Call MEDISCA now at 1-800-932-10391-800-665-6334
  • 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
  • BUDs 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 BUD 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
  • BUD 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, vacations)
    • 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
Red Boat

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 also 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 have invested in over 20 new stability-indicating studies


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 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
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Oral
Topical


= Controlled substance in US and Canada


APIsBASESBUD
FORMULAS
Acetazolamide 25mg/mL ORAL MIX 90 days at 5oC and 25oC F 006 865
Acetazolamide 25mg/mL ORAL MIX SF 90 days at 5oC and 25oC F 006 867
Acetazolamide 25mg/mL * ORAL MIX 90 days at 5oC and 25oC F 006 866
Acetazolamide 25mg/mL * ORAL MIX SF 90 days at 5oC and 25oC F 006 868
Allopurinol 20mg/mL * ORAL MIX 90 days at 5oC and 25oC F 007 401v2
Allopurinol 20mg/mL* ORAL MIX SF 90 days at 5oC and 25oC 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 5oC and 60 days at 25oC F 006 037v3
Amlodipine Besylate 1mg/mL ORAL MIX 90 days at 5oC and 60 days at 25oC F 006 038v4
Azathioprine 50mg/mL ORAL MIX 90 days at 4oC and 25oC F 006 377v2
Azathioprine 50mg/mL ORAL MIX SF 90 days at 4oC and 25oC F 006 376
Azathioprine 50mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 375
Azathioprine 50mg/mL * ORAL MIX SF 90 days at 4oC and 77 days at 25oC 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 4oC and 23oC F 006 028v4
Clonazepam 0.1mg/mL * ORAL MIX 90 days at 4oC and 25oC F 007 549v2
Clonazepam 0.1mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 007 550
Clonidine Hydrochloride 0.01mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 029v2
Clonidine Hydrochloride 0.01mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 030v2
Clozapine 25mg/mL-50mg/mL (Bracketed) * 50:50 MCG 1%/Oral Syrup 120 days at 4oC and 25oC F 008 770
Dapsone 2mg/mL * ORAL MIX 90 days at 5oC F 007 164
Dapsone 2mg/mL * ORAL MIX SF 90 days at 5oC and 25oC F 007 165
Dexamethasone 1mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 624v2
Dexamethasone 1mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 625v3
Dexamethasone Phosphate 1mg/mL * ORAL MIX 90 days at 4oC and 25oC F 005 998v2
Dexamethasone Phosphate 1mg/mL * ORAL MIX SF 90 days at 4oC and 25oC 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 120 days at RT and ongoing 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** 120 days at RT and ongoing F 008 949
Diazoxide 10mg/mL ORAL MIX 90 days at 4oC and 25oC F 006 372
Diazoxide 10mg/mL ORAL MIX SF 90 days at 4oC and 25oC F 006 371
Diazoxide 10mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 369
Diazoxide 10mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 370
Diclofenac Sodium 1%-15% (Bracketed) PLO GEL MEDIFLO 30 (Compound Kit) 90 days at RT and ongoing F 008 947
Diclofenac Sodium 1%-15% (Bracketed) VERSAPRO CREAM BASE** 120 days at RT and ongoing F 008 945
Diclofenac Sodium 1%-15% (Bracketed) VERSAPRO GEL BASE 120 days at RT and ongoing F 008 946
Dipyridamole 10mg/mL * ORAL MIX 90 days at 5oC and 25oC F 007 551v2
Dipyridamole 10mg/mL * ORAL MIX SF 90 days at 5oC and 25oC F 007 552v2
Domperidone 5mg/mL * ORAL MIX 75 days at 4oC and 25oC F 006 041v5
Enalapril Maleate 1 mg/mL ORAL MIX 90 days at 5oC and 25oC F 006 034v3
Enalapril Maleate 1 mg/mL * ORAL MIX 90 days at 5oC and 25oC 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
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 25oC F 006 620v2
Gabapentin 100mg/mL ORAL MIX SF 90 days at 25oC F 006 621
Gabapentin 100mg/mL * ORAL MIX 90 days at 25oC F 006 622
Gabapentin 100mg/mL * ORAL MIX SF 90 days at 25oC F 006 623
Hydrocortisone 2mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 373
Hydroquione 2%-10% (Bracketed) HRT CREAM BASE 60 days at RT and ongoing F 008 950
Hydroxychloroquine Sulfate 25mg/mL * ORAL MIX 90 days at 4oC and 21oC F 006 870v3
Hydroxychloroquine Sulfate 25mg/mL * ORAL MIX SF 90 days at 4oC and 21oC F 006 871v3
Levetiracetam 50mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 379
Levetiracetam 50mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 378
Melatonin 2.0mg/mL ORAL MIX 90 days at 4 oC and 25oC F 006 112
Melatonin 2.0mg/mL ORAL MIX SF 90 days at 4 oC and 25oC F 006 128
Melatonin 2.0mg/mL * ORAL MIX 90 days at 4 oC and 25oC F 006 126
Melatonin 2.0mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 127
Metronidazole 50mg/mL ORAL MIX 90 days at 4 oC and 25oC F 006 998
Metronidazole 50mg/mL ORAL MIX SF 90 days at 4 oC and 25oC F 007 000
Metronidazole 50mg/mL * ORAL MIX 90 days at 4 oC and 25oC F 006 997
Metronidazole 50mg/mL * ORAL MIX SF 90 days at 4 oC and 25oC 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 4oC and 23oC F 006 176v2
Naproxen 25mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 429
Naproxen 25mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 430
Nitrazepam 1mg/mL * ORAL MIX 90 days at 4oC and 23oC F 007 435v3
Nitrazepam 1mg/mL * ORAL MIX SF 90 days at 4oC and 23oC F 007 436v3
Omeprazole 10 mg/mL (Bracketed) ORAL MIX ALKA, SF (Dry) Cherry Flavored 70 days at 4oC F 007 531v2
Omeprazole 2 mg/mL (Bracketed) ORAL MIX ALKA, SF (Dry) Cherry Flavored 70 days at 4oC F 007 304v2
Omeprazole 5 mg/mL (Bracketed) ORAL MIX ALKA, SF (Dry) Cherry Flavored 70 days at 4oC F 007 533v2
Piroxicam 10mg/mL ORAL SUSPEND 90 days at 4oC and 23oC F 007 992
Piroxicam 10mg/mL ORAL SUSPEND 90 days at 4oC and 23oC F 008 000
Prednisone 5mg/mL ORAL MIX 90 days at 5 oC and 25oC F 006 036v3
Prednisone 5mg/mL * ORAL MIX 90 days at 5oC and 25oC 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 4oC and 25oC F 006 031v2
Pyridoxine Hydrochloride 25mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 032v2
Ribloflavin 50mg/mL Oral Mix 90 days at 4oC and 25oC F 008 214
Ribloflavin 50mg/mL Oral Mix SF 90 days at 4oC and 25oC F 008 215
Sulfamethoxazole/Trimethoprim 40/8 mg/mL ORAL MIX 90 days at 5oC and 25oC F 007 892v3
Sulfamethoxazole/Trimethoprim 40/8 mg/mL ORAL MIX SF 90 days at 5oC and 25oC F 007 893v3
Tacrolimus 0.5mg/mL ORAL MIX 90 days at 5oC and 25oC F 006 040v4
Tacrolimus 0.5mg/mL * ORAL MIX 90 days at 5oC and 25oC F 006 039v2
Topiramate 5-40 mg/mL (Bracketed) * ORAL MIX 90 days at 25oC F 008 427
Topiramate 5-40mg/mL (Bracketed) ORAL MIX 90 days at 25oC F 008 426
Trimethoprim 10mg/mL * ORAL MIX 90 days at 4oC and 25oC F 006 658v2
Trimethoprim 10mg/mL * ORAL MIX SF 90 days at 4oC and 25oC F 006 657v2
Vancomycin 50mg/mL * ORAL SYRUP 90 days at 4oC F 007 084v2


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

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.
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What you don't know,
can hurt you...

YOUR SCORE:

Time to ramp up your BUD knowledge

1/7. What is best practice for extending BUD beyond USP guidelines? (select all that apply)



2/7. What are the key features of a stability indicating study? (Select all that apply)




3/7. How does a stability-indicating, extended BUD study benefit me as a pharmacist? (Select all that apply)




4/7. What is missing from a potency-only study?




5/7. What are the critical variables to be able to apply an extended BUD? (select all that apply)





6/7. If I compound a particular API in multiple strengths, do I need to perform a stability indicating study for each strength in order to apply an extended BUD? (select all that apply)


7/7. What is the difference between an expiration date and a BUD? Which of the following statements regarding expiration dates and BUDs are correct? (select all that apply)




Extending a BUD Beyond USP Guidelines

Important Features of a Stability Indicating Study

How does a BUD study benefit me as a pharmacist?

The Issue With Potency-Only Studies

Applying an Extended BUD

Compounding an API in multiple strengths

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VERSAPRO™ ANHYDROUS BASE
HRT CREAM BASE (For Women)
VERSAPRO™ CREAM BASE
VERSAPRO™ GEL BASE
ORAL MIX (Flavoured Suspending Vehicle)
ORAL MIX, SF (Sugar-Free Flavoured Suspending Vehicle)
ORAL SYRUP (Flavored Syrup Vehicle)
ORAL SYRUP, SF (Sugar-Free Flavoured Syrup Vehicle)
ORAL SUSPEND (Suspending Vehicle)
X

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