Dear Dr. XXX,
On August 22nd 2014, the Food and Drug Administration (FDA) announced stricter regulations and controls for Hydrocodone-Containing Products (HCP). Examples of hydrocodone-containing products are Norco, Vicodin, Lortab, Hycodan, Tussionex and several generics. These new laws will take effect on October 6th 2014 and means that all prescriptions for Hydrocodone-Containing Products will have to be written on state-approved prescription pads. State approved prescription pads for schedule II substances can usually be obtained from individual state’s Department of Public Safety.
How does this affect you?
- Prescriptions with refills for a HCP written before October 6th 2014 will still be valid up until April 8th 2014 or 6 months from the date on the prescription, whichever comes sooner.
- Patients’ requiring prescriptions for HCP from October 6th 2014 will have to contact their physicians’ offices for new prescriptions written on the state approved prescription pads.
- Prescriptions for the reclassified HCP are usually not allowed by state and federal laws to “called-in” (verbal) or faxed to the pharmacy from the physician’s office except in emergency situations as defined by federal law. Reminder: prescriptions for Schedule II controlled substances must be written in ink or indelible pencil or typewritten and must be signed manually by the practitioner. Signature stamps are not legal.
- Nurse practitioners and physician assistants can no longer write prescriptions for HCP when they are reclassified schedule II controlled substances.
- Starting from October 6th 2014, new prescriptions for HCP will be valid for only specific period of time as determined by individual state laws. For the state of Texas, the validity of Schedule II prescriptions is 30 days.
- The refilling of a prescription for a controlled substance listed in schedule II is prohibited by law.
- Federal law prohibits prescribers from pre-signing prescriptions (21 CFR, Section 1306.05).
- The practice whereby the physician pre-signs prescriptions and Nurse Practitioners write in the medication, route, dosage, and amount is illegal. Do not do either of these things and do not post-date a prescription. If you need to provide a prescription for November’s dose of a schedule II controlled substance in October, date the prescription for the day you write the prescription and write “Dispense after November 1, 2014.”
Do not hesitate to contact me at ____ (insert your telephone number) should you have questions or would like more information about this matter.
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