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Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Methamphetamine Act/Pseudoephedrine Products:


Q: When does H12 (Session Law 2011-240) - electronic tracking of pseudoephedrine sales - take effect? Where can I find more information about this and what is required?

A: The statute is effective January 1, 2012.

For more information:

  • October 27, 2011 letter to Pharmacy Managers from NC SBI Director Gregory S. McLeod outlining the new legal requirements enacted as a result of Session Law 2011-240. (CLICK HERE TO READ THE LETTER.)
  • Click here to read Session Law 2011-240 House Bill 12: http://www.ncga.state.nc.us/enactedlegislation/sessionlaws/pdf/2011-2012/sl2011-240.pdf
  • November 16, 2011 follow-up letter to Pharmacy Managers from NC SBI Director Gregory S. McLeod that includes NPLEx account login, training, and support instructions and information. (CLICK HERE TO READ THE LETTER.)
  • To avoid double record keeping, the North Carolina Mental Health Commission has deemed reporting into the NPLEX system as a "form approved by the commission," thus eliminating the requirement for keeping two logs and obtaining two signatures.   By reporting in to the NPLEX system, NPLEX is essentially keeping your log for you and electronically storing it. Law enforcement may retrieve the information from NPLEX.  If the system is down or you are for some reason unable to use it you are then required to keep the log and obtain the signature are previously required.
  • A pharmacy must still post a sign visible in 10 point bold face print near the place where the  electronic signature is obtained that says the following:

    "NORTH CAROLINA LAW STRICTLY PROHIBITS THE PURCHASE OF MORE THAN TWO PACKAGES OF CERTAIN PRODUCTS CONTAINING PSEUDOEPHEDRINE (3.6 GRAMS TOTAL) PER DAY, AND MORE THAN THREE PACKAGES (9 GRAMS TOTAL) OF CERTAIN PRODUCTS CONTAINING PSEUDOEPHEDRINE WITHIN A 30‑DAY PERIOD. BY MY SIGNATURE, I ATTEST THAT THE INFORMATION I HAVE PROVIDED IN CONNECTION WITH THIS TRANSACTION IS TRUE AND CORRECT AND THAT THIS TRANSACTION DOES NOT EXCEED THE PURCHASE RESTRICTIONS. I ACKNOWLEDGE THAT KNOWING AND WILLFUL VIOLATION OF THE PURCHASE RESTRICTIONS OR THE FURNISHING OF FALSE INFORMATION IN CONNECTION THEREWITH MAY SUBJECT ME TO CRIMINAL PENALTIES."

    This should be called to the customers' attention at the time the signature is obtained.
  • The PSE restrictions apply only to the retail sales of ephedrine and pseudoephedrine products sold behind a pharmacy counter and do not apply to valid prescriptions dispensed to a consumer.

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Link to DEA Q&A on the Combat Meth Act of 2005: http://www.deadiversion.usdoj.gov/meth/q_a.htm

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Q: What does the Combat Methamphetamine Epidemic Act of 2005 entail?

A: Read the guidance document from the DEA Office of Diversion Control.

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Q: What are the new training and training log requirements for the sale of pseudoephedrine products in NC?

A: Please click here to read a memo from the NC DHHS Commission for Mental Health, Developmental Disabilities and Substance Abuse Services.

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Q: What pseudoephedrine products are subject to the statute?

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.

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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.

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Q: May I keep track of pseudoephedrine sales in my C-V controlled substances log?

A: The North Carolina statute requires that retailers record “the name and address of every purchaser,” “each pseudoephedrine product purchased, including the number of grams the product contains,” and the “date of the transaction.” This recording is to be “on a form approved by the Commission.” The form “shall be constructed so that it allows for entry of information in electronic format, including electronic signature” and “so as to minimize the disclosure of personal information to unauthorized persons.” Each page of the form must contain a 10-point boldface warning prescribed by the statute.

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
Drug Control Unit, NC Department of Health & Human Services
Phone: (919) 733-1765
william.bronson@ncmail.net

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.

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Q: Does either the state or federal pseudoephedrine statute apply to hospital pharmacies?

A: The North Carolina statute imposes limitations on the “retail sale” of pseudoephedrine products and upon “retailers.” The Act defines a retailer as “an entity that is the general owner of an establishment where pseudoephedrine products are available for sale.”

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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