Pharmaceutical and Medical Packaging News Magazine
PMPN Article Index

Originally Published January 1998

SPOTLIGHT

OTC Labeling Reform: What's on the Horizon

by Karen G. Beagley, Midwest Editor

After years of research, comment periods, and meetings between FDA and industry, revised regulations for cut labels and labeling standardization are anticipated to be finalized this coming June and July, respectively. While a transition period will allow industry time to move toward compliance, it's not too soon to start thinking about the changes now.

CUT LABELING

FDA's rules for cut labeling have a somewhat long history, when compared to those for roll labeling, which have been in effect since August 1994. When the proposed rule for the good manufacturing practices (GMPs) was released in 1989, it included the following controversial labeling provision in section 211.122(g): "If cut labeling is used, packaging and labeling operations shall include one of the following special control procedures...."

Optically clear polyester label stock is suitable for clear vials and syringes. Photo courtesy of MACtac

The clause in this section raised two concerns with industry: the special controls would be unnecessarily burdensome to manufacturers, and the provision applied to all labels, even those that consumers would never see. In response to concerns expressed by industry, FDA came out with a revision in 1993 that has been stayed several times since then.

Special controls. The cut labeling provision, as initially proposed, required manufacturers to apply one of the following control procedures:

1. Dedication of labeling and packaging lines to each different strength and each different drug product.

2. Use of appropriate electronic or electromechanical equipment to conduct a 100% examination for correct labeling during or after completion of finishing operations.

3. Use of visual inspection, performed by one person and independently verified by another, to conduct a 100% examination for correct labeling during or after completion of finishing operations for hand-applied labeling.

Industry expressed concern that these procedures would require many companies to acquire expensive equipment and dramatically change labeling procedures, adding significant cost. "It is expensive to ensure 100% electronic inspection but that is what we are doing," says Laurel Benyo, labeling specialist, Ben Venue Laboratories, Inc. (Bedford, OH). "We are adding bar codes to our product labeling, which is a big expense. We also are working on getting bar code readers and scanners on our packaging lines to ensure 100% electronic inspection."

In July 1997, FDA proposed to limit the application of the special control procedures for the use of cut labels in section 211.122(g) to immediate carton labels, individual unit cartons, and multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA also proposed to permit the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed when cut labeling is used.

At the same time, FDA further stayed the date for compliance with section 211.122(g), as it applies to labeling other than immediate container labels, until the effective date of the regulation finalizing its July 1997 proposal. The date for compliance with all other provisions of section 211.122(g) remains August 3, 1994.

The revised provision gives manufacturers another control measure option. "When the FDA put together the original rule, it did not intend for it to apply to everything," says William Bradley, director of technical affairs of the Nonprescription Drug Manufacturers Association (NDMA) based in Washington, DC. "The original rule said if you used cut labels you had to have 100% on-line automatic inspection."

Limiting the scope. As the provisions of section 211.122(g) were initially worded, they placed an unnecessary burden on manufacturers by requiring them to apply the ruling to labels—such as shipping cartons—that were unlikely to reach consumers. FDA's 1997 proposal would limit the scope of section 211.122(g) to immediate container labels, individual unit cartons, and multiunit cartons containing immediate containers that are not packaged in individual unit cartons.

Extended labels allow more information to be included with a package. Photo courtesy of CCL Label, Inc.

The cut labeling provision is a minuscule component of the overall GMP regulation. "Everyone needs to keep in mind that we are dealing with a relatively small portion of the rule," says Don Cadge, chair of the working committee of NDMA's Manufacturing Controls Committee. "Ninety-five percent of the original rule went into effect."

For the proposed ruling, FDA ended the open comments period this past October, and the projected final action is expected to occur in June 1998. "All in all, the proposal is a good thing," Benyo says. "Several years ago there were a large number of recalls due to labeling mishaps in this industry. Anything that prevents labeling mishaps from happening also saves money, because there is such a huge expense involved in a recall."

LABELING STANDARDIZATION

The other FDA proposed rule affecting the labeling industry is the Over the Counter Human Drugs; Proposed Labeling Requirements, referred to as the "label simplification proposal." FDA closed the final comment period October 6, 1997, and the provision has a projected final rule publication date of July 1998.

The proposed regulation calls for standardizing the placement of directions, warnings, and uses on labels. The provisions were developed in part through a focus group research study that found that consumers wanted OTC medication labels to present information "in plain English" and in larger type and also to emphasize side effects and warnings in boldface type. "There is a big push to standardize the content and form of labels," says Emily Moore, marketing communications supervisor, Sonoco Engraph Label (Atlanta). "We are very involved with our customers, watching what happens so everyone can be in compliance."

"The industry had done all it could to improve readability," says NDMA's Bradley. "Standardization was the next step. The FDA action calls for a standard order of information, bulleted format, interchangeable terms, and standard headings and subheadings."

With a MACtac label, pharmacists can remove instruction stickers off the prime label and affix them directly to individual dispensing containers. Photo courtesy of MACtac

Order of information. The basic elements of the proposal list the standard order of information as: active ingredients and purposes, uses (formerly indications), warnings, directions, inactive ingredients, and other information. "We do believe there is a benefit to standardization, but we did submit some comments," says Bradley. "We feel there are some troublesome details in the proposal." Specifically, Bradley has stated that the requirements of a minimum 1-point leading between lines and 2-em spacing before bullets when on the same line are arbitrary, increase space needs, and are not necessary for readability.

Recommendations. NDMA drafted the following recommendations for labeling standardization:

• Wrap bullets within subheadings, but maintain adequate space.

• Use condensed typeface if needed.

• Use more than one panel and maintain the flow of information.

• Reduce leading, but don't let the letters touch.

• Decrease type size as a final resort.

NDMA is also advocating a three-year implementation instead of FDA's proposed two-year period. Some pharmaceutical companies have expressed concern that they will not be able to exhaust existing label inventories within two years, and that a three-year extension would lessen the burden on suppliers. "The FDA ruling will require changes across the board," says Ralph Palatucci, director of healthcare systems, Sonoco Engraph (Delran, NJ). "Everyone is going to have to make sure they don't have too much inventory before the regulation goes into effect."

Label language. Another issue is the wording proposed by FDA. "The FDA received a little over 1800 comments," says Chris Moorman, manager, regulatory affairs, Healthcare Division, Procter & Gamble Co. (Cincinnati), and a participant on the NDMA task force. "Ninety-one percent of the draft dealt with whether the phrase 'or pharmacist' should be included on the label. NDMA is recommending the phrase 'health professional' to encompass it all. We don't know where FDA will go with this."

NDMA has asked FDA for a working meeting to hash out many of these issues. "We would like to make the bulk of the ruling hit 80% of the products out there," says Moorman. "We also feel strongly that we need three years to implement [the rule] based on our economic forecasts. FDA is working hard to ensure that this proposed ruling meets the target date. We've given them our comments, and now we would like to work with them. We need flexibility to make this all work."

Extended labels. One solution manufacturers are embracing is extended labels, which are increasing in popularity. Extended booklet labels allow for more information and even possibly larger type to be given to the consumer. "The labeling industry has experienced over 30% growth," says Silvano Ferrazzo, marketing manager film and pharmaceutical products, MACtac, a Bemis Co. (Stow, OH). "We've seen large growth in extended booklets. Booklets allow for more information to be given to the consumer at the point of purchase." Des Laffan, general manager, PharmaLabel (Greensboro, NC), adds, "Extended text labels do allow for more information to stay with the package."

Label companies are developing innovative ways to help pharmaceutical manufacturers standardize information on a variety of products. "To address the content standardization issue, we've combined our IV hanging label with an expanded content label," says Randy Cowan, senior product manager for expanded content labeling, CCL Label (Sioux Falls, SD). "Our customers want all the information to stay with the IV bag while giving them the room they need for all the necessary copy. We needed the IV hanging feature with the ability to attach the label and keep the information handy."

THE FUTURE

When the proposed FDA regulations go into effect, the labeling industry will be forced to move quickly to implement the required changes. "As a supplier we are being asked to assume a greater role in compliance issues," says Greg Tschida, president, Accraply, Inc. (Plymouth, MN). "In the past we would be given a specification package. Now we are getting general specifications and we work with the customer to find the information that is pertinent to us. Instead of being told the procedures, we, in many cases, tell them. It leads to more of a working relationship."

Manufacturers will also have higher expectations for their suppliers. "Pharmaceutical companies are expecting their printers to be in compliance with and accountable to FDA regulations," says Jim Stead, quality assurance manager, CCL Label (Monrovia, CA). "They are more cognizant of where labeling mishaps can happen and look at the whole production process from printer to the end of their production lines. The pharmaceutical companies want to deal with printers that resolve the stringent GMP compliance issues. As a printer, you have to demonstrate your ability to comply."

However, compliance with the new regulations is just one aspect of labeling. "Customers are dealing with the compliance issues," says Tom Flottman, president, The Flottman Co. (Crestview Hills, KY). "But they still want what they have always wanted: quicker turnaround, improvement in process control, and on-line vision systems." Some things never change.