13 Key USP Progesterone cream items to consider before using:
I know you will agree with me when I tell you that putting the highest quality USP progesterone cream on your skin is very important.
The problem that I have found researching USP progesterone cream is that it that since the adoption of the USP – United States Pharmacopeia (standard quality practice for medicines) manufacturers are not required to adhere to quality standards unless they label their products as USP.
And most progesterone cream manufacturers are not willing to adopt the USP practice for fear of regulation.
I have helped guide hundreds of women towards the best progesterone cream for their bodies. Our clinic has helped hundreds of women work through hormone balance issues, seek relief from menopause, perimenopause, thyroid issues, and hysterectomies, etc.
We have helped turn once desperate and frustrated women into happy, loving, productive, sexually active, stress-free women and more.
In this post, I am going to teach you all about USP progesterone cream, why it’s important, how to use it and what to look out for.
#1: USP progesterone cream
— Androgenix Solutions (@AndrogenixHRT) November 16, 2018
USP progesterone cream is progesterone cream that meets a certain standard set by the United States Pharmacopeia. Essentially it means that the ingredients in the cream have the same hormones that exist in the human body.
Natural USP progesterone cream is an exact match, i.e., it is bioidentical to human progesterone made by the body and is not synthetic like ‘progestins’ manufactured and sold by pharmaceutical companies.
For instance, when women have taken progestins in the past, there have been reported cases of birth defects, where progesterone is needed for a healthy pregnancy. Since supplementing with USP progesterone cream is considered a natural hormone, the body can use it and dispose of it as needed.
Synthetic progestins are not processed well by the body and can have undesirable side effects.
USP is shortened for the term ‘United States Pharmacopeia.’ There are essentially three tiers or grades of materials under the USP designation, they are as follows; ‘USP pharmaceutical grade,’ ‘food grade’ – for human consumption, and ‘feed grade’ – for animals and not for human consumption.
Essentially these grades are based on quality and purity with the ones labeled ‘USP pharmaceutical grade’ consisting of the highest quality and standards.
USP progesterone cream is used for hormone replacement therapy and is of the highest quality and purity.
It comes from plant fats and oils extracted from the Mexican wild yam plant. The substance that derived from wild yams usually is ‘diosgenin.’
#2: Harvard-trained hormone pioneer Dr. John Lee M.D
The female hormone, produced by the corpus luteum after ovulation, that prepares the uterine lining for implantation of a fertilized egg and helps maintain the pregnancy. https://t.co/I2XjeJ3OL9 pic.twitter.com/8LdwnzIjBO
— JR Women’s Health (@JRWomansHealth) November 25, 2018
Harvard-trained physician Dr. John R. Lee has written extensively about the vital role progesterone plays in human health in his book, ‘What your doctor may not tell you about menopause.’
According to Dr. Lee, the most convenient and effective form of USP progesterone to use is natural USP progesterone cream which can be absorbed through the skin, sometimes called micronized progesterone cream or bioidentical progesterone cream.
USP progesterone cream should contain 2-3% USP natural progesterone by volume or 450-500 mg per ounce of cream.
#3: Natural progesterone replacement therapy
Natural or bioidentical progesterone therapy is designed to mimic the progesterone that is produced naturally by the human body.
It should re-create what your body produces while you are ovulating, the timing and the amount of progesterone produced.
When supplementing with USP progesterone cream, you want to ‘time’ the usage to be the same as it would be in your regular monthly menstrual cycle.
#4: How much USP progesterone cream to use
#Progesterone is usually depicted as a second bump about the same size as estrogen’s pre-ovulation surge (top image). But we actually make far MORE progesterone than we do estrogen (bottom image).
— Lara Briden, ND (@LaraBriden) November 19, 2018
You may notice that the labels on USP progesterone cream may list specific usage instructions. However, Dr. Lee recommends using 1/4 teaspoon once or twice a day for 2-3 weeks a month.
Using it in this way should simulate usual progesterone presence in the body. What this means is that about 1/4 teaspoon daily would provide approximately 20 mg/day.
However, Dr. Lee recommends that women not use higher than the recommended dosage to avoid hormone imbalances.
More is not better when it comes to hormone balance.
A side note: when women are pregnant they can produce as much as 400-500 mg of progesterone per day so overdosing is unlikely but not impossible.
#5: When to use USP progesterone cream
When do you use it? For premenopausal women, Dr. Lee recommends about 15-24 mg per day for 14 days before expected menses, stopping the day or so before your period begins.
For postmenopausal women, Dr. Lee suggests the dose that often works well is 15 mg per day for 25 days of each calendar month.
#6: Where to use USP progesterone cream
The best practice is to use progesterone cream on the soft parts of the skin such as inner arms – bicep and underarms, back of knees, stomach (if you are not obese or fat), face, neck, and breast.
Progesterone is absorbed into the capillaries and is fat soluble, meaning that it can stay into the fat and not assimilate. It’s best not to rub USP progesterone cream on places where you carry excess fat, if possible
It’s always a good idea to do your research and learn as much as you can about the role progesterone plays in your health and the potential health problems that can arise from overuse or underuse.
More and more women are taking an active role in their health and are now becoming enlightened to the fact that synthetics are not as safe as natural micronized progesterone or USP progesterone and natural estrogen supplementation as treatments for hormone imbalance.
#7: Dr. John Lee’s suggestions
Dr. John Lee pioneer on female hormone replacement suggests that you remain cautious of the fact that different UPS progesterone creams contain varying amounts of USP progesterone.
What this means is that you need may need to adjust the amount of cream you use to achieve the dosage Dr. Lee recommends.
In his books, Dr. Lee based his dosage recommendations on creams that contain 450 to 500 milligrams of USP Natural Progesterone per ounce.
I would encourage you to email or call the companies and ask how many milligrams per ounce they put in their creams so that you can adjust how much cream you use.
#8: The United States Pharmacopeia convention
The United States Pharmacopeia Convention (USP) is a 200-year-old nonprofit scientific organization founded in 1820 in Washington, D.C. that sets quality standards for medicines, dietary supplements, and food ingredients.
USP’s mission is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”
USP’s primary compendia of standards are the United States Pharmacopeia and the National Formulary (USP–NF).
USP standards may be adapted or adopted by any organization or government worldwide. USP has no role in enforcement; that is left to FDA and other government authorities in the U.S. and elsewhere
#9: What does compliance with USP–NF standards mean?
According to the USP’s website, compliance for the USP-NT standards mean, an article of commerce is an article recognized in the USP–NF that complies with USP–NF standards. When it meets all of the requirements stated in the article’s monograph, applicable General Chapters, and the General Notices (with monograph requirements superseding those of the General Chapters and General Notices, in any cases where requirements differ).
Applicable standards apply at all times in the life of an article, from production to expiration.
Thus, any official article is expected to meet the compendial standards if tested, and any official article actually tested as directed in the relevant monograph must meet such standards to demonstrate compliance.
The frequency of testing and sampling is left to the preferences or direction of those performing compliance testing, and other users of USP–NF, including manufacturers, buyers, or regulatory authorities. (General Notices, section 3.10)
#10: What is the role of USP standards in federal law?
Congress has consistently provided a role for USP standards in the adulteration and misbranding provisions of successive federal food and drug legislation, beginning with the Pure Food and Drugs act of 1906 and continuing to today with the Federal Food, Drug, and Cosmetic Act (FDCA).
Under Federal law, a drug with a name recognized in USP–NF must comply with the current version of compendial standards deemed official by USP, or risk is being deemed adulterated, misbranded, or both (FDCA 501(b) and 502(e)(3)(b); FDA regulations 21 CFR 299.5 (a&b)).
Biologics, including those approved by FDA under the Public Health Service (PHS) Act, are also considered drugs subject to the FDCA adulteration and misbranding provisions, including USP standards (FDCA 201(g), 301(a-c), and PHS Act 351(j).
Drugs and biologics recognized in USP must comply with identity standards; and must also comply with standards for strength, quality, and purity, unless labeled to show all respects in which the drug differs (FDCA 501(b); 21 CFR 299.5(c)).
Also (as exemplified by the ferrules and cap overseals labeling standard), to avoid being deemed misbranded, drugs recognized in USP–NF must also be packaged and labeled in compliance with compendial standards (FDCA 502(g)).
With regard to dietary supplements (regulated separately under the Dietary Supplement Health and Education Act, DSHEA), a dietary supplement that is covered by specifications in the USP–NF. It is represented as conforming to those specifications shall be deemed to be misbranded if it fails to so conform. See FDCA Section 403(s(2)(D)
#11: USP progesterone cream labeling
If you were to notice a label on a prescription or other medical product that has the letters ‘USP’ this means that it represents one of The United States earliest public health and safety measures.
This is a practice that dates back to the earliest days of democracy – well before the U.S. Food and Drug Administration (FDA) formed.
From the earliest colonial times in America, medicine practiced by apothecaries, blacksmiths, midwives and others tried their versions of known treatments. Some worked great while others were either very dangerous or had no effects.
#12: Professional doctors
In 1765 the first medical school was formed in the United States located in Philadelphia.
Initially medical doctors of the time diagnosed the disease as well as compounded and dispensed medicine much like what a naturopathic doctor or functional medicine doctor would try to do today with the exception of custom compounding.
Custom compounding of medicines and supplements left to compounding pharmacies, are generally from a written prescription from a medical provider.
Even though these doctors of the past were trained and educated correctly how to disperse medicines, there was no way to make sure that they were correctly made and contained the highest quality ingredients and strengths.
Founder of the medical college, John Morgan and even Benjamin Franklin spoke about the need for standards of medicine and pharmacology.
In 1820, part of their dream became a reality with the publication of the first ‘United States Pharmacopeia.’
The U.S. Pharmacopeia is a reference of uniform preparations for the most commonly used drugs—with tests to ensure their quality, potency, and purity.
Soon after, the pharmacy business grew, and medicines were made not only by the pharmacist but by commercial entrepreneur’s.
Companies like Eli Lily began to include “U.S.P.” on their product labels to indicate to pharmacists, medical practitioners and patients that their products are made by the quality standards of the United States Pharmacopeia – USP.
These three letters convey a great deal of information to the healthcare practitioner. They let the pharmacist or doctor know that the medicine or product in the container meets several key quality attributes that are necessary to ensure the medication will perform as expected.
Here are the USP standards:
- Identity–is the product what it claims to be
- Potency–is it present in the right amount
- Purity–is it free from impurities, contaminants or other unwanted ingredients
- Performance–will it dissolve and disintegrate in the body so the active ingredient can be absorbed
#13: Drug history:
The food and drug act became law in 1906, signed by President Theodore Roosevelt. This law began the food and drug administration and created public awareness of the USP – United States Pharmacopeia or the National Formulary (NF).
Degraded (lesser) drugs were defined as those referenced in the USP or NF but differed from ‘standard strength, quality or purity.
More and more the practice of labeling medicines ‘USP’ or “U.S.P’ became the norm.
Later in the Century, in 1938 the ‘Food, Drug and Cosmetic Act’ was added to the pharmacopeia to include standards for labeling and packaging.
Today, drugs sold in the United States are required to meet USP standards regardless of whether they include the letters “USP” on the label.
You may find some popular medicines or topicals such as ‘hydrogen peroxide” will have the USP printed on the label. What this means is that it was manufactured to meet quality USP standards.
Supplements, however, are judged to a different standard.
In 1994 the DSHEA – ‘Dietary Supplement Health and Education Act’ was passed. This was supposed to help regulate natural health products (supplements), however, unlike drugs, supplement manufacturers did not need to prove their product was safe or effective to sell them.
It is the choice of the supplement manufacturer whether they want to follow USP standards and includes the USP on the label or not. Some do, and some don’t.
What this means is that if they choose to label products as USP and don’t meet the standards, there could be consequences by regulatory enforcers.
So due to this practice, there seemed to be less incentive to label products with USP. Therefore, the FDA would have no jurisdiction over their manufacturing process.
Because of this FDA practice and most manufacturers choosing not to label products USP, it became difficult for pharmacists, healthcare practitioners or consumers to know if a dietary supplement were produced with the quality required by the USP.
USP progesterone cream is the highest quality progesterone you can buy according to the standards set out the United States Pharmacopeia. This does not mean you can not find other high-quality bioidentical or micronized progesterone creams on the market.
It is up to you to research and identify brands and products that fit the standards you want for your health care needs.
Tune in for actionable advice on topics like the 9 top bioidentical progesterone cream things to know, micronized progesterone, wild yam progesterone cream, and progesterone dominance tips and symptoms.