DXM Sales Age Restriction Reaches Florida; CHPA Navigates PSE Road

Florida is the first of several states CHPA expects in 2016 will pass legislation banning sales of DXM-containing OTCs to minors. CHPA looks this year to support similar bills in Arkansas, Pennsylvania and Ohio while keeping an eye toward state activity on sales of PSE-containing OTCs.

Florida becomes the 10th state to prohibit sales of dextromethorphan-containing OTC cough products to minors, the first of several states the Consumer Healthcare Products Association expects to pass DXM bills in 2016.

“Getting Florida was key,” said Carlos Gutierrez, a senior director and head of state government affairs at CHPA. “Given the number of people in the state, and getting California, New York and the next largest state we hope to do something in would be Texas, and that would be [affecting] a significant portion of the population of the US.”

In Alaska, House members passed DXM legislation that is before a Senate committee and CHPA is supporting bills setting an age restriction in Arkansas, Pennsylvania and Ohio.

“We expect legislation to be filed in [Delaware] in the next two weeks as well,” Gutierrez said in an interview.

“Following Florida's lead, we are working with lawmakers to help them understand the importance of limiting access to DXM to the teen population, while ensuring continued unfettered access to these important medications by adults who need them,” he said.

DXM legislation in Texas would not come until 2017 when state legislators are back in session, noted Gutierrez. “We will be visiting with lawmakers and stakeholders this summer to gauge interest in pursuing legislation next year,” he said.

The Texas legislature does not meet in even-numbered years. Bills introduced in the state House and Senate during the 2015 session did not reach the floor for a vote.

Sales of DXM-containing OTCs to consumers under 18 most recently were banned in New Jersey and also have been prohibited in Arizona, California, Kentucky, Louisiana, New York, Tennessee, Virginia and Washington (Also see "Industry Roundup: NJ Limits DXM Sales, RB Out-Licenses K-Y In UK" - Pink Sheet, 15 Oct, 2015.).

Florida Levies $100 Fines

CHPA President and CEO Scott Melville said Florida joins other states "that have acknowledged that limiting teen access to DXM is an effective way to prevent abuse." Florida's and other states' DXM laws help parents to prevent abuse by their children but maintain consumers' OTC access to DXM products to treat common cough symptoms.

The Florida legislation, which passed the Senate in a 39-1 vote and the House 115-2, was signed by Gov. Rick Scott (R) on April 1 and takes effect in January 2017. It prohibits manufacturers, distributors and retailers "from knowingly or willfully selling a finished drug product that contains DXM to an individual under the age of 18 without a valid prescription,” according to a bill summary.

The legislation requires retailers to ask for proof of age from consumers who appear younger than 25 prior to selling an OTC that contains DXM. It establishes enforcement procedures and imposes civil citations and fines on retailers and their employees who violate the legislation. Each violation is subject to a fine of up to $100.

Gutierrez said CHPA will continue education efforts through StopMedicineAbuse.org, an initiative it sponsors to educate parents, teens and others about DXM abuse. One in 30 teens has reported taking excessive doses of the ingredient to get high, CHPA says.

DXM age-restriction bills that members of Congress have introduced over the past decade have not gained support. Most recently, the DXM Prevention Act of 2015, H.R. 3250, was introduced by Reps. Bill Johnson, R-Ohio and Doris Matsui, D-Calif., and has not moved out of committee (Also see "DXM Age-Restriction Legislation Returns With Industry Backing, Slim Chance" - Pink Sheet, 3 Aug, 2015.).

PSE Action In States

CHPA also is tracking states' legislative activity on pseudoephedrine-containing OTCs.

Gutierrez noted the most recent activity came in Indiana with a law, which Gov. Mike Pence (R) signed on March 21 and which takes effect in July, banning OTC sales of PSE to known drug felons and allowing tracking of any PSE prescription by the state’s prescription drug monitoring program.

The law also gives pharmacists a gatekeeper role in determining whether consumers purchase any PSE product without prescriptions. According to a summary on the Indiana legislature website, the law establishes that when a pharmacist determines a consumer "does not have a relationship on record with the pharmacy, the pharmacist shall make a professional determination as to whether there is a legitimate medical or pharmaceutical need for ephedrine or pseudoephedrine before selling ephedrine or pseudoephedrine" to the person without a prescription.

"We are working with lawmakers to help them understand the importance of limiting access to DXM to the teen population, while ensuring continued unfettered access to these important medications by adults who need them.” – Carlo Gutierrez, a CHPA senior director and head of state government affairs

The bill also provides civil protections. “A pharmacist who in good faith does not sell ephedrine or pseudoephedrine to an individual under this subdivision is immune from civil liability unless the refusal to sell constitutes gross negligence or intentional, wanton, or willful misconduct,” it states.

Gutierrez says while the Indiana requirement limits access for some consumers, it is better than requiring all consumers to present a prescription for the products, as lawmakers in the state proposed in 2014.

“They came up with a resolution at the end of the day that we didn't fully support, but I do think it is a much better step in the right direction,” he said.

In addition to Indiana, New York, South Carolina and West Virginia in 2014 introduced bills requiring prescriptions for PSE-containing OTCs, but none moved out of committee.

Sen. Joe Manchin, D-WV, is a staunch advocate for requiring prescriptions for all PSE products and in 2015 contacted the state’s lawmakers to support Rx-only legislation. Some drug store chains in West Virginia since 2014 have been offering only tamper-resistant single-ingredient PSE OTC products, formulated to resist extraction of the ingredient; the chains also stock only those products in stores in other states near the West Virginia border (Also see "To Curb PSE Diversion, Retailers Lead By Example With Emphasis On Tamper-Resistant Products" - Pink Sheet, 19 Sep, 2014.).

However, the Asthma and Allergy Foundation of America is concerned West Virginia retailers’ practice could spread to other states and limit more consumers’ access to PSE products. AAFA in July published results of a survey it commissioned showing that most consumers in Illinois, Indiana, Oklahoma, Tennessee and Missouri oppose not having a choice of single-ingredient OTC PSE products at their local grocery or drug stores (Also see "Allergy Group Advocates To Maintain Pseudoephedrine Product Choices" - Pink Sheet, 20 Jul, 2015.).

Arkansas in 2011 passed legislation similar to the Indiana bill that also requires consumers, other than active-duty military members, to have an in-state driver's license or other official identification to buy any PSE products with a prescription.

Rx-only PSE laws are limited to Mississippi and Oregon, but several states and local governments limit the daily and monthly product purchases lower than the level allowed in the Combat Methamphetamine Epidemic Act Congress passed in 2006 to require behind-the-counter sales for nonprescription PSE products.

CHPA supports state laws that ban nonprescription sales of PSE-containing products to people with meth-related convictions but opposes any that single out certain types of the products (Also see "All PSE Formulations Deserve Equal Marketplace Billing – CHPA" - Pink Sheet, 22 Jun, 2015.).