# June 11, 2003

Food and Drug Administration

5630 Fishers Lane, Room 1061

Department of Health and Human Services

Rockville, MD 20852.

Re: Docket No. 02N-0204 RIN 0910-AC26

Comment on Bar Code Label Requirement for Human Drug Products

Dear Sir or Madam:

The Interagency Regulatory Analysis Committee (IRAC)[^1] Pharmaceutical
Workgroup[^2] offers this letter to comment on FDA's Bar Code Label
Requirement for Human Drug Products. **We believe, in order to assure
that any waste drugs are disposed in the right manner, the FDA should
also require that the label include the waste disposal status of the
pharmaceutical under EPA's Resource Conservation and Recovery Act
(RCRA).** Improperly disposed waste pharmaceuticals contribute to poor
water quality through the inadvertent introduction of potentially
harmful man-made chemicals including endocrine disrupters, persistent
bioaccumulative toxins, and other organic wastewater contaminants.

### **Pharmaceutical Waste as RCRA Waste**

Pharmaceuticals regulated under RCRA must be disposed of at a permitted
hazardous waste facility. RCRA regulates hazardous wastes that are
ignitable, reactive, toxic or corrosive. Wastes containing hazardous
levels of certain toxic chemicals and heavy metals (e.g., barium,
mercury, silver and cresol) are also regulated by RCRA. Some drugs
contain active ingredients listed as hazardous discarded chemical
products on the RCRA U and P lists. The State of Florida has compiled a
fact sheet on regulation of pharmaceuticals that provides a partial list
of federally regulated pharmaceutical wastes. *A Guide on Hazardous
Waste Management for Florida's Pharmacies* is located at
<http://www.floridacenter.org/brochures_bulletins/rcra_pharmacies.pdf>.

Many pharmaceuticals that are not useable and become waste designate as
a hazardous waste under RCRA. A survey conducted in King County,
Washington[^3] revealed that, with few exceptions (mostly large
hospitals, pharmacies and those using chemotherapy drugs), the health
care industry has been unaware of its responsibility to meet federal
hazardous waste regulations. The larger hospitals and pharmacies use
reverse distributors[^4] to manage much of their pharmaceutical
discards. However, on the hospital floor and in smaller medical
facilities and doctors' offices, the staff is not in compliance with
RCRA regulations-- not because they don't want to be but because they
are overworked and stressed. For example, a nurse caring for six
patients on a night shift may, within the course of an hour, generate a
half-full IV bag of antibiotic medication, spilled pills, and an unused
dose of injectable pharmaceutical. Imagine a nurse in a clinic trying to
figure out whether the leftover drug in a vial designates as RCRA waste.
Does it contain mercury as a preservative? Does the drug contain any U
or P list chemicals? This information is not readily accessible --
pharmaceuticals do not come with Materials Safety Data Sheets and their
labels do not contain a list of hazardous ingredients. Medical personnel
find it almost impossible to determine how a drug should be disposed
when no longer needed, in part because there are an estimated 40,000
pharmaceutical formulations currently on the market. Because of this,
many RCRA drugs are improperly disposed to the sanitary sewer, on-site
(septic tank), solid waste and/or biohazard disposal systems. For the
complete survey report see
[http://www.metrokc.gov/hazwaste/pubs/studies.html#pharmwastesurvey.](http://www.metrokc.gov/hazwaste/pubs/studies.html#pharmwastesurvey)

Discussions with other health care professionals, regulators and
concerned citizens across the country indicate that improper disposal of
pharmaceutical RCRA waste is the norm rather than the exception.[^5]
Extrapolating from the King County survey, we estimate the national
volume of pharmaceutical waste to be nearly 80 million pounds annually
(including IV fluids). [^6] According to conversations with current and
former reverse distributors[^7], approximately five percent of hospital
waste is RCRA regulated. Therefore, **the approximate annual total of
RCRA pharmaceutical waste is four million pounds. Much of this is
improperly disposed**. Providing RCRA disposal information on the bar
code label would greatly reduce this barrier to compliance and decrease
negative impacts on the environment and ultimately human health.

### **Pharmaceuticals in the Environment**

Recent research has revealed that drugs exist in our environment both as
a result of improper disposal of RCRA-regulated drugs and the discharge
of unmetabolized and metabolized pharmaceuticals from patient excreta
into the sanitary sewer. In a study conducted in 1999 by United States
Geologic Service (USGS)[^8], 139 streams in 30 states were analyzed for
95 different organic wastewater contaminants, including pharmaceuticals.
Samples were taken downstream from outfalls of densely populated urban
centers. Eighty-two of the 95 organic wastewater contaminants were
detected in at least one sample. One or more of the organic wastewater
contaminants were found in 80 percent of the streams. Thirteen percent
of the sites had more than twenty organic wastewater contaminants. For
the complete study view the link at
<http://toxics.usgs.gov/pubs/FS-027-02/> The USGS conducted two related
studies, one on pharmaceuticals, hormones and other organic wastewater
contaminants in wells (2000) and in sources of drinking water (2001).
Data from these studies is currently being analyzed.

Mercury is commonly used in pharmaceuticals as a preservative, and all
pharmaceuticals containing mercury designate as RCRA waste. Premier
Safety Institute, a leading buying group for hospitals, published a list
of 674 mercury-containing pharmaceuticals. Drugs with mercury include
sulfacetamide sodium (an eye solution), tetanus shots, contact lens
cleaners, preparation H, mumps skin tests, nasal sprays (Neo-synephrine,
Dristan) and ophthalmic drops. The list is located on at
<http://www.premierinc.com/all/safety/publications/10-02_downloads/02_HG_drug_list_08-22-02_public.xls>.
Because they are not labeled as such, most mercury-containing
pharmaceutical wastes are improperly disposed in biohazard containers,
trash and sanitary sewer.

### **Manufacturer Liability**

New laboratory methods allow scientists to identify more compounds than
ever before in our streams. This has increased public awareness of the
damaging impact of pharmaceutical wastes in the environment and its
direct link to public health. As this continues to escalate, the
liability will most likely point to the drug manufacturer. The
Comprehensive Environmental Response, Compensation and Liability Act
(CERCLA), and its amendments known as Superfund,[^9] clearly establish
the liabilities to the responsible parties contributing to a release of
hazardous substances to the environment. If manufacturers have not
provided pharmacists, medical personnel and other handlers of
pharmaceutical wastes with the adequate disposal information, their
liability could increase under CERCLA.

Without proper disposal labeling, manufacturers open themselves to
liability risks from the public health perspective as well. As consumers
realize the negative health impact caused by improperly disposed
pharmaceutical wastes, citizens could file class action suits against
the industry. This has happened in both the tobacco and asbestos
industries, forcing them to pay millions of dollars to those harmed.
Pharmaceutical manufacturers can mitigate this liability by identifying
RCRA pharmaceuticals in the bar code and thereby showing they are making
every effort to provide the necessary information to the health care
industry. This information, while hidden to the typical consumer, could
then be used by health care professionals to make proper waste-handling
decisions.

### **Conclusion**

Due to significant challenges regarding waste pharmaceutical disposal
and its negative impact on the environment and ultimately human health,
we believe the FDA should require that the bar code label include the
waste disposal status of the pharmaceuticals under RCRA regulations.
This would eliminate a huge barrier to compliance that now exists in the
health care industry. Using the bar code to label the RCRA status would
be discrete and not unduly alarm patients taking the drugs.

It is the opinion of this workgroup that a voluntary approach to
labeling pharmaceuticals as RCRA waste would not work. The FDA worked
for years to encourage the pharmaceutical manufacturers to voluntarily
label their drugs with the National Drug Code. Because the voluntary
approach failed, the FDA is now proposing this rule.

Sincerely,

Dave Galvin

Manager, Local Hazardous Waste Management Program in King County for

The Interagency Regulatory Analysis Committee, Pharmaceutical Workgroup

Contact: Cheri Grasso, 206-263-3089, <Cheri.Grasso@metrokc.gov>

See next page for list of signees

+-----------------------------------+-----------------------------------+
| > IRAC PHARMACEUTICAL WORKGROUP   |                                   |
| > MEMBERS                         |                                   |
+-----------------------------------+-----------------------------------+
| > Alice Chapman                   | > Doug Gallucci                   |
| >                                 | >                                 |
| > Environmental Engineer          | > University of Washington        |
| >                                 | >                                 |
| > King County Hazardous Waste     | > Environmental Health & Safety   |
| > Management                      | >                                 |
| >                                 | > PO Box 354400                   |
| > 130 Nickerson St., #100         | >                                 |
| >                                 | > Seattle, WA 98195               |
| > Seattle, WA 98109-1658          |                                   |
+-----------------------------------+-----------------------------------+
| > Cheri Grasso                    | > Margarita B. Devera             |
| >                                 | >                                 |
| > Hazardous Waste Investigator    | > WA State Department of Labor &  |
| >                                 | > Industries                      |
| > King County Hazardous Waste     | >                                 |
| > Management                      | > 616 120^th^ Ave. N.E. #C201     |
| >                                 | >                                 |
| > 130 Nickerson St., #100         | > Bellevue, WA 98005-3037         |
| >                                 |                                   |
| > Seattle, WA 98109-1658          |                                   |
+-----------------------------------+-----------------------------------+
| > Elsie Hulsizer                  | > Alan B. Jones                   |
| >                                 | >                                 |
| > Manager, King County Industrial | > Alan B. Jones, Ph.D.            |
| > Waste                           | >                                 |
| >                                 | > 17629 NE 138th St.              |
| > 130 Nickerson Street, Suite 200 | >                                 |
| >                                 | > Redmond, WA 98052-1226          |
| > Seattle, WA 98109               |                                   |
+-----------------------------------+-----------------------------------+
| > Stan Jeppesen                   | > Debra Oliver                    |
| >                                 | >                                 |
| > Pharmacist Investigator         | > Hazardous Waste Investigator    |
| >                                 | >                                 |
| > Washington State Board Of       | > King County Hazardous Waste     |
| > Pharmacy                        | > Management                      |
| >                                 | >                                 |
| > P.O. Box 47863                  | > 130 Nickerson St., #100         |
| >                                 | >                                 |
| > Olympia, WA 98504-7863          | > Seattle, WA 98109-1652          |
+-----------------------------------+-----------------------------------+
| > Linda Reiter                    | > Steve Burke                     |
| >                                 | >                                 |
| > Source Control Representative   | > Seattle-King County Public      |
| >                                 | > Health                          |
| > Wastewater Management           | >                                 |
| >                                 | > 999 Third Avenue, Suite 700     |
| > City of Tacoma                  | >                                 |
| >                                 | > Seattle, WA 98104-4099          |
| > 2201 Portland Avenue            |                                   |
| >                                 |                                   |
| > Tacoma, WA 98421                |                                   |
+-----------------------------------+-----------------------------------+
| > Peggy Rice                      | Don Williams                      |
| >                                 |                                   |
| > King County Industrial Waste    | > Executive Director              |
| >                                 | >                                 |
| > 130 Nickerson St., #200         | > Washington State Board of       |
| >                                 | > Pharmacy                        |
| > Seattle, WA 98109-1658          | >                                 |
|                                   | > PO Box 47863                    |
|                                   | >                                 |
|                                   | > Olympia, WA 98504               |
+-----------------------------------+-----------------------------------+
| > L.B. Sandy Rock, M.D., MPH      | > Phil Schoeneman                 |
| >                                 | >                                 |
| > President                       | > P.S. Industries, Inc.           |
| >                                 | >                                 |
| > Interpretive Consultations,     | > 1100 Second Ave., #B1           |
| > Inc.                            | >                                 |
| >                                 | > Seattle, WA 98101               |
| > P.O. Box 7235                   |                                   |
| >                                 |                                   |
| > Bellevue, WA 98008-1235         |                                   |
+-----------------------------------+-----------------------------------+
| > Charlotte Smith                 | > Dave Waddell                    |
| >                                 | >                                 |
| > President                       | > King County Hazardous Waste     |
| >                                 | > Management                      |
| > PharmEcology                    | >                                 |
| >                                 | > 130 Nickerson St., #100         |
| > 200 S Executive Dr., #101       | >                                 |
| >                                 | > Seattle, WA 98109-1658          |
| > Brookfield, WI 53005            |                                   |
+-----------------------------------+-----------------------------------+
| > Damon Taam                      |                                   |
| >                                 |                                   |
| > Spokane Regional Solid Waste    |                                   |
| > System                          |                                   |
| >                                 |                                   |
| > 808 W Spokane Falls Blvd, 7th   |                                   |
| > Floor                           |                                   |
| >                                 |                                   |
| > Spokane, WA 99201               |                                   |
+-----------------------------------+-----------------------------------+

[^1]: IRAC is comprised of more than 350 members from 160 regulatory
    agencies in Washington State and is staffed by the Local Hazardous
    Waste Management Program in King County (Seattle, WA). IRAC
    addresses regulatory coordination and interagency cooperation and
    provides a forum for agencies to work together to address regulatory
    issues, conflicts and inconsistencies.

[^2]: Questions relating to the proper disposal and recycling of
    pharmaceutical wastes in Washington were brought to IRAC by the
    Medical Industry Roundtable (MIRT). The IRAC Pharmaceutical
    Workgroup is comprised of representatives from the pharmaceutical
    industry, reverse distribution businesses, non-profit organizations,
    educational institutions and regulators.

[^3]: The survey was developed and conducted in one month to respond to
    a public comment period. Therefore, the survey results should be
    viewed as a snapshot in time of some drug waste generators and their
    practices.

[^4]: The reverse distribution system was set up in 1984 to facilitate
    the return of unused pharmaceuticals to the manufacturers for
    credit. It is used primarily by large hospitals and pharmacies.

[^5]: Conversations between the IRAC Pharmaceutical Workgroup and
    Charlotte Smith, founder of Capital Returns (a reverse distributor)
    and currently president of PharmEcology Associates, LLC. (June 2001
    -- March 2003); conversations with Bill Kappler of the U.S.
    Environmental Protection Agency, RCRA Enforcement and Compliance
    Branch, North Section, Atlanta, GA (March 2002 -- December 2002);
    conversation between Cheri Grasso of IRAC and Catherine Zimmer of
    Minnesota Technical Assistance Program (June 2002); conversation
    between Cheri Grasso of IRAC and Mike Schott of the California
    Department of Health (June 2002).

[^6]: The extrapolation is based on the assumption that similar
    facilities around the country use the same pharmaceuticals at the
    same rate as a facility in King County. This assumption has not been
    tested.

[^7]: Conversation with Art Snarzyk, Compliance Manager of Easy Returns
    estimated between 3% and 8% (April 2003). Conversation with
    Charlotte Smith, founder of Capital Returns, estimated 5.5% and 7.5%
    (April 2003).

[^8]: "Pharmaceuticals, Hormones, and Other Organic Wastewater
    Contaminants in U.S. Streams, 1999-2000: A national reconnaissance,"
    March 15, 2002 Environmental Science & Technology, v. 36, no. 6,
    pages 1202-1211.

[^9]: 42 U.S.C. Chapter 103, The Comprehensive Environmental Response,
    Compensation and Liability Act of 1980, as amended by the Superfund
    Amendments and Reauthorization Act of 1986 (SARA).