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BUDs

What are BUDs (Beyond-Use Dates)?
Establish BUDs

How do you establish a BUD?
Importance of BUDs

Why are BUD studies important?
Extended BUDs

What is the advantage of having extended BUD?

The BUD is the date or time, after which a compounded preparation can no longer be used, administered or stored, and is determined from the date the preparation is compounded.

USP <795>, NAPRA and APF have set forth guidelines for establishing beyond-use-dating of compounded preparations
Compounders should take into consideration the properties of the API(s), any excipients, the type of dosage form as well as container closure and storage conditions
Establishing the BUD of a compounded preparation should be based on concrete scientific data
The correct way to obtain an evidence-based BUD is by conducting a stability-indicating study
In the absence of supporting stability data, pharmacists refer to USP, NAPRA or APF guidelines

BUD stability studies help to ensure the integrity of the compounded preparation is maintained using validated, stability-indicating methods
They diminish potential risks that can affect patients, such as degradation of the active which can affect potency as well as safety due the formation of by-products over time, which can potentially be dangerous to the user
A stability-indicating study determines whether a preparation is able to maintain its strength and properties throughout its period of preparation, storage and use and to protect itself from degradation over time
These studies also allow compounders to extend the dating of compounded preparations beyond the default guidelines
In compliance with PCAB requirements for extending BUDs

Benefit the patient by:
- Increasing the accessibility of medically necessary treatments (ex. patients living far from a pharmacy or on vacation)
- Reducing prescription renewal frequency and in turn reducing costs
- Offering more peace of mind in receiving a compounded preparation
Benefit the pharmacy by:
- Improving pharmacy workflow
- Reducing costs by reducing labor (due to improved workflow), compounding larger batches and saving on shipping
- Providing the opportunity to prepare stock solutions

BUDs are much larger than they seem:

Stability-Indicating Studies are the gold standard for BUDs.
Expand the questions to see the bigger picture.

What is a stability-indicating study?

A stability-indicating study consists of a validated, quantitative, analytical procedure used to detect how the stability of a drug changes over time.
Stability-indicating assays can use techniques such as HPLC, MS, LC-MS/MS
A stability study includes:
- Method development
- Method validation
- Forced degradation study

Forced-degradation

Exposing the compound to extreme conditions (heat/humidity/uv radiation/acids/bases)
Separating the drug from degradant
Determining quality and durability of a compounded preparation

How do you determine you have a good stability-indicating study?

Stability-indicating assays
Validated methods
Statistical analysis
Independent & objective results
Published and peer-reviewed (bonus!)
Bracketed (bonus!)

What is a bracketed study?

The study of two concentrations of a specific API or formulation in the same base, container closure system and under the same storage conditions
The only variable is the difference in concentration of the drug – all other factors remain consistent throughout both studies
Any concentration within the bracket can receive the extended BUD if all parameters are kept the same (eg., concentration of levigating agent, base, container closure, storage condition, etc.)

In keeping up with industry trends and the ever-changing regulatory landscape, we have reformulated:

HRT CREAM BASE (For Women)
Removed Parabens

VERSAPRO™ GEL BASE
Removed Methylisothiazolinone/ Methylchloroisothiazolinone

VERSAPRO™ CREAM BASE
Removed Methylisothiazolinone/ Methylchloroisothiazolinone

Quality + Quantity

We have invested in quality, and now we are committed to providing more studies this year:

In 2020, we invested in over 20 new stability-indicating studies

HRT

PAIN

DERM

MEDISCA & BUDs

We keep your patients' health and safety our first priority, by

Investing in best practices
Contracting 3rd party institutions to conduct our studies
Studying multiple batches for reproducibility
Publishing results in USP monographs and peer-reviewed journals
Setting and exceeding industry standards

Keeping pharmacists top of mind

We developed bracketed BUD studies to provide the best resources for your practice, giving you flexibility to use our extended BUDs for a wide range of concentrations.

Single API studies at both low and high concentrations, facilitating larger batches for improved workflow and efficiency
Various combinations with commonly used HRT actives for added confidence and assurance

On-demand Webinar

Non-Sterile BUDs
Preparing for What's Ahead

Full Recording and Q&A

Still unclear?

Request a FREE 15-minute information session with MEDISCA's Compounding Support Team

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Topical

The following extended beyond-use dates (BUDs) were determined from stability studies, conducted by third-party institutions in Australia, Canada, and the United States. These studies used validated, stability-indicating assays with forced degradation methods, across multiple batches.

= Controlled substance in US and Canada

= Study reports that are freely available for download with a Medisca Account. Study reports include detailed information on study design, method, stability results, and more. If the PDF icon is not present, the study report is pending release - in the interim, for more information, please contact you Medisca Account Executive.

APIs	BASE	Extended BUD Result	FORMULAS
Acetazolamide 25mg/mL	ORAL MIX	90 days at 5^oC and 25^oC	F 006 865
Acetazolamide 25mg/mL	ORAL MIX SF	90 days at 5^oC and 25^oC	F 006 867
Acetazolamide 25mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 006 866
Acetazolamide 25mg/mL *	ORAL MIX SF	90 days at 5^oC and 25^oC	F 006 868
Allopurinol 20mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 007 401v2
Allopurinol 20mg/mL*	ORAL MIX SF	90 days at 5^oC and 25^oC	F 007 402v2
Amitriptyline HCl 10%	PLO GEL MEDIFLO 30 (Pre-Mixed)	90 days	F 008 219
Amlodipine 1mg/mL *	ORAL MIX	90 days at 5^oC and 60 days at 25^oC	F 006 037v3
Amlodipine Besylate 1mg/mL	ORAL MIX	90 days at 5^oC and 60 days at 25^oC	F 006 038v4
Azathioprine 50mg/mL	ORAL MIX	90 days at 4^oC and 25^oC	F 006 377v2
Azathioprine 50mg/mL	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 376
Azathioprine 50mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 375
Azathioprine 50mg/mL *	ORAL MIX SF	90 days at 4^oC and 77 days at 25^oC	F 006 374v2
Baclofen 2%, Cyclobenzaprine HCl 2%, Diclofenac Na 3%, Lidocaine HCl 2%, Ketoprofen 10%	TRANSDERMAL PAIN BASE	60 days at RT	F 008 302
Clobazam 1mg/mL *	ORAL MIX	90 days at 4^oC and 23^oC	F 006 028v4
Clonazepam 0.1mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 007 549v2
Clonazepam 0.1mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 007 550
Clonidine Hydrochloride 0.01mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 029v2
Clonidine Hydrochloride 0.01mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 030v2
Clozapine 25mg/mL-50mg/mL (Bracketed) *	50:50 MCG 1%/Oral Syrup	120 days at 4^oC and 25^oC	F 008 770v3
Dapsone 2mg/mL *	ORAL MIX	90 days at 5^oC	F 007 164
Dapsone 2mg/mL *	ORAL MIX SF	90 days at 5^oC and 25^oC	F 007 165
Dexamethasone 1mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 624v2
Dexamethasone 1mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 625v3
Dexamethasone Phosphate 1mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 005 998v2
Dexamethasone Phosphate 1mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 005 999v2
DHEA 0.2%-4%, Estradiol 0.01%-0.2%, Estriol 0.04%-0.8%, Progesterone 1%-20%, Testosterone 0.025%-0.5% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 948
DHEA 0.2%-4%, Estradiol 0.01%-0.2%, Estriol 0.04%-0.8%, Progesterone 1%-20%, Testosterone 0.025%-0.5% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 949
Diazoxide 10mg/mL	ORAL MIX	90 days at 4^oC and 25^oC	F 006 372
Diazoxide 10mg/mL	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 371
Diazoxide 10mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 369
Diazoxide 10mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 370
Diclofenac Sodium 1%-15% (Bracketed)	PLO GEL MEDIFLO 30 (Compound Kit)	180 days at RT	F 008 947
Diclofenac Sodium 1%-15% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 945
Diclofenac Sodium 1%-15% (Bracketed)	VERSAPRO GEL BASE	180 days at RT	F 008 946
Dipyridamole 10mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 007 551v2
Dipyridamole 10mg/mL *	ORAL MIX SF	90 days at 5^oC and 25^oC	F 007 552v2
Enalapril Maleate 1 mg/mL	ORAL MIX	90 days at 5^oC and 25^oC	F 006 034v3
Enalapril Maleate 1 mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 006 033v4
Estradiol 0.01%-10% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 332
Estradiol 0.01%-10% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 342
Estradiol 0.025%-0.25%, Estriol 0.025%-0.25%, Testosterone 1%-10% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 990
Estradiol 0.025%-0.25%, Estriol 0.025%-0.25%, Testosterone 1%-10% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 991
Estradiol 0.025%-0.5%, Estriol 0.025%-0.5%, Progesterone 1%-20% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 994
Estradiol 0.025%-0.5%, Estriol 0.025%-0.5%, Progesterone 1%-20% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 995
Estradiol 0.025%-0.5%, Estriol 0.1%-2% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 992
Estradiol 0.025%-0.5%, Estriol 0.1%-2% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 993
Estriol 0.01%-10% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 331
Estriol 0.01%-10% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 341
Gabapentin 100mg/mL	ORAL MIX	90 days at 25^oC	F 006 620v2
Gabapentin 100mg/mL	ORAL MIX SF	90 days at 25^oC	F 006 621
Gabapentin 100mg/mL *	ORAL MIX	90 days at 25^oC	F 006 622
Gabapentin 100mg/mL *	ORAL MIX SF	90 days at 25^oC	F 006 623
Hydrocortisone 2mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 373
Hydroquione 2%-10% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 950
Hydroxychloroquine Sulfate 25mg/mL *	ORAL MIX	90 days at 4^oC and 21^oC	F 006 870v3
Hydroxychloroquine Sulfate 25mg/mL *	ORAL MIX SF	90 days at 4^oC and 21^oC	F 006 871v3
Levetiracetam 50mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 379
Levetiracetam 50mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 378
Melatonin 2.0mg/mL	ORAL MIX	90 days at 4 ^oC and 25^oC	F 006 112
Melatonin 2.0mg/mL	ORAL MIX SF	90 days at 4 ^oC and 25^oC	F 006 128
Melatonin 2.0mg/mL *	ORAL MIX	90 days at 4 ^oC and 25^oC	F 006 126
Melatonin 2.0mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 127
Metronidazole 50mg/mL	ORAL MIX	90 days at 4 ^oC and 25^oC	F 006 998
Metronidazole 50mg/mL	ORAL MIX SF	90 days at 4 ^oC and 25^oC	F 007 000
Metronidazole 50mg/mL *	ORAL MIX	90 days at 4 ^oC and 25^oC	F 006 997
Metronidazole 50mg/mL *	ORAL MIX SF	90 days at 4 ^oC and 25^oC	F 006 999
Minoxidil 2%-5.5% (Bracketed)	FOAMIL	180 days at RT	F 008 208
Minoxidil 6%-15% (Bracketed)	FOAMIL	180 days at RT	F 008 224
Nadolol 10mg/mL *	ORAL MIX	90 days at 4^oC and 23^oC	F 006 176v2
Naproxen 25mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 429
Naproxen 25mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 430
Nitrazepam 1mg/mL *	ORAL MIX	90 days at 4^oC and 23^oC	F 007 435v3
Nitrazepam 1mg/mL *	ORAL MIX SF	90 days at 4^oC and 23^oC	F 007 436v3
Piroxicam 10mg/mL	ORAL SUSPEND	90 days at 4^oC and 23^oC	F 007 992
Piroxicam 10mg/mL	ORAL SUSPEND	90 days at 4^oC and 23^oC	F 008 000
Prednisone 5mg/mL	ORAL MIX	90 days at 5 ^oC and 25^oC	F 006 036v3
Prednisone 5mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 006 035v2
Progesterone 1%-40% (Bracketed)	HRT CREAM BASE	180 days at RT	F 008 566
Progesterone 1%-40% (Bracketed)	VERSAPRO CREAM BASE**	180 days at RT	F 008 567
Pyridoxine Hydrochloride 25mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 031v2
Pyridoxine Hydrochloride 25mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 032v2
Riboflavin 50mg/mL	Oral Mix	90 days at 4^oC and 25^oC	F 008 214
Riboflavin 50mg/mL	Oral Mix SF	90 days at 4^oC and 25^oC	F 008 215
Sulfamethoxazole/Trimethoprim 40/8 mg/mL	ORAL MIX	90 days at 5^oC and 25^oC	F 007 892v3
Sulfamethoxazole/Trimethoprim 40/8 mg/mL	ORAL MIX SF	90 days at 5^oC and 25^oC	F 007 893v3
Tacrolimus 0.5mg/mL	ORAL MIX	90 days at 5^oC and 25^oC	F 006 040v4
Tacrolimus 0.5mg/mL *	ORAL MIX	90 days at 5^oC and 25^oC	F 006 039v2
Testosterone 0.02%-25% (Bracketed)	HRT CREAM BASE	150 days at RT and ongoing	F 009 189
Testosterone 0.02%-25% (Bracketed)	VERSAPRO CREAM BASE	90 days at RT and ongoing	F 009 190
Testosterone 0.02%-25% (Bracketed)	VERSAPRO GEL BASE	90 days at RT and ongoing	F 009 191
Testosterone 25%	HRT CREAM BASE	180 days at RT	F 009 076
Testosterone 25%	VERSAPRO CREAM BASE**	180 days at RT	F 009 077
Topiramate 5-40 mg/mL (Bracketed) *	ORAL MIX	90 days at 25^oC	F 008 427
Topiramate 5-40mg/mL (Bracketed)	ORAL MIX	90 days at 25^oC	F 008 426
Trimethoprim 10mg/mL *	ORAL MIX	90 days at 4^oC and 25^oC	F 006 658v2
Trimethoprim 10mg/mL *	ORAL MIX SF	90 days at 4^oC and 25^oC	F 006 657v2
Vancomycin 50mg/mL *	ORAL SYRUP	90 days at 4^oC	F 007 084v2

* Preparation compounded using commercial drug product (ex. tablet, capsule, sterile powder for injection)

** Please note all BUDs with VersaPro Cream (2529) were conducted with the newly reformulated base, free of MI/MCI. All lot numbers associated to the reformulated base can be found here. Any subsequent lot numbers to 175032 will also apply.

Verify if you have purchased the reformulated VersaPro Cream Base

175031
175032

DISCLAIMER: This data is provided for informational purposes only, representing the results of a study of the product stability with various active pharmaceutical ingredients. For further information on packaging, please refer to the actual formula. This document does not serve, and may not be construed, as a representation or guarantee of product performance. In all cases the practitioner is advised to consult recognized pharmaceutical compendia and other recognized sources for product formulation and other product characteristics, including stability. MEDISCA and its affiliates make no warranties or representations with regards to the functioning or appropriateness of this product in anycompounded formulation, the use of which is solely at the discretion and liability of the practitioner. It is the responsibility of the pharmacist or other appropriately state licensed professional to verify the accuracy and validity of the information contained herein, with regards to scheduling, federal and state/provincial laws allowing the use of the formulas, products and final compounds in the country of use.