We receive daily emails from women looking to source a quality progesterone cream but who are unsure how to go about it.
The questions asked tend to focus on the following areas of concern:
- What creams are available to me locally?
- Do I need a doctor’s prescription to lawfully access cream?
- What if I cannot find a healthcare professional to support me?
- Do different countries have different laws about accessing progesterone?
- If I cannot find a cream locally, am I allowed to import from overseas?
- Are creams available on the shelf in a local healthfood store the “real thing”?
- Where you buy a premium progesterone cream/lotion
Australian Drug Law
The importation of progesterone cream into Australia is PERMITTED for personal use only.
In order words, women can legally import biodientical progesterone creams for personal use under the Australian Therapeutic Goods Administration (TGA) Personal Importation Scheme.
Personal importation occurs when:
- an individual arranges from within Australia for progesterone cream to be sent to them from an overseas supplier or family/friend; and
- progesterone cream is to be used by that individual or a member of his/her immediate family and is not sold or supplied to any other person.
All therapeutic drugs and products in Australia must first pass through the TGA. The TGA, a Government body established to screen and approve drugs / products intended for the market place, exists to protect the general public. Even natural products such as vitamins found in your local supermarket must apply for registration through the TGA. Further, any therapeutic claim associated with products sold over the counter must first be approved by the TGA.
The TGA notes in its Personal Imporation Scheme that such therapeutic goods like bioidentical progesterone may not be approved for supply in Australia; this means there are no guarantees about its safety or quality. In other words, the quality and efficacy of any progesterone you import is YOUR responsibility. So you’re going to have to do your homework!
Distribution of progesterone cream is illegal beyond family & friends.
So you DON’T need a doctor’s prescription to source cream. We’ve established that. However, let’s just explore for a moment the resons WHY women are sourcing their cream online.
In Australia, progesterone is classified an S4 drug, meaning it’s a prescription only medicine. To buy a progesterone cream via your local compounding pharmacy you will require a doctor’s cooperation to get a prescription. But here’s the rub! The Australian RX Drug Guide written by Dr. Jonathon Upfal does not list bioidentical progesterone, only artificial progestin analogs. The irony here is, even though classified as a “drug”, the large majority of doctors are unlikely (or unwilling) to prescribe natural progesterone because they know little or nothing of its applications.
Add to this mix the fact only a select number of pharmacies in Australia are skilled to compound progesterone cream, and it’s this limited supply that forces the cost of cream through the roof, it’s simply not a sound financial decision to buy locally. When you add up the doctor’s consult fee (to get your prescription) and the exorbitant cost of a compounded cream (AUS$70> per jar), no surprise why women opt to import their progesterone cream in from overseas.
Similar ‘complexities’ exist in countries like the UK, Canada, and New Zealand (all members of the British Commonwealth of Nations).
NOTE: Any product currently available on the shelf in a healthfood store or via a MLM distributor would be exclusively a Wild Yam Extract cream containing NO micronised progesterone.
USA Drug Law
Bioidentical progesterone creams can be legally sourced through whatever channels available – over the counter, via marketing distributors, or on-line over the internet – for progesterone has been used safely in women?s cosmetics and moisturisers in the United States for years. Therefore, for the time being anyway, a US drug law does not apply to progesterone supply and usage.
That said, in California under the State’s Proposition 65, progesterone creams manufactured and/or distributed in California are required by law to carry a warning on all labels as follows:
“WARNING: This Product Contains A Chemical Known To The State of California To Cause Cancer.”
There have been rumblings that America’s Food & Drug Administration (FDA) may impose changes to current drug law, restricting ad-hoc marketing of creams. The consequence of this decision will possibly push distribution underground and compromise the manufacture of quality controlled progesterone creams.
So, for the time being anyway, premium natural progesterone creams delivering 20mg per application can be legally sourced over the counter in America. You DO NOT require a doctor’s prescription.
Know What You Are Buying
If there is a down’ side to this ‘easy access’ it’s the lack of quality control imposed on progesterone cream manufacturers.
In the United States progesterone in a cream base is classified a cosmetic as long as the manufacturing company makes no therapeutic claims for their products. This is why most commercially produced creams are called body creams or lotions. Any claims about effects on hormone imbalance symptoms tend to be very generalized and “ambiguous” so as not to incur the wrath of the FDA . Third party claims via websites or advertising material is at arms length from manufacturers and therefore claims often represent progesterone as being the “magic bullet” for all types of ailments.
Because of the cosmetic status of commercially produced creams, adherence to Good Manufacturing Practice (GMP) is not regulated in the same way as the pharmaceutical industry and, to a lesser extent, the “compounding pharmacy” industry. Labeling requirements on cosmetics is also variable and the amount of progesterone actually in a preparation does not need to be stated.
Labeling on some preparations available in the USA can often border on deception.
USP or BP grade progesterone means that the progesterone used meets United States Pharmacopeia or British Pharmacopeia standards which is extremely high quality.
A “trusted” compounding pharmacy will only use USP or BP standard active ingredients.
Dr John Lee highlighted the variation of products on the US market in his original book (page 269-272) ‘What Your Doctor May Not Tell You About Menopause’. He expanded on the original list in subsequent editions and books.
Any progesterone cream manufacturer or compounding pharmacy should be able to inform the user of the degree of micronisation of the progesterone that they use. They should hold on file a particle distribution profile for each batch of progesterone which they utilise. The absolute maximum particle size should be no greater than 20 microns. Further, they should likewise provide confirmation of the amount of progesterone in their preparation.
Different compounded products may vary in effectiveness depending upon the type of base used in the manufacture.
Information You Can Trust
The Natural-Progesterone-Advisory-Network.com is NOT in any way linked or associated with bio-identical progesterone pharmaceutical manufactures or distributors. We DO NOT sway to the influences of censors and sponsors. We DO NOT promote, advertise or sell any cream or product. We PROVIDE YOU WITH QUALITY AND UNBIASED information. In other words, we tell you like it is!
We are your ONE STOP RESOURCE for all and complete information on natural progesterone. With us, you don’t have to go anywhere else as we provide you quality articles by industry experts and medical professionals. We make recommendations, offer advisories, points out concerns and much more, to help you make the best decision without or under any influence.
Where to Buy Your Cream?
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