Pharmaceutical Compounding.
Your Solution for Personalization. Your Opportunity for Improved Care.


Pharmaceutical compounding is defined as the practice of preparing customized medications, in accordance with a licensed practitioner’s prescription, to address a patient’s unique set of conditions, tolerances, and preferences where commercially available products are lacking. Pharmaceutical compounding allows providers the flexibility to address unmet needs such as:


Personalize Dosing
Prescribe therapeutically effective dosage strengths that are suitable to the patient without being limited to fixed dosing increments set by commercial products.
Tailor Dosage Forms
Choose a dosage form (gel, cream, lotion, ointment, solution, or other) based on physiochemical compatibility and stability with the active ingredient(s), therapeutic intent, application site, or patient preference.
Eliminate Unwanted Ingredients
Select ingredients that are well tolerated by the patient and avoid ingredients common in commercial therapeutics that a patient may be intolerant, sensitive, or allergic to.


Combine Therapeutics
Consider how active ingredients are best suited together and maximize treatment efficacy, tolerability, and safety. Reduce treatment regimen complexity and enhance patient adherence.
Enhance Compliance
Improve patient adherence by personalizing the medication to produce better therapeutic outcomes, reduce side effects, decrease complexity, or achieve patient preference.
Provide Solutions to Product Unavailability
Create solutions where the commercially available product is not available.


Know How It’s Regulated.


The State Board of Pharmacy

In the various states, the state's Board of Pharmacy is the primary regulator of pharmacies, including traditional (503A) compounding pharmacies. Each State Board of Pharmacy has written legislations that govern and legally hold compounding pharmacies accountable for all their operations, including compounding itself.

The United States Pharmacopeia (USP)

State Boards of Pharmacy typically adopt in full, in part, or adapted versions of the USP General Chapters that detail standards of practice. For compounding practices, the most noteworthy USP standards of practice are General Chapters USP <795> (Non-Sterile Compounding), USP <797> (Sterile Compounding), and USP <800> (Hazardous Drugs).

The Food and Drug Administration (FDA)

Under Federal law, the FDA has authority over pharmacy compounding and has issued policies on when compounding is appropriate, as well as on the standards for the production of compounded products. Under its authority, the FDA, typically in conjunction with the respective states, inspects compounding pharmacy facilities to ensure compliance with production standards mandated by the USP, and, in the case of outsourcing facilities, with Current Good Manufacturing Practice requirements.



Choose a Pharmacy that Meets and Exceeds Standards.


Continuing Education

Has the pharmacy personnel undergone appropriate Continuing Education training and do they have certificates to support this (e.g., hands-on non-sterile lab training, dermatology compounding training etc.)?

Quality Assurance & Control

Does the pharmacy have procedures in place for pharmacist verification, batch testing, ingredient testing, and employee testing in accordance with USP standards of practice General Chapter <1163> (Quality Control)?

Standard Operating Procedures

Does the pharmacy have current and compliant Standard Operating Procedures implemented to ensure a robust quality system is in place and compliance with standard of practice (USP <795>, <797>, <800>, <1163>)?

High Quality Ingredients

Does the pharmacy source high quality ingredients from suppliers with robust vendor qualification and testing programs ?

Innovative Technology

Does the pharmacy use innovative technology that ensures greater reproducibility, homogenous mixing, and better quality?



See What it Looks Like.


Efficacy, Safety, & Dosing.
Evidence-Based Medicine Starts Here.




Acne affects around 50 million people in the US alone (Zouboulis et al., 2014) and is associated with lower self esteem (Layton et al., 2004) and increased risk for depression, anxiety and suicide (Guay, 2007). Topical therapy is the most common form of treatment. When compounded therapies are appropriate for acne, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Aging is an inevitable physiological process (Manríquez et al., 2014). With emphasis on maintaining a youthful look, the demand for novel and/or customized therapeutics are rising higher, now more than ever (Manríquez et al., 2014). Compounding opportunities for wrinkles and aging cover tailored topical base selection, tailored ingredient selection, and unique combination and dosing of active ingredients and natural extracts with growing efficacy and safety evidence, including:

Alopecia management for some individuals is inconsistent and unreliable (Shapiro, 2002). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Dermatitis management with commercial therapeutics is estimated to not meet the needs of 10-15% of patients (Beiber, 2013). Patients with dermatitis are also reported to be more dissatisfied with current treatment options relative to other chronic diseases (Nakahara et al., 2019). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Hyperpigmentation therapy is often a slow process ranging 6-12 months (Schwartz et al., 2020). Combination formulas may enhance the success of desired outcomes when safely incorporating bleaching agents (Rigopoulos & Katoulis, 2018). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Psoriasis remains undertreated despite commercially available products, and 50% of patients report being dissatisfied with their treatment (Feldman et al., 2016; Koyama et al., 2015). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Rosacea affects 16 million people in the US and is associated with lower quality of life (Reinholz et al., 2016). Patients with rosacea often display a combination of symptoms, requiring a combination of treatment approaches (Mikkelsen et al., 2016). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Scars are a prevalent condition that can have a significant psychological effect (Bayat et al., 2003). In the US, the market for products to treat skin scarring is estimated at 12 billion USD (Han & Ceilley, 2017). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Wound management (including ulcers, burns, nipple fissures, anal fissures, and surgical wounds) is important for ensuring proper healing, avoiding adverse secondary effects (e.g., infections), and is the first step for reducing scar formation (Li et al., 2007). When compounded therapies are appropriate, choices need to be tailored to topical base selection, ingredient selection, and various and unique combinations and dosing of active ingredients for safety and efficacy, including:

Sample Formulas*.
Just the Beginning of Your Personalized Medicine Journey.



Compounded MedicationCompounding BaseClinical Reference(s)Formula Reference
Benzoyl Peroxide 5%, Clindamycin 1% Topical Gel VersaPro™ Gel Base Akarsu et al., 2012;
Seidler et al., 2010
F 006 875
Benzoyl Peroxide 5%, Clindamycin 1%, Salicylic Acid 5% Topical Lotion VersaPro™ Lotion Base Akarsu et al., 2012;
Seidler et al., 2010
F 008 881

* Presented for information and illustration purposes only.
Optimal Base. Optimal Delivery.
Why the Vehicle Matters.


A compounding base serves as a vehicle that carries and delivers the active ingredient(s) to the target site. Topical bases used in dermatology come in the form of creams, lotions, gels, ointments, shampoos, solutions, and foams. Base selection is a critical process pharmacists perform and should be understood by providers prescribing compounded medications. Notably, selecting a compounding base involves considering the following:


The first thing a pharmacist considers when selecting a base is the physiochemical compatibility of the active ingredient with the base. The chosen base must be able to hold the active ingredient without “breaking”. A gel that liquefies after adding the active ingredient would be an example of incompatibility. Noteworthy properties a pharmacist or technician will look for when selecting a base include:

  • Base compatibility with lipophilic vs. hydrophilic active ingredients (i.e., the solubility of active ingredient in the base).

  • Base compatibility with salt forms of the active ingredient.

  • Base compatibility with acids (e.g., salicylic acid).

  • Base compatibility with active ingredients with frequent incompatibilities (e.g., hydroquinone).

  • Base carrying capacity with consideration for the concentration or amount of active ingredient.
Sometimes confused with compatibility, stability refers to the extent to which a preparation retains, within its ‘shelf-life’, chemical, physical, microbiological, therapeutic, and toxicological stability (USP Compounding Expert Committee, 2014). Stability is determined through stability-indicating testing (e.g., HPLC with degradation). Many bases on the market have undergone stability-indicating testing for common formulas. Although not required to compound a medication, stability-indicating testing is an advantageous feature when selecting a base as it not only confirms stability, but it permits extended beyond-use dating (the “expiry date” assigned to a compounded preparation), which facilitates patient access. Below are sample study reports of stability-indicating studies conducted on common dermatological preparations:

  • Medisca. (2021). Stability assessment of compounded preparation – Bracketed Hydroquinone 2%-10% in HRT Cream Base. View Study Report>

  • Lupatini, R. Sidhu, R., Patel, H., & Bischar, K. (2021). Stability evaluation of minoxidil in FOAMIL foam base with bracketing study design. International Journal of Pharmaceutical Compounding, 25, 236-240. View Study Report>
Patient tolerance is of course pertinent when selecting the active ingredients, excipients, and base of a medication or formulation. Avoiding certain ingredients due to allergies or sensitivities is an advantage and reason alone for compounding. Patient preference to the type of vehicle (e.g., creams, gels, lotions) is also a factor, especially depending on where the patient is applying the preparation. A happy patient is a compliant patient.
Many compounding bases on the market today have functional properties, where the base is formulated with certain ingredients to facilitate certain effects that may be beneficial for the prescribed treatment regimen. These properties are invaluable and can add to the therapeutic effectiveness of a final compounded preparation. Noteworthy properties include:

  • Permeation ability. Permeation through the skin layers may be desired for the therapeutic outcome. Selecting a base with penetration enhancers or permeation data would be something a pharmacist would look for in this instance.

  • Moisturizing properties. This feature may be desired for a patient with known dry skin or to counter the drying effect of certain active ingredients.

  • Quick drying properties. This feature is typically desired at the patient level, for example patients with oily skin that want a quick drying formula with minimal to no residuals.

  • Antimicrobial properties. In dermatology, antimicrobial effects are often desired, for example in treating wounds or acne. Selecting a base containing antimicrobial agents or a base with data proving antimicrobial effectiveness would be advantageous.

  • Scar reducing properties. Compounding bases with known scar-reducing effects exist on the market. When treating scars, selecting a base with already existent scar-reducing properties is advantageous.

Industry-Leading Compounding Bases for Dermatological Care.


 VersaPro™ Cream BaseHRT Cream BaseVersaPro™ Lotion Base
Description White, shiny, medium viscosity, oil in water cream. Non-greasy, great vanishing properties. White, shiny, low viscosity, oil in water cream. Non-greasy, great vanishing properties. White, low viscosity, oil in water lotion. Non-greasy, great vanishing properties.
Recommended Use Cosmetic formulas due to its cosmetic elegance.

• Due to its moisturizing effects and non-comedogenic ingredients, this base may be recommended for acne, dry skin or conditions treated with active ingredients that have known drying effects, such as the case with acne and use of benzoyl peroxide, salicylic acid, and beta-hydroxy acid (Webster & Rawlings, 2007; Kessler et al., 2008) and rosacea and use of azelaic acid (Oge et al., 2015; Rivero & Whitfeld, 2018).

• Due to its good salt tolerance, this base may be recommended for formulas that contain active ingredient salt forms, which may be the case for anesthetic creams (Kumar et al., 2015)
Cosmetic formulas due to its cosmetic elegance.

• Due to its compatibility with hydroquinone and tretinoin, this compounding base may be recommended for formulas containing these ingredients, which may be recommended for hyperpigmentation or melasma (Rigopoulos & Katoulis, 2018), acne (Bayramgurler et al., 2017), rosacea (Freeman et al., 2012), aging (Mukherjee et al., 2006).

• Due to its high pH stability range, this base may be recommended when using certain acids.
• Due to its high pH stability range, this base may be recommended when using certain acids, such as salicylic acid, alpha-hydoxy acid, azelaic acid, and glycolic acid, which may be used for managing acne (Seidler & Kimball, 2010). rosacea (Rivero & Whitfeld, 2018) and aging (Bergfeld et al., 1997)

• Due to its cosmetic elegance this compounding base may be recommended for cosmetic & aging

• Due to its quicker drying effects, lotions tend to be preferred by men over creams and may be preferred by women when applying to the face and prefer quicker drying so the may apply makeup afterward.
Lipophilic Compatible
Hydrophilic Compatible
Cosmetically Elegant
HRIPT Tested
Free of parabens, Mineral Oil, & Fragrances
Contains Aloe Vera & Vitamin E
Suitable for Vaginal Use
Compatible with Salts x
Compatible with Acids Low*
Compatible with Hydroquinone x x
Excellent Permeation
Wide pH Stability
Other Features Proven 24-hour moisturizer. Non-comedogenic ingredients.

*May experience challenges with certain acids that can be corrected with pH adjustments and LiquidGel Complex™
Studies Stability-indicating study: Hydroquinone 2%-10% (Bracketed) >


Selecting a Device.
Control Delivery. Maintain Integrity.


A drug delivery device enables and can enhance the administration and/or introduction of an active ingredient to the body, with the potential to improve efficacy and safety by controlling the amount, use, and exposure of the drug during the administration process. In topical routes of administration for dermatological therapy, drug delivery devices, such as dispensers, are particularly important, as they require accurate dosing. When evaluating a delivery device for topical delivery, the below factors should be considered:

Metered Dispenser

  • Does the device accurately dose the medication (e.g., 0.1 mL, 0.5 mL, 1.0 mL) with good air evacuation and minimal priming?

Product Integrity

  • Does the device maintain product integrity and compatibility?
  • Does it protect from UV, oxidation, and bacterial contamination?

Patient Safety

  • Does the device ensure patient safety by reducing exposure to hazardous drugs and being free of latex, BPA, and PVC, among more?

Consumer Demand

  • Does the device meet consumer demands – is it cosmetically elegant, easy to use, easy to transport?


How to Write a Compounded Prescription.
When Personalized Prescription is Appropriate.


Medication Type

Compounded medication is the medication type.

Drug Name & Strength

Indicate the chemical name of the active ingredient(s), not the trademarked brand name. All individual drugs must be listed, and avoid common or proprietary names (e.g., Magic Mouthwash). Include desired strength, concentration, or percentage of the active ingredient(s).

Dosage Form

Indicate the desired dosage form (e.g., cream, gel, ointment, shampoo, foam, etc.).

Base

When applicable, indicate the desired base.

Direction for Use

Indicate the desired treatment regimen.

Quantity

Include the desired dispensing quantity and any desired refills. Ask your pharmacist about beyond-use dates (BUDs).

Patient-Specific Special Considerations

Describe the need for the compounded medication; the patient-specific considerations that require a compounded medication, such as excipient requirements (e.g., dye allergy, sugar-free, etc.).

Continuing Education.
Learn When Compounding is Appropriate.


Learn from renowned leaders in personalized dermatology therapy - Aaron Sihota and Dr. Mindy Cormier - at LP3 Network's Dermatology Seminar events. Attend together with your compounding pharmacist and save. Improved patient care starts with collaborative efforts between providers and continued education.


Personalized Dermatology: Clinical and Cosmetic Care


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