Pharmacist FAQsFrequently Asked Questions for Pharmacists on Methamphetamine Act/Pseudoephedrine Products:
-------------------------------------------------------------------------------- Q:What does the Combat Methamphetamine Epidemic Act of 2005 entail? A: Read the guidance document from the DEA Office of Diversion Control. -------------------------------------------------------------------------------- Q: What statutes impact the sale of pseudoephedrine products? The federal statute does not preempt the state statute, so pharmacists must comply with the stricter of the federal and state standards. Click here to read more information on the Methamphetamine Lab Prevention Act of 2005. A: Under the North Carolina statute, “[a]ny pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter.” Pseudoephedrine products “in the form of a liquid, liquid capsule, gel capsule or pediatric product” are not subject to regulation under the North Carolina statute. North Carolina amended its statute to make clear that “such products shall be subject to the requirements of the Combat Methamphetamine Act of 2005.” The federal statute applies to all pseudoephedrine products - including liquids, liquid capsules, gel capsules, and pediatric formulations. The U.S. Attorney General is authorized to exempt pseudoephedrine products by regulation, but no such regulations have been promulgated. -------------------------------------------------------------------------------- Q: How much pseudoephedrine can I sell a customer? A: The North Carolina statute was amended in 2006, and limits a single over-the-counter transaction to no more than two packages containing a combined total of less than 3.6 grams of pseudoephedrine. No person may purchase more than three packages containing a total of more than 9 grams of pseudoephedrine within 30 days. With the amendment, the North Carolina statute conforms with the federal statute, which likewise limits the daily OTC purchase amount to no more than 3.6 grams of pseudoephedrine base, regardless of the number of transactions. The federal statute also limits the 30-day total to nine grams of pseudoephedrine. -------------------------------------------------------------------------------- Q: May I keep track of pseudoephedrine sales in my C-V controlled substances log? To the Board’s knowledge, the N.C. Department of Health & Human Services has not approved any particular form. The Board suggests contacting H&HS for clarification: William Bronson, Program Manager The federal statute requirements for a log book are similar, though the federal statute specifies that the “date and time” of the transaction must be recorded. The federal statute also requires a page-top warning, though, unlike the state statute, this warning must state that purchasers “entering false statements or misrepresentations in the logbook may [be] subject to criminal penalties under section 1001 of title 18, United State Code, which notice specifies the maximum fine and term of imprisonment under such section.” The federal statute provides that the Attorney General shall develop criteria for written or electronic logbooks. No such criteria have been promulgated. Q: Does either the state or federal pseudoephedrine statute apply to hospital pharmacies? Likewise, the federal statute regulates the sale of pseudoephedrine products “at retail,” which is defined as “a sale or purchase for personal use.” Since it is unlikely that a hospital would be considered a “retailer” because hospitals are not normally engaged in the practice of retail sales of medication, the statutes should rarely, if ever, apply to hospital pharmacies.
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