Health & Medical Pain Diseases

Federal Regulations for Pain Medications

    Over-the-Counter Pain Relievers

    • Depending on the type of pain medication, federal regulations vary. For over-the-counter medications, such as acetaminophen and non-steroidal anti-inflammatory medications that include ibuprofen and naproxen, the Food and Drug Administration (FDA) regulates the labeling on the medication package. The FDA states that following their approved label regulations for use keeps these pain relievers safe and effective for the consumer. Prescription pain medications, however, are more strictly regulated.

    Narcotic Painkillers

    • Narcotic medications including hydrocodone, oxycodone, and morphine are potent opioid painkillers, and are heavily regulated by the federal government. According to the Drug Enforcement Agency, these medications are termed controlled substances, and require a doctor's prescription manually signed by the prescribing physician or her designated practitioner.

    Refilling Prescription Pain Medications

    • The DEA assigns a different level, or "schedule" to each prescription pain medication, and regulations on refilling these drugs varies according to their schedule. For instance, the synthetic opioid painkiller propoxyphene is a schedule IV controlled substance, and according to the DEA can be refilled up to five times. A more potent pain medication such as aspirin with oxycodone, however, falls under the schedule II category, and requires a new prescription for each refill.

    Filling Prescriptions

    • Prescription pain medications must be filled at a licensed pharmacy, and must include information sheets listing the dosage, side effects, interactions and warnings of the specific medication along with the medication itself. Pharmacists, by federal law, are not allowed to change dosages or medications of prescription pain medications without a consultation with the prescribing physician.


    • Many other things need to be considered regarding federal regulations for pain medications. According to the National Institutes of Health's MedlinePlus website, narcotic painkillers have a high potential to become habit-forming, even abused--which is a primary reason that their federal regulations exist. Another thing to keep in mind is that any pain medication--prescription or otherwise--has the potential for dangerous overdose if taken outside of the FDA-approved regulations for their use.

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