CFR Compliance LLC
Compliance, Regulatory & Quality Consultants
What We Do (scroll down)
HEALTHCARE COMPLIANCE
The Office of Investigator General (OIG) and the Department of Justice (DOJ), expects hospitals, nursing homes, third-party billers, and durable medical equipment suppliers, to develop and follow internal controls that ensure compliance to existing statutes and regulations. Particularly, by any healthcare operation funded by federal programs such as Medicare/Medicaid. Both, OIG and DOJ enforce these requirements to prevent fraud that would eventually affect patient safety and the government interest.
DRUGS / BIOLOGICS
A drug is any substance (except food and water) that, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body.
Drugs can either be synthesized by chemistry reaction, or semi-synthesized from biological sources, which in that case are known as biologics.
COMPOUNDING PHARMACIES
Similar to drug companies, the compounding pharmacies specialize in the manufacturing of substances (except food and water) which, when inhaled, injected, smoked, consumed, absorbed via a patch on the skin, or dissolved under the tongue causes a physiological change in the body.
TOBACCO / HEMP / CBD
FDA's traditional "safe and effective" standard for evaluating medical products does not apply to tobacco products. The FDA evaluates new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole, including users, nonusers, initiation and cessation.
On the other hand, products related to cannabinoids are exposed to a different regulatory burden that depends on whether it is derived from hemp and its THC levels. Not only are they regulated by the FDA, but most states have enacted regulations that are enforced for the taxation, use, and even medical prescription; such as the case for medical marijuana.
ANIMAL / VETERINARY
The mission statement for FDA’s Center for Veterinary Medicine (CVM) reads: “Protecting Human and Animal Health.” To achieve this broad mission, CVM makes sure an animal drug is safe and effective before approving it. The center approves animal drugs for companion (pet) animals, such as dogs, cats, and horses; and for food-producing animals, such as cattle, pigs, and chickens. If the drug is for a food-producing animal, before approving it, the center also makes sure that food products made from treated animals (e.g. meat, milk, and eggs) are safe for people to eat. The CVM also Makes sure food for animals—which includes animal feed, pet food, and pet treats—is safe, made under sanitary conditions, and properly labeled.
TRAINING / SPEAKING
Training is teaching, or developing in oneself or others, any skills and knowledge or fitness that relate to specific useful competencies. Training has specific goals of improving one's capability, capacity, productivity and performance.
STATE LICENSING
While the FDA regulates and preempts the field regarding the manufacturing and distribution of drugs and other healthcare products within the US stream of commerce; some US states have also decided to regulate the distribution within its state borders in a complementary approach to the FDA.
MEDICAL DEVICES
A medical device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or other condition.
LABORATORIES (CLIA)
A “laboratory” or “clinical laboratory” means any facility for the biological, microbiological, serological, chemical, immune, hematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body to provide information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.
FOOD / AGRICULTURE
The food regulation ensures that its control, safety and relevant aspects of the food trade are safe. That includes the total chain beginning with provisions for animal feed, on-farm controls and early processing through to final distribution and use by the consumer. In the USA, this is accomplished by the joint enforcement of FDA, USDA, and FTC. For example, it is not rare to find a food product that is regulated by the three agencies based on its production and marketing.
COSMETICS / SUPPLEMENTS
A dietary supplement is a product intended for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances: a vitamin. a mineral. an herb or other botanical. FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
CONSUMER PRODUCTS
The term ‘‘consumer product’’ means any article, component or part thereof, produced or distributed (i) for sale to a consumer for use in or around a permanent or temporary household or residence, a school, in recreation, or otherwise, or (ii) for the personal use, consumption or enjoyment of a consumer in or around a permanent or temporary household or residence, a school, and in
recreation.
EXPERT WITNESS
An expert witness is a person whose opinion by virtue of education, training, certification, skills or experience, is accepted by the judge as an expert in a subject within a trial. The judge may consider the witness's specialized opinion about evidence or about facts before the court within the expert's area of expertise.