|
Editorial: Definitions
This is the tenth in our series presenting various aspects of the new H.R. 3204 law (also known as the Drug Quality and Security Act [DQSA]) as it relates to pharmacy compounding. This week, we will continue to look at the definitions in the bill, as they are the foundation for the bill and how the various components will be interpreted.
Approved drug: The term 'approved drug' means a drug that is approved under section 505 and does not appear on the list described in subsection (a)(4) of drugs that have been withdrawn or removed from the market because such drugs or components of such drug have been found to be unsafe or not effective.
There are two components to this definition; first, the drug is approved by the FDA under section 505 and, second, the approved drug cannot appear on the "negative list." Let's look further at the definition of a "drug" and "drug product" as they are used in Section 503A.
The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 403(r)(1)(B) and 403(r)(3) or sections 403(r)(1)(B) and 403(r)(5)(D), is made in accordance with the requirements of section 403(r) is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 403(r)(6) is not a drug under clause (C) solely because the label or the labeling contains such a statement.
"Drug product" means a finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.
Next week, we will continue with the use of these words and the new compounding law.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
|
|
ePASS Coming to Walgreens
Walgreens introduces their Electronic Patient Assessment Solution Suite (ePASS0-software that mines electronic health records to guide questioning during check-ups. Healthcare practitioners in Walgreens' clinics are starting to use ePASS to provide guided medical attention utilizing analytics software. Soon, hundreds of Walgreens' clinics will be using the new software that guides healthcare providers through checkups by asking certain questions or requesting particular lab tests depending on the patient's history.
When a patient arrives at a Walgreens' clinic, patients sign in at a computer kiosk and their names are fed into a list on a clinician's computer in an examination room. The software tailors questions to the patient's history from health records, and to conditions the patient is likely to have, based on an assessment of millions of other patients.
http://www.washingtonpost.com/business/on-it/walgreens-to-use-software-to-help-clinicians-assess-patients/2014/02/01/2ab7f0d2-89e1-11e3-916e-e01534b1e132_story.html
Wearable Healthcare Technology
It's here: wearable technology including smart devices such as a smart watch, a Fitbit fitness bracelet, a smart phone, an RFID badge, and a Google Glass eyepiece. A recent conference combined new technology and "Star Trek" references as a panel spoke to the advances in miniaturization, battery life, and wireless communication that have let wearable technology interweave into everyday life.
http://bluesky.chicagotribune.com/originals/chi-wearable-technology-health-bsi,0,0.story
Sicker Patients Needed in Clinical Trials
The FDA is initiating steps to include more patients with multiple chronic conditions in clinical trials of new drugs. They believe such patients are too frequently excluded from new drug studies. It is common for pharmaceutical companies to exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates; however, as a result, the studies don't provide a glimpse of the treatment's "real world" effect.
http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/44088
Transparency Lacking in FDA Rulemaking Process
It takes an average of 7.3 years to finalize rules that determine the regulation process. The Unified Agendas of Federal Regulatory and Deregulatory Actions and Regulatory Plans provide annual data on the rulemaking process. Between 2000 and 2012, there were 40 significant rules the agency issued, which were about 10 percent of all the FDA's medical product rules throughout those years. This study showed that only about 75 percent of public comments were available in electronic format for only four of the 40 rules and about half the comments came from industry. Based on their findings, the authors called for more transparency in the rulemaking process.
http://www.cardiovascularbusiness.com/topics/healthcare-economics/fda-rulemaking-process-lacks-transparency-efficiency
|
|
�that next Friday is Valentine's Day, which is celebrated in many countries throughout the world? It is celebrated by presenting flowers, candy, and greeting cards. Interesting that it has been, and still is, quite profitable to drug stores.
|
