FDA identifies ingredients to be considered non-GRASE
ROCKVILLE, Md. The Food and Drug Administration last week identified a host of ingredients and indications that will be considered not generally recognizable as safe and effective as part of a proposed rule.
Industry will have 60 days to comment on the proposed rule. According to the agency, FDA first requested data on these ingredients/indications in December 2003 as part of its ongoing review of OTC drug products.
The following ingredients and indications will be identified as non-GRASE if the rule is ratified:
- Any external analgesic drug products containing aloe vera or urea
- Any topical antimicrobial drug products containing aloe vera
- Any drug products containing urea for any labeled claims
- Ammonia as a reflex stimulant
- All skin protectant blister guard drug products
- Any skin protectant drug products labeled with claims or directions for use as a nipple protectant (previously referred to as breast creams for use when nursing), except lanolin
- Any drug products formulated as a wet dressing other than skin protectant and astringent drug products formulated and labeled in accordance with 21 CFR part 347
- Any drug products labeled with claims or directions for the following uses—bed-wetting deterrent; blemish remedy (other than topical acne drug products); bunion remedy; drawing salve (for drawing or removing splinters, slivers or similar items), except ichthammol; foot balm, bath, or other topical dosage forms for any ‘‘foot’’ claims (including relieving foot muscle strains and soreness from working out), other than topical antifungal drug products; impotency cure; medicated bath preparation; nonantimicrobial skin wound cleanse; topical products for treatment or prevention of male urethral problems; treatment or prevention of prickly heat; urinary acidifier or urinary alkalinizer; weight control drug products with ingredients formulated as an impregnated body wrap; and wound wash saline.
CDER responds to Senator’s inquiry
WAHSINGTON As the Food and Drug Administration prepares its response to the question from Sen. Sherrod Brown, D-Ohio, on how best to hold drugmakers accountable for drug quality, the Center for Drug Evaluation and Research’s Office of Compliance is highlighting the agency’s efforts to examine the drug supply chain, reiterating regulations that the New Drug Application holder is responsible.
“Ultimately the dosage form manufacturer with its name on the label is responsible,” the Office of Compliance said. “Our regulatory structure under the [Food, Drug and Cosmetic] Act, and implementing regulations, provide for the identity, strength, quality and purity of the drug and the prohibited acts provide for civil sanctions and criminal penalties for failure to do so.”
The office commented on the best way to hold firms accountable for drug quality incidents, such as the heparin contamination, in which the manufacturer complies with FDA regulations—passing inspections and conducting U.S. Pharmacopeia tests on incoming products—but unknowingly distributes adulterated drugs anyway.
“In light of the question on how to deal with incidents such as heparin, sourcing ingredients, testing and [control of the] supply stream … are important elements FDA and other regulators are examining and encouraging industry to focus on to prevent such incidents,” the Office of Compliance said.
UMB Healthcare, drugstore.com form partnership
BELLEVUE, Wash. UMB Healthcare Services, a division of UMB Financial Corporation, and drugstore.com on Tuesday launched a new partnership to provide a growing number of UMB Health Savings Account holders direct access to eligible products for the tax-advantaged health plans.
The UMB HSA account access website provides a direct link to the customized HSA store on drugstore.com. Once there, account holders will have access to HSA-eligible products, services that automatically track purchases and provide an HSA-only receipt, and additional resources to help Consumer- Directed Healthcare Plan users record expenses for tax purposes. UMB HSA account holders will also receive special money-saving offers from drugstore.com, the companies reported.
“We’re pleased to work with UMB to provide their growing number of customers the convenience of shopping in one online location with a wide selection of more than 3,000 HSA-eligible, over-the-counter products as well as prescription medications and contact lenses,” stated David Lonczak, vice president and chief marketing officer, drugstore.com. “Unlike brick-and-mortar stores, the online retail environment is uniquely qualified to provide a convenient solution with eligible products as well as record keeping services for HSA account holders.”
UMB Healthcare’s HSA accounts grew even faster than the national average last year, according to the health insurer, surpassing $100 million in assets at the end of 2007.
The number of people with HSA/High Deductible Healthcare Plan coverage rose to 6.1 million in January 2008, a 35 percent increase over the previous year. In January 2007 there were 4.5 million people with HSAs and HDHPs and 3.2 million in January 2006, according to America’s Health Insurance Plans.
“UMB Healthcare HSA accounts give customers the opportunity to take control of their healthcare dollars while also saving money,” stated Dennis Triplett, president of UMB Healthcare Services. “The partnership with drugstore.com provides a great customer benefit, as it offers our account holders a convenient and streamlined process for managing their health care purchases.”
In addition to HSA accounts, UMB supports Flexible Spending Accounts and Health Reimbursement Arrangements (HRAs). UMB Healthcare Services was one of the first financial partners to provide multi-purpose card technology to the health care industry and recently developed a Healthcare Line of Credit product.