NABP e-News: October 29, 2008

October 29, 2008 12:00 AM

FDA Issues Final Rule Requiring Toll-Free Number on Medication Labeling
Food and Drug Administration (FDA) has issued a final rule requiring the labeling for certain medications to include a toll-free number for patients to report side effects. The final rule confirms the interim final rule “Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products” and its requirement for the addition of a statement to the labeling for certain human drug products for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act. The statement must include a toll-free number and advise that the number is to be used only for reporting side effects and is not intended for medical advice. This final rule also affirms the interim final rule’s addition of a new part 209 to the regulations requiring distribution of the side effects statement. This final rule implements provisions of the Best Pharmaceuticals for Children Act (Public Law 107-109) and the Food and Dug Administration Amendments Act of 2007. The final rule is effective November 28, 2008, and the compliance date is July 1, 2009. More information is available in the Federal Register [Docket No. FDA–2003–N–0313 ].

President Bush Signs Ryan Haight Act, Cracks Down on Internet Drug Outlets
President Bush signed into law House of Representatives (HR) Bill 6353, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 on October 15, 2008. Now known as Public Law No. 110-425, the new law amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. The law defines "valid prescription" as one issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. The legislation also adds definitions to the Controlled Substances Act relating to online pharmacies and the issuance of prescriptions over the Internet, imposes registration and reporting requirements on online pharmacies, and increases criminal penalties involving Sch edule III, IV, and V controlled substances. The law also authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents.

Methamphetamine Production Prevention Act of 2008 Signed into Law
President Bush signed into law Senate (S) Bill 1276, the Methamphetamine Production Prevention Act of 2008, on October 14, 2008. Now known as Public Law No. 110-415, the legislation revises the logbook requirements of the federal Combat Methamphetamine Epidemic Act, enacted in 2006, which limits the amount of methamphetamine precursor drugs, such as pseudoephedrine, that a patient can buy and requires pharmacies to keep written or electronic logbooks recording each purchase of the drugs. The new law changes the earlier act to facilitate the use of electronic logbooks instead of written logbooks and provides grants to accomplish this goal. The new system is intended to provide law enforcement with easier access to information and streamline recordkeeping requirements for pharmacies.

FDA Creates Web Page with Medication Safety Information for Patients, Professionals
Patients and health care professionals can now go to a single page on the Food and Drug Administration (FDA) Web site to find a wide variety of safety information about prescription medications. The Web page provides links to information on drug labeling; drugs that have a Risk Evaluation and Mitigation Strategy to ensure that their benefits outweigh their risks; post-market studies of drugs’ safety, efficacy, or optimal use; clinical trials; drug-specific safety information; warning letters; and consumer articles. Establishing such a Web page is one of the requirements of the Food and Drug Administration Amendments Act of 2007 and is among FDA's efforts to address the safe use of medications throughout their lifecycle. FDA recently launched another Web page that provides information on risks involved in using unapproved drugs. The new page has sections tailored to the interests of health care professionals, patients, and industry audiences, as well as links to general information for all audiences.

Four Additional Pharmacies Awarded DMEPOS Accreditation
NABP recently accredited four additional pharmacies through its durable medical equipment prosthetics, orthotics, and supplies (DMEPOS) program, bringing the total number of accredited pharmacies to 43 as of October 24, 2008. A full listing of DMEPOS-accredited pharmacies is available under Accreditation Programs on the NABP Web site.

• Beans Pharmacy, Washington, IA, has been in business for 30 years. It provides traditional retail pharmacy services to a large population of Medicare beneficiaries. The pharmacy is under new ownership as of April 2008.
• Becker Professional Pharmacy, Chicago, IL, has been in existence at the present location since 1943. The pharmacy offers bilingual assistance for its Romanian clientele.
• Calmont Pharmacy, Stockton, CA, provides service primarily to Medicare and Medicaid beneficiaries. Under the current ownership since 1988, the pharmacy moved to its present location in 2004, retaining approximately 70% of its patients after the move.
• Yee’s Prescription Pharmacy, Long Beach, CA, has been owned and operated by the Yee family for 38 years. Yee’s provides traditional retail pharmacy services to a population mixed in age and ethnicity, and offers bilingual assistance for its Hispanic clientele.