Included in the following article is information that was updated on June 5, 2006. These changes are noted below in red type.
On March 9, 2006, President Bush signed into law the USA Patriot Act, Title VII of which is the Combat Methamphetamine Epidemic Act of 2005. The following is a summary of the key Title VII requirements governing the retail sale of all cough and cold products that contain the methamphetamine precursor pseudoephedrine (PSE) or products containing PSE products, for simplicity. Ohio retailers please note. There are three dates of 2006 compliance: April 8,May 17, andSeptember 30.OPA has compiled the following information and we have done our best to provide this information in as easy-to-follow format as possible. As changes occur, we will be sure to keep you updated in the journal, on the OPA website, and through Member E-Bulletins.
Requirements Effective April 8, 2006
1. Daily Sales Limit on Retailer. Retail sales may not exceed 3.6 grams PSE per day per purchaser, regardless of the number of transactions. This affects single- and multi-ingredient sales.
2. 30-Day Purchase Limit on Consumers. Individuals are prohibited from purchasing more than 9 grams PSE per 30-day period on both single- and multi-ingredient products.
3. Non-Liquid Forms / Blister Packs. As of April 8, 2006, retailers may not sell non-liquid form (including gel caps) products, unless the product is packaged in blister packs. No more than two (2) doses may be included in each individual blister. If there are products for which the use of blister packs is technically impossible, then the product may be packaged in unit dose packets.
4. Mail Order Limits. Mail order companies may not sell more than 7.5 grams PSE to a customer within a 30-day period.
Requirements Effective May 17, 2006
for Ohio Retailers Only
Provisions of the Patriot Act will supersede the less restrictive requirements of Ohio's law that goes into effect May 17, 2006.
May 17 State Methamphetamine Law Compliance Date Requirements
May 17, 2006, was the first compliance deadline for the new state methamphetamine law. Previous requirements enacted on April 8, 2006 put pharmacists in compliance with the federal Combat Meth Act of 2005. Both laws place additional requirements on the sale of pseudoephedrine, while the federal law also addresses products containing ephedrine and phenylpropanolamine. A few years ago, the FDA asked manufacturers to voluntarily withdraw phenylpropanolamine products from the market. Since there are currently no phenylpropanolamine-containing OTC products available, the new federal law does not impose any additional requirements that pharmacists in Ohio need to follow at this time. In Ohio, most ephedrine-containing products are classified as schedule V controlled substances which require a prescription to be dispensed. However, there are six excepted ephedrine-containing products listed below. The restrictions for pseudoephedrine now apply to these products as well.
Keep in mind that the final phase in of the federal Combat Meth Act will be September 30, 2006. The Ohio Pharmacists Association will continue to keep you updated as these compliance deadlines approach.
As of May 17, 2006 Ohio retailers must:
Please remember that the Federal statute that went into effect April 8 placed certain sales limit restrictions on all products containing PSE. The May 17 compliance deadline requires only single-ingredient PSE products to be put behind a counter and recorded in a log book.
Requirements Effective September 30, 2006
1. Behind-the-Counter Placement. All products containing PSE must be placed behind a counter (any counter) that is not accessible to purchasing consumers, or in a locked display case that is located on the selling floor. Retailers must give the product directly to the purchaser.
2. Log Book. Retailers must maintain a log book of information on transactions involving products containing PSE. The log book may be maintained in either written or electronic form. (See Log Book Requirements below.)
3. Photo ID. In conjunction with the log book requirement, retailers will be required to ask for photo identification, issued by either a State or the Federal Government or other appropriate identification.
4. Training & Certification. Retailers must train applicable sales personnel to ensure that they understand the requirements of PSE product sales and submit self-certifications to the U.S. Attorney General in this regard. (See Retail Training and Certification below.)
Explanation of Requirements
Products Covered. All products containing PSE, including liquids, gel caps and pediatric formulations, are subject to the provisions of the law. The U.S. Attorney General may grant an exemption for a product if the Attorney General determines that the product cannot be used in the illicit manufacture of methamphetamine.
Log Book Requirements
1. Information Required. Log books must capture the following information for all PSE products:
a. purchaser's signature;
b. purchaser's name and address;
c. date and time of sale;
d. name of product sold; and
e. quantity sold.
2. False Statements Notice. Retailer must provide notice to purchasers that entering false statements or misrepresentations in the logbook may subject purchasers to criminal penalties under Ohio law.
3. Purchasers' Obligations.
a. Sign the log book; and
b. enter name, address, and date/time of sale.
4. Retailers' Obligations.
a. Check information entered by purchaser against photo ID.
b. Verify purchaser is at least 18 years of age.
c. Enter name of product sold and quantity.
5. Exemption. Log book requirements do not apply to purchases of single-sale packages that contain no more than 60 mg of pseudoephedrine.
6. Format. Written or electronic
7. Two-Year Retention Period. Each entry must be maintained for two (2) years following the date of entry.
a. DEA will issue regulations governing the release of log book information. The regulations must provide for the following.
i. Information may be disclosed to federal, state and local law enforcement agencies for law enforcement purposes.
b. Immunity. A retailer who releases log book information in good faith to federal, state or local law enforcement authorities is immune from civil liability.
Retailer Training and Certification
a. Retailers must train all individuals who are involved in the sale of products containing PSE to ensure that these persons understand the requirements that apply.
b. The U.S. Attorney General will issue regulations on the training criteria.
2. Training Certification
a. Retailers must certify that all retail store employees who conduct PSE sales transactions have been trained.
b. Retailers must maintain certifications and records to confirm employee training.
c. Certifications must state that the retailer understands the legal requirements and agrees to comply with them.
d. Separate certifications are required for each place of business.
e. The U.S. Attorney General will establish an effective training date, as well as self-certification criteria through the regulatory process.
f. State and local officials will have access to certifications.
Retailers will be able to submit self-certifications over an Internet website to be established by DEA, and receive an acknowledgement of that submission
The U.S. Attorney General may prohibit persons who sell products in violation of the sales restrictions or the log book, training, and certification requirements from selling any products containing pseudoephedrine.
As of April 8, 2006, mail order sales of products containing PSE will be limited to 7.5 grams PSE per customer during a 30-day period. Prior to shipping, the seller must verify the identity of the purchaser in accordance with regulations to be issued by the U.S. Department of Justice. Mail orders that must be reported to the Attorney General are not subject to the log book, training or certification requirements. Retail distributors who are otherwise exempt from the current AG reporting requirement must, however, report transactions related to products containing PSE.
Title VII. The Combat Methamphetamine Epidemic Act of 2005 does not provide for federal pre-emption. Therefore, more restrictive state laws, remain in effect, as do more restrictive county and local ordinances.
PSE Log Book Language for Ohio Retailers
Include in the log book (or, in the alternative, post in a conspicuous location) the following statement:
"Ohio law prohibits the over-the-counter purchase within any period of thirty consecutive days of more than nine grams of any consumer product in which pseudoephedrine is the only active ingredient. If you purchase a consumer product in which pseudoephedrine is the only active ingredient, you are required to sign a log book that may be accessible to law enforcement officers and to provide a government-issued identification card to verify your identity. Except in limited circumstances, the purchase within any period of thirty consecutive days of more than nine grams of any consumer product in which pseudoephedrine is the only active ingredient, and the purchase by any individual under eighteen years of age of any consumer product in which pseudoephedrine is the only active ingredient, are subject to criminal prosecution or delinquency proceedings in accordance with Ohio law. Also, the provision of false information concerning an individual's name, age, or other identification for the purpose of acquiring any consumer product in which pseudoephedrine is the only active ingredient is subject to criminal prosecution or delinquency proceedings in accordance with Ohio law."
A note to OPA members: This mandated language will soon be changing. When the Federal PSE law passed, it made the language set in Ohio Statute null and void. OPA would advise against expensive signage or placing this on every page of your log book. One copy placed next to the sales counter where it can be viewed by patients is sufficient. We are working with the legislature now to fix this problem.
If the log book is maintained in a tangible format, the statement shall be set forth on the cover of the log book and on each page of the log book. If the log book is maintained in an electronic format, the statement shall be set forth in such a manner that it is presented on the viewing screen to each purchaser who is signing an entry in the log book before the purchaser may sign the entry.