Pharm industry responds to proposed FDA standard

Mark A. DeSorbo

ROCKVILLE, MD—Some simply asked for an extension on the comment period, while others expressed just how urgent it is for Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) to forge on in its efforts to establish standards that would keep drugs and medical products free of hospital-borne viruses and bacteria.

“We are reading the comments as they come in and categorizing them,” says Andrea Masciale, regulatory counsel for CDER, which has extended its public com-
ment from mid-August until October 13, “Some just wanted the comment period extended, but a lot of the comments I’ve read are in support of what we are trying to do.”

In an August e-mail to the FDA, Frederick S. Mayer, president of Pharmacist Planning Service Inc., said the non-profit public health, consumer pharmacy education organization supports the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness as a means to establish and regulate pharmacy practices.

“It is urgent that enforceable federal regulations be written to stem the tide of fraud and quackery that is now unchecked in the practice of pharmacy compounding,” Mayer wrote.

The concept paper is largely based on Chapter 1206 of United States Pharmacopoeia, which is also undergoing revision. Chapter 1206 addresses numerous procedures for facilities, personnel and gowning, training, aseptic processing, cleaning and sanitizing.

The paper, docket number 00N-1357, is the center’s first attempt to establish a baseline for drug preparation standards. The effort stems from a statute in the FDA Modernization Act of 1997 that mandates drugs and sterile products may be prepared if they are not identified by the FDA in regulation as a drug product that presents difficulties when compounding, causing adverse affects on safety and effectiveness.

“The potential for contamination is also a factor when considering the handling of bulk material,” wrote Sally Illene Ferbach, operations manager of drug maker Methapharm Inc. (Coral Springs, FL).

Although Methapharm’s inhalant Provocholine is controlled and tested under current good manufacturing practices (cGMP) and FDA regulations, Ferbach explained that impurities cannot exceed 0.1 percent. “The drug product is made with chemicals, sold in bulk for compounding. It is not required to have microbiological tests and may be contaminated,” she wrote. “Lack of consistent testing on the bulk material may result in questionable safety and efficacy issues.”

A July letter from Stephen G. Arter, a pharmacist with Parkview Hospital (Fort Wayne, IN), however, expressed that the pharmacist should be able to compound medicines as needed from the prescription of a physician and the FDA should leave policies to individual states.

“This should remain a state regulated matter. My practice is primarily in the pain and symptom control of terminal patients and preparing extemporaneous prescriptions is imperative to the comfort of these patients,” he wrote.
Once comments and transcripts from a Pharmacy Compounding Advisory Committee meeting on the matter are reviewed, Masciale says either a proposed rule or an advance notice of proposed rule making will be drafted. “A proposed rule is more concrete, while advance notice is more of a developmental stage,” she adds, saying either draft is recorded in the federal register and posted on the web site.

CDER began compiling public comments on the concept paper in August. The pharmaceutical community has until October 13 to comment on the concept, but Masciale says there will be at least one more opportunity for industry professionals to comment.

For more information on the concept paper Drug Products That Present Demonstrable Difficulties for Compounding Because of Reasons of Safety or Effectiveness, contact Andrea Masciale, regulatory counsel for CDER, at (301) 594-2041, or write to Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, and reference Docket Number 00N-1357.


Easily post a comment below using your Linkedin, Twitter, Google or Facebook account. Comments won't automatically be posted to your social media accounts unless you select to share.