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PSE and Ephedrine Retailer Requirements and Purchase Limits

 


As of July 1, 2011,
Senate Enrolled Act 503 made certain changes to the ephedrine and pseudoephedrine laws in the State of Indiana, specifically to the purchase limits, electronic tracking of drugs purchased, and convenience package storage areas. 

PSE and Ephedrine Purchase Limits (for both regular and convenience package sales)
As of July 1, 2011, the new law changed the ephedrine and pseudoephedrine limits that may be purchased by an individual in the following ways:

  1. A person may not purchase drugs containing more than three and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both, on one (1) day or more than seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, in a thirty (30) day period.  These limits apply to the total amount of base ephedrine and pseudoephedrine contained in the products and not to the overall weight of the products.
  2. A person may not purchase drugs containing more than sixty (60) milligrams of ephedrine or pseudoephedrine, or both, in any one (1) transaction if the drugs are sold in a convenience package. 

Retailer Requirements and Electronic Sales Tracking
As of July 1, 2011, a retailer may sell a nonprescription drug that contains the active ingredient of ephedrine, pseudoephedrine, or both only if the retailer complies with the following conditions (a "retailer" is defined as a grocery store, general merchandise store, drug store, or other similar establishment where PSE or ephedrine products are available for sale):

  1. The retailer does not sell the drug to a person less than eighteen (18) years of age.
  2. The retailer does not sell drugs containing more than three and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both, to one (1) individual on one (1) day, or seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, to one (1) individual in a thirty (30) day period.
  3. The retailer requires:
    1. the purchaser to produce a valid government issued photo identification card showing the date of birth of the person;
    2. the purchaser to sign a written or electronic log attesting to the validity of the information; and
    3. the clerk who is conducting the transaction to initial or electronically record the clerk's identification on the log. Records from the completion of a log must be retained for at least two (2) years. 
  4. The retailer maintains a record of information for each sale of a nonprescription product containing pseudoephedrine or ephedrine. Required information includes:
    1. the name and address of each purchaser;
    2. the type of identification presented;
    3. the governmental entity that issued the identification;
    4. the identification number; and
    5. the ephedrine or pseudoephedrine product purchased, including the number of grams the product contains and the date and time of the transaction.
  5. Beginning January 1, 2012, a retailer shall, except as provided in subdivision (6) listed below, before completing a sale of an over-the-counter product containing pseudoephedrine or ephedrine, electronically submit the required information to the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI), if the NPLEx system is available to retailers in the state without a charge for accessing the system. The retailer may not complete the sale if the system generates a stop sale alert.  (For more information regarding tracking program requirements, please visit our website at http://www.in.gov/pla/3265.htm)
  6. If a retailer selling an over-the-counter product containing ephedrine or pseudoephedrine experiences mechanical or electronic failure of the electronic sales tracking system and is unable to comply with the electronic sales tracking requirement, the retailer shall maintain a written log or an alternative electronic recordkeeping mechanism until the retailer is able to comply with the electronic sales tracking requirement.
  7. The retailer stores the drug behind a counter in an area inaccessible to a customer or in a locked display case that makes the drug unavailable to a customer without the assistance of an employee.
  8. The retailer posts a sign warning that:
    1. it is a criminal offense for a person to purchase drugs containing more than seven and two-tenths (7.2) grams of ephedrine or pseudoephedrine, or both, in a thirty (30) day period;
    2. it is a criminal offense for a person to purchase drugs containing more than three and six-tenths (3.6) grams of ephedrine or pseudoephedrine, or both, on one (1) day; and
    3. depending on the amount of ephedrine or pseudoephedrine contained in the drug, purchasing more than one (1) package of drugs containing ephedrine or pseudoephedrine on one (1) day may be a crime.
The warning sign must list the new maximum amounts of ephedrine or pseudoephedrine that may be purchased in both grams and milligrams.  Please make sure that you have new signage in place reflecting the new limits!

Storage and Sales Area for a Retailer Selling Convenience Packages
As of July 1, 2011, a retailer may not sell drugs containing more than sixty (60) milligrams of ephedrine or pseudoephedrine, or both in any one (1) transaction if the drugs are sold in convenience packages. A retailer who sells convenience packages must secure the convenience packages behind the counter in an area inaccessible to a customer or in a locked display case that makes the drug unavailable to a customer without the assistance of an employee.