Pain Provider Information

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 (capsule, cream, gel, suppository, 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 medication products that a patient may be intolerant, sensitive, or allergic to.

Combine Multiple Ingredients

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, target pain at its source, reduce side effects, decrease regimen complexity, and help meet patient preferences.

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, pain management 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>)?

Quality Supply

Does the pharmacy source high quality ingredients that meet pharmacopeia 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.

Anal fissures primarily present with anal pain, and first-line therapy includes topical ointments and creams (typically with conservative management such as increased fiber intake) to promote healing and to reduce the pain (Salati, 2021; Stewart et al., 2017). When compounded therapies are appropriate, compounding opportunities for anal fissure pain include topical options and tailored dosing of active ingredients covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Fibromyalgia has an estimated global prevalence of 1–5% (Tzadok & Ablin, 2020). Despite the availability of medication indicated for this pain disorder, rates of success have been modest and fewer patients have remained on their treatment due to low compliance (Tzadok & Ablin, 2020). When compounded therapies are appropriate, compounding opportunities for fibromyalgia include oral options and tailored dosing covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Migraine is a primary headache disorder, globally affecting adults predominantly between 35 and 45 years of age, with a higher prevalence in women (The WHO, 2016). While preventive treatment (e.g., with antidepressants) can be a highly valuable strategy, it is often underutilized (Martin et al., 2021). When compounded therapies are appropriate, compounding opportunities for migraine include topical options and tailored dosing covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Musculoskeletal and soft tissue pain account for one of the most common complaints at primary care visits, and their management, particularly if chronic, represents a daily challenge in this setting, mainly due to incomplete relief or only short-lasting pain relief with commercially available treatments (Hubbard et al., 2018; Ren, 2020). When compounded therapies are appropriate, compounding opportunities include topical options and tailored dosing of common active ingredients covering different mechanisms of action used to treat musculoskeletal and soft tissue pain. Explore efficacy, safety, and dosing evidence below:

Neuropathic pain is estimated to affect between approximately 7–10% of the general population, and its management typically centers on treating its symptoms rather than the cause; however, limited efficacy of currently available pharmacological approaches have rendered its management challenging (Colloca et al., 2017; van Hecke et al., 2014). When compounded therapies are appropriate, compounding opportunities for neuropathic pain include topical options and tailored dosing covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Oral mucositis, mouth ulcers, and burning mouth syndrome represent acute or chronic oral conditions for which therapeutic strategies aim to alleviate their associated pain as well as to decrease their severity or prevent their occurrence (LeBon et al., 2009; Salerno et al., 2016; Shillingburg et al., 2017) Despite current strategies, treatment has remained a challenge, due to few available options, limited effects, and unwanted side effects. (LeBon et al., 2009; Salerno et al., 2016; Shillingburg et al., 2017). When compounded therapies are appropriate, compounding opportunities for intraoral pain disorders include topical options and tailored dosing of active ingredients covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Osteoarthritis symptoms are predominantly experienced as inflammatory pain, lending to a management approach that is governed mainly by pain relief and control, predominantly with oral and intra-articular therapies but for which are limited by their degree of efficacy and side effects (Conaghan et al., 2019). When compounded therapies are appropriate, compounding opportunities include topical options and tailored dosing of common active ingredients covering different mechanisms of action used to treat inflammatory pain from osteoarthritis. Explore efficacy, safety, and dosing evidence below:

Procedural pain can manifest as a chronic condition, with conventional analgesic options providing relief but with associated adverse effects (Fregoso et al., 2019). However, alternative therapies, including multimodal analgesia and anesthetic techniques, as well as early identification of perioperative, genetic, physiologic, and psychologic factors can help reduce side effects and chronic pain incidence (Fregoso et al., 2019). When compounded therapies are appropriate, compounding opportunities for procedural pain include topical options and tailored dosing of active ingredients covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Vulvodynia affects approximately 8–10% of women and is described as vulvar pain ( >3 months without identifiable cause), with associated factors such as musculoskeletal and neurological factors, comorbid pain syndromes (e.g. fibromyalgia), and psychosocial factors (Bergeron et al., 2020). Pharmacological intervention for pain management is the mainstay of treatment for this chronic pain condition, with a multimodal approach considered effective in patients with comorbid conditions (e.g. mood disorders, other pain disorders) (Bergeron et al., 2020). When compounded therapies are appropriate, compounding opportunities for vulvodynia include topical options and tailored dosing covering different mechanisms of action. Explore efficacy, safety, and dosing evidence below:

Sample Formulas^*.

Evidence-Based Medicine Starts Here.

Compounded Medication	Compounding Base	Clinical Reference(s)	Formula Reference
Diltiazem HCl 2%, Lidocaine HCl 5% Rectal Mucoadhesive Gel	NovaFilm™ Gel	Jonas et al., 2001; Kujur et al., 2020; Sugerman, 2014; Teimouri et al., 2020a; Teimouri et al., 2020b	F 008 265
Lidocaine 1.5%, Nifedipine 0.3% Rectal Ointment	AlpaWash^®	Perrotti et al., 2010	F 007 548
Nifedipine 32.5 mg Rectal Suppositories (7.0 mL)	SPG Supposi-Base™	Allen, 2017; ClinicalTrials.gov (2015); Teimouri et al., 2020; van Hoogdalem et al., 1991	F 005 869

* 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. Bases used in pain management depend on the desired route of administration or dosage form: creams or gels for topical and vaginal use; capsules, tablets, or liquids for oral administration; solutions for the oral activity; troches or rapid-dissolve tablets for buccal or sublingual administration; suppositories for rectal/vaginal application. 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 carrying capacity with consideration for the concentration or amount of active ingredient.

Base compatibility with multiple active ingredients in a single preparation.

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:

Ensom, MH & Decarie, D. (2016). Dexamethasone 1 mg/ml suspension prepared from crushed tablets: stability in glass and plastic bottles and plastic syringes. Can J Hosp Pharm. 69(1):49–51. View Study Report>

Medisca. (2021). Stability assessment of compounded preparations – Bracketed Diclofenac Sodium 1-15% in VersaPro™ Gel Base. View Study Report>

Medisca. (2021). Stability assessment of compounded preparations – Bracketed Diclofenac Sodium 1-15% in PLO Gel MediFlo™ 30. 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. Select a route of administration for noteworthy properties that may be considered for pain management:

Topical/Transdermal

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

Moisturizing properties. This may be desired for a patient with dry skin or mucosal membranes.

Carrying capacity. Selecting a base according to its compatibility with the concentration or amount of active ingredient is an important consideration, especially with high concentration active ingredients.

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

Oral

Solubility/absorption properties. Blended bases for capsules contain excipients that complement different solubility/absorption properties. These include hygroscopic, poorly soluble, and highly soluble actives.

Buccal/Sublingual

Mucoadhesive. This feature is sought after when considering a base for its application to mucosal areas such the oral cavity.

Melting property. Certain dosage forms require heating or melting the base during the compounding process. A base with a lower melting temperature may be required by certain active ingredients that are heat labile.

Dissolution/disintegration properties. These features are important when considering a base for its affect on the time to onset of action of the active ingredient.

Rectal/Vaginal

Mucoadhesive. This feature is sought after when considering a base for its application to mucosal areas such the vagina and rectum.

Moisturizing properties. This may be desired for a patient with dry skin or mucosal membranes.

Viscosity. A base with a mild to high viscosity may be preferred for these regions to minimize leakage and overall messy application.

Drug-release rate. This property is important to consider when selecting a suppository base for an active ingredient. For example, if requiring a slower release rate for a lipophilic active ingredient, an oily suppository base vs a water-soluble base would be the more desirable option.

Effect on pH. It is important that the properties of the base are suitable for the vaginal environment where vaginal pH is not affected.

Healing properties. This feature is important to consider to facilitate wound healing (e.g. for anal fissures) where the base can be easily removed to maintain wound cleanliness, but adherent enough to maintain a moist environment.

Industry-Leading Compounding Bases for Pain Management

	VersaPro™ Cream Base	Transdermal Pain Base	PLO Transdermal Cream	Penderm™ Cream Base
Description	White, shiny, medium viscosity, oil in water cream	Off-white, high viscosity cream	Off-white, lower viscosity cream	White, medium viscosity cream
Recommended Use	If permeation or stability data is preferred, if moisturizing effects are desired, or if application to mucous membranes is needed	If a base that is PLO-based without sticky effects is desired, if permeation/ stability data is preferred, or if compatibility with high concentration ingredients is required	If a cream that is PLO-based is preferred (note: this base is better suited to lower concentration of actives <10%)	If a versatile cream that is compatible with high concentration of actives is desired
HRIPT Tested	✓	x
PLO Based	x	✓	✓	x
Free of Parabens, Mineral Oil, & Fragrances	✓	x	Free of mineral oil & fragrances	Free of Parabens
Suitable for Application to Mucous Membranes	✓	x	x	x
Salt Tolerant	✓	✓	✓	✓
Excellent Permeation	✓	✓	✓	✓
Wide pH Stability	✓	✓	✓	✓
Other Features	Proven 24-hour moisturizer
Studies	Permeation study : Percutaneous absorption of progesterone in VersaPro™ Cream, PLO Transdermal cream, and Liposomal Base > Stability-indicating study: Benzocaine 20%, Lidocaine 6%, Tetracaine 4% > Stability-indicating study: Diclofenac Sodium 1%-15% (Bracketed) > Stability-indicating study: Ketamine 0.5%-10% (Bracketed) > Stability-indicating study: Ketoprofen 2.5%-30% (Bracketed) >	Permeation study: Percutaneous absorption of diclofenac in Transdermal Pain Base and Liposomal Cream Base >	Permeation study : Percutaneous absorption of progesterone in VersaPro™ Cream, PLO Transdermal cream, and Liposomal Base >

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/transdermal and vaginal/rectal routes of administration for pain management, 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 pain management - Dr. Miguel De La Garza and Dr. Ken Speidel - at LP3 Network's Pain Management Seminar event. Attend together with your compounding pharmacist and save. Improved patient care starts with collaborative efforts between providers and continued education.

Personalized Analgesic Therapy: Targeting Pain at its Source

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Also explore our library of on-demand programs on pain management that may interest you!

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