Certification

The Healthcare Compliance
Packaging Council
...improving patient outcomes with unit dose packaging

Thank you for your interest in the Healthcare Compliance Packaging Council's Seal of Certified Compliance Packaging. The Certified Compliance Packaging Seal defines and distinguishes pharmaceutical packaging formats that improve adherence to medication regimens.

Based on independently-developed criteria, in fact, the Certified Compliance Packaging Seal offers benefits including:

	An eye catching icon that instantly identifies Certified Compliance Packaging.
	Approved by the U.S. Food and Drug Administration for specific pharmaceutical labeling applications.
	Easily and effectively communicates the commitment of a pharmaceutical manufacturer to improve pharmaceutical compliance through superior packaging.
	Addresses preferences of physicians, pharmacists, and patients that pharmaceuticals be packaged in formats that improve adherence to drug regimens.
	The licensing of each HCPC Certified Compliance Packaging Seal is announced in a direct mailing to formulary directors nationwide.
	Additional exposure through the HCPC for packages that carry the Certified Compliance Packaging Seal.
	The HCPC Certified Compliance Packaging Seal can be used with promotional materials, advertisements, and on the packaging itself, all at the licensee's discretion.

All things considered, the HCPC Certified Compliance Packaging Seal provides tremendous added value for those packaging formats which meet our criteria of use. To view the HCPC's compliance packaging promotional materials, follow this link.

Certified Compliance Packaging
Evaluation Procedures

Packages eligible to use the Certified Compliance Packaging Seal must have each of the attributes identified on behalf of the HCPC by Dr. Ralph Small of the Medical College of Virginia's School of Pharmacy Sciences.

If you believe that your package meets our criteria (please see below), and would like to have your package considered as a candidate for the HCPC Certified Compliance Packaging Seal, this is the process to be followed:

Step 1: Identify an independent testing laboratory to perform the evaluation

The HCPC will not review, evaluate, or even accept packages that are candidates for the Certified Compliance Packaging Seal. Manufacturers must identify an independent testing laboratory to which their package will be sent for evaluation. Testing labs which have been pre-approved by the HCPC Board of Directors include:

Perritt Laboratories
145 South Main Street
P.O. Box 147
Hightstown, NJ 08520
(609) 443-4848

Child Related Research
4141 Highland Drive 1133
Suite 308
Salt Lake City, UT 84124
(801) 467-9440

Great Lakes Marketing, Inc.
3103 Executive Parkway
Toledo, OH 43606
(419) 534-4700

If you prefer to use a different testing lab to evaluate your package, you must get advance approval from the HCPC Board of Directors. Evaluation fees are to be negotiated between the testing lab and the package manufacturer, without the involvement of the HCPC.

Step 2: Inform the HCPC of the testing laboratory that has been selected

Once a testing lab has been selected, contact the HCPC and give us the name of the lab that will evaluate your package, and a contact person at the lab. The HCPC will forward an evaluation form and certification statement for use by the lab. You will be responsible for forwarding the candidate package, its corresponding patient package insert, and any other materials that the lab will need to review your package, directly to the test lab. Do not send packages to the HCPC.

Step 3: Package Evaluation

The evaluation is to be conducted by the independent testing laboratory based on their expertise. Laboratory personnel will determine whether the candidate package has each of the attributes needed to utilize the HCPC Certified Compliance Packaging Seal.

Step 4: Seal Awards/Conditions of Use

If the independent lab certifies that the candidate package has each of the attributes required for the Certified Compliance Packaging Seal, the packaging manufacturer will be eligible to license the use of the Seal on an annual basis. Terms of use will be spelled out in a contractual agreement between the HCPC and the packaging manufacturer. The annual licensing fee is $24,000.

Certified Compliance Packaging Criteria

Following is evaluation criteria for use of the HCPC Certified Compliance Packaging Seal:

1. Does the package have a feature that relates dosage units to different times and/or different days?
Yes No

2. Is the package portable (i.e., can the package be carried in a patient's pocket or purse, or is the package designed so that each day's recommended dose can be separated so that it continues to be contained in the manufacturer's original packaging, and is suitable for carrying in a patient's pocket or purse)?
Yes No

3. Does the package provide a value-added service for the patient (i.e., does it organize the medications, enhance product stability, enhance compliance, etc.)?
Yes No

4. Is the package designed to show evidence that each dosage unit has been removed?
Yes No

5. Does the package have a mnemonic feature incorporated into its design?
Yes No

6. Is there an instructional sheet (patient package insert) that accompanies the package and has the following elements:

	Contains information about the medication condition
	Contains information about the medication, including: 1) Proper use of medication; 2) Potential side-effects; 3) Potential drug interactions; 4) Encourages compliance; 5) Is written at the ninth-grade level or lower (as measured by the Flesch Grade Level or Flesch Kincaid where essential technical terms, such as product nomenclature, are excluded from the measurement)

Yes No

7. A contrasting print design (either dark print on light background or light print on a dark background)
Yes No

8. A print font that is 6 point or greater
Yes No

If you have any questions regarding this program, or need additional information please feel free to call Peter Mayberry, HCPC Executive Director, at 703/538-4030 or click here to send us an e-mail.