What Are “Pharmaceutical-Grade” Supplements?


You may have noticed the term “pharmaceutical-grade” used to describe the vitamins and supplements available at Dr. Randolph’s Pharmacy and Wellness Store. But what does it mean?

Vitamins and supplements are not regulated by the FDA like food and drugs. There is a wide variation in quality among supplements! Unfortunately, many vitamins and supplements sold in chain health food stores, big box stores, and grocery stores do not contain the ingredients listed on the bottle. (See our 2015 Press Release for more.) However, vitamins and supplements can be highly effective to support the restoration of hormonal balance, the revitalization of energy, and the normalization of many important bodily functions. We choose to offer only “pharmaceutical-grade” products because they provide our patients and customers with the highest *verifiable* quality and efficacy. The difference is significant. With high demand (more than half of people in the U.S. take some kind of dietary supplement), and minimal oversight of a $30+ billion-dollar industry, it is critical to feel confident in the quality of the supplements you take.

These are Dr. Randolph’s criteria for every product we offer:

(1) All ingredients meet U.S. Pharmacopeia standards. The USP establishes standards for medicines, food ingredients, and dietary supplement products that are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency. Don’t settle for anything less.
(2) Each manufacturer should perform extensive in-house testing. This means that they test all raw materials when they arrive for identity and purity, then test again when the finished product is complete. They should also do “stability testing” to ensure that products do not lose efficacy before the expiration date.
(3) Each manufacturer uses a third-party verification system. This means that the manufacturer invites the FDA and third-party auditors to review their manufacturing processes. It is an added layer of security beyond any strict in-house procedures.
(4) Intended use of product is established in medical literature or current research. Historical use is one thing to consider, but a universally reliable basis for using any ingredient is well-controlled human clinical trials published in peer-reviewed medical journals.