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Washington News: New Pseudoephedrine (and Other Precursor Drug) Restrictions
Published in the July 2006 Washington State Board of Pharmacy Newsletter
On March 6, 2006, the USA Patriot Act reauthorization bill was enacted. This bill included new federal requirements intended to combat the production and distribution of methamphetamine. The Board has received many questions regarding this act, specifically, the effect that these new regulations have on recently implemented state regulations.
The Board staff has reviewed both documents and has produced the summary below. It is important to note that the following reflects our understanding of the current combined federal and state regulations. This summary should only be used to assess compliance with the Board of Pharmacy. Note: PPE def. – a product containing pseudoephedrine, phenylpropanolamine, or ephedrine.
Effective April 7, 2006
Package Requirements: All non-liquid products (including gelcaps) must be in blister packs. Each blister pack cannot contain more than two dosage units. Sales Limits for the Retailer: Single retail transactions are limited to no more than two packages regardless of package size. Each package cannot contain more than 3 grams of the restricted ingredient. But, the total transaction cannot exceed 3.6 grams by federal law. This may essentially limit most sales to only one package. These limits do not include PPE obtained by a prescription. Purchase Limits for the Consumer: It is unlawful for the consumer to either purchase more than two packages of PPE products in 24 hours or purchase a single package containing more than 3 grams of PPE product or purchase more than 3.6 grams of PPE products per 24 hours or purchase more than 9 grams of PPE products in 30 days (7.5 grams may be obtained by mail or private carrier). Mail order: The seller needs to first identify the purchaser using procedures established by the attorney general (federal). A mail-order vendor cannot sell more than 7.5 grams of PPE products in a 30-day period per customer.
Effective September 30, 2006
Product Placement: All products must be kept in a central location that cannot be accessed by customers. This includes products previously exempted by state law: liquids, gel capsules, and liquid capsules. Transaction Log: Customer must present an acceptable government identification (ID). Information that needs to be logged includes: date and time of purchase, name, address, and signature of purchaser, type of ID, number on ID, name of product, and the number of packages and the number of dosage units. With only a few exceptions, all products need to be entered in the log. A statement must also be included on the log that warns purchasers about the criminal penalties associated with making false statements or misrepresentation. Log Retention and Destruction: The seller must keep the transaction log for two years. When destroyed, the log must be unidentifiable and non-retrievable. Release of Log Information: Licensed retailers releasing information relating to the sale of PPE products in good faith to state, federal, orlocal law enforcement agencies will be immune from civil liability. Training Requirements: Training of personnel that assist in any transaction involving PPE products must occur. Licensed retailers must submit to the United States attorney general certification that such training has occurred and that all employees understand the requirements of the law.
