NAMS) 2017 Hormone Therapy Position Statement, we will address the topic of "unapproved drugs" and show how most physicians use "unapproved" drugs in their daily practice. The NAMS statement says that prescribers should only consider compounded hormone replacement therapy (HRT) if women cannot tolerate a government-approved therapy (FDA-approved) for reasons such as allergies to ingredients or for a dose or formulation not currently available in government-approved therapies.
The position paper presents the tone that "unapproved drugs" are bad (compounded preparations are "unapproved"). In fact, any modification of a commercial, FDA-approved drug not conforming to the FDA-approved label makes that drug an "unapproved drug." The impression is that all the other manufactured drugs on the market are "approved." NOT SO.
In 1938, Congress passed the FFD&C Act containing a grandfather clause whereby a drug product that was on the market prior to passage of the 1938 act and that contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug application. In other words, they are still "unapproved" (see the Table below).
The FDA has estimated that several thousand unapproved drug products are commercially manufactured and marketed in the U.S. Also, since the FDA considers all compounded preparations as unapproved drugs, this would include:
- all intravenous admixtures in hospitals,
- all in-syringe admixtures,
- pediatric and geriatric oral liquids,
- pain management injections, and
- ALL other compounded preparations.
Also, agencies of the federal government compounding unapproved drugs would have to be included, which involves the following:
- Department of Veterans Affairs,
- Indian Health Service,
- all branches of the armed services, and the
- Federal Bureau of Prisons.
Many state agencies (e.g., hospitals, prisons, welfare programs) and private and public healthcare organizations (e.g., hospitals, clinics) are involved in compounding unapproved drugs.
Regarding veterinary drug products, most commercially manufactured veterinary drug products are not FDA approved.
In addition, nonprescription drug products are not FDA approved but follow the over-the-counter (OTC) monograph system that allows them to be manufactured if they comply with the OTC monographs.
In summary, although partially true, not everything is presented in the 2017 NAMS Position Statement to make it complete and present the entire picture related to "approved" and "unapproved" drugs in the U.S.
Table. Examples of Pre-1938 Drugs on the Market as Unapproved Drugs.
| Acetaminophen, codeine phosphate, and caffeine capsules and tablets | | Opium tincture |
| Amyl nitrate inhalant | | Oxycodone tablets |
| Codeine phosphate injection, oral solution, and tablets | | Oxycodone hydrochloride oral solution |
| Codeine sulfate tablets | | Paregoric |
| Digoxin elixir and tablets | | Phenazopyridine hydrochloride tablets |
| Ephedrine sulfate capsules and injection | | Phenobarbital capsules, elixir, and tablets |
| Ergonovine maleate injection and tablets | | Phenobarbital sodium injection |
| Ergotamine tartrate tablets | | Pilocarpine hydrochloride ophthalmic solution |
| Hydrocodone bitartrate tablets | | Potassium bicarbonate effervescent tablets for oral solution |
| Hydrocodone bitartrate, aspirin, and caffeine tablets | | Potassium chloride oral solution |
| Hydromorphone hydrochloride suppositories | | Potassium gluconate elixir and tablets |
| Levothyroxine sodium for injection | | Potassium iodide oral solution |
| Morphine sulfate oral solution and tablets | | Sodium fluoride oral solution and tablets |
| Nitroglycerin sublingual tablets | | Thyroid tablets |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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Tip of the Week
The FDA requires drug companies to produce tablets within a certain quality tolerance range. However, PBMs/insurance companies are now requiring that patients receive improper and inaccurate doses when tablets cannot be appropriately halved. Does the FDA or state boards of pharmacy not have any authority to require the PBMs/insurance companies to continue the quality-chain through patient administration and dispense/pay for the most appropriate complete dosage form?
A question to ponder is this: "If the pharmacist halved tablets for the patient, that would be compounding, and wouldn't the pharmacist then be required to maintain the required tolerance range?" However, by requiring the patient to do so (and they are generally ill-equipped to do so), it is not compounding and wouldn't the patient, in many cases, receive an incorrect quantity of the drug? The PBMs/insurance companies must stop "practicing medicine and pharmacy" and leave that up to the professionals!
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