NABP e-News: April 16, 2008

Senate Passes Bill to Restrict Distribution of Controlled Substances through Internet Pharmacies
On April 1, 2008, the United States Senate passed the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 to impose registration and reporting requirements on Internet pharmacies that dispense controlled substances. Under the proposed legislation, an Internet pharmacy must:

  1. post on its home page a statement of its compliance with this act;
  2. comply with licensure requirements in each state in which it operates and with all applicable federal and state laws;
  3. post on its home page certain information about the business owner, a list of the states in which it operates and is licensed, and certain information about the location of the pharmacy, the qualifications of its pharmacist-in-charge and practitioners who provide medical consultations, and a certification of its registration; and
  4. notify the Attorney General and applicable state boards of pharmacy prior to offering to dispense controlled substances.

The bill also prohibits an Internet pharmacy from selling a controlled substance without a valid prescription, and establishes criminal penalties for violating this act. The bill is now referred to the House Energy and Commerce and Judiciary committees and is posted on the Library of Congress Web site at http://thomas.loc.gov.

ISMP Recommends Guidelines for Safe Use of Automated Dispensing Cabinets
The Institute for Safe Medication Practices (ISMP) has released new guidelines to encourage the safe use of automated dispensing cabinets (ADCs). Most hospitals and many outpatient facilities use these computerized drug storage devices to store and dispense medications near the point of care, while controlling and tracking drug distribution. ISMP held a national ADC forum in March 2007 that included pharmacists, nurses, vendors, and others, to develop interdisciplinary guidelines that focused on a collaborative approach to safe medication use. The resulting “Guidelines for Safe Use of Automated Dispensing Cabinets” covers 12 processes, such as ensuring ADC system security and establishing criteria for ADC system overrides. These guidelines, available on the ISMP Web site at www.ismp.org/Tools/guidelines/ADC_Guidelines_Final.pdf, are intended to be universally incorporated into practice, in an effort to promote safe ADC use and subsequently to improve patient safety.

AMA Issues Policy on Unapproved Compounded Medications
American Medical Association (AMA) has issued a policy regarding compounded medications that are not approved by Food and Drug Administration (FDA). The policy states that AMA:

  • recognizes that compounding pharmacies must comply with current United States Pharmacopeia and National Formulary (USP-NF) compounding monographs, when available, and recommends that they be required to conform with USP-NF General Chapters on pharmaceutical compounding to ensure the uniformity, quality, and safety of compounded medications;
  • recognizes the Pharmacy Compounding Accreditation Board (PCAB™) accreditation program and Seal of Accreditation as a means to identify compounding pharmacies that adhere to quality and practice standards for the preparation of individualized medications for specific patients;
  • encourages all state boards of pharmacy to require compounding pharmacies in their states to obtain the PCAB Seal of Accreditation or comparable approved certification; and
  • encourages the boards and NABP to work with FDA to identify and take appropriate enforcement actions against entities that are illegally manufacturing medications under the guise of pharmacy compounding.

Two Additional Facilities Awarded VAWD Accreditation
NABP recently accredited two new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®)program, bringing the total number of accredited facilities to 263 as of April 11, 2008. A full listing of VAWD facilities is available under Accreditation Programs on the NABP Web site.

  • MWI Veterinary Supply Company distributes veterinary medical supplies, prescription products, and over-the-counter drugs to veterinarians and animal hospitals throughout the northwestern states. The company received accreditation for its Nampa, ID facility.
  • Phoenix Pharmaceutical, Inc distributes case lots of veterinary products, including Schedule III and IV controlled substances, to other veterinary distributors. The company received accreditation for its Joseph, MO facility.

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