Compounding pharmacies operate in a complex regulatory environment where not all deficiencies carry equal consequences. Traditional checklist-based inspections are effective at verifying compliance with published standards, but they often fail to distinguish minor documentation lapses from conditions that pose significant risk to patients, staff, or the viability of the pharmacy itself. Risk-based auditing offers a more targeted, defensible approach, one that aligns inspection effort with the severity and likelihood of harm. This article explores how risk-based auditing principles can be applied to 503A pharmacy accreditation, and how hybrid models can deliver both comprehensive oversight and meaningful risk reduction.

Sodium Carboxymethyl Cellulose (NaCMC) is frequently employed in pharmaceutical formulation. Nevertheless, there are potential interactions between NaCMC and specific drugs, which may have an impact on the stability or bioavailability of those drugs.The purpose is to study the effect of drugs with different charges, anionic Sodium Carboxymethyl Cellulose (NaCMC), excipients, and other parameters on shape, size, and drug release from controlled release matrices of three different drugs and the kinetics of drug release were investigated. Three models of drug matrices (Flurbiprofen, naproxen sodium, and propranolol hydrochloride) were prepared using the direct compression technique with different ratios of sodium carboxymethyl cellulose, other excipients, and surfactants of various solubility and charges. These were used to compare drug release from the matrices in simulated intestinal fluid pH = 7.4 and simulated gastric fluid pH = 1.2. The size and shape changes of the matrices were investigated when these tablets were placed in simulated gastric fluid and simulated intestinal fluid. The mechanisms of drug release were analyzed using different models and equations. Sodium Carboxymethyl Cellulose (NaCMC) had the most significant effect on controlling drug release, swelling rate, size, and shapes of the matrices of the three drugs, regardless of their solubility. The pH of the dissolution medium, surfactants and other excipients, charge, and solubility of the drug also influenced drug release, tablet size, and shape of the different formulations. The swelling rate of the different matrices was constrained only by NaCMC. The ratio of anionic NaCMC primarily controlled the release rate of drugs. The shape and size of the matrices, according to the solubility and charge of these drugs. Other excipients, such as surfactants, lactose, and magnesium stearate, affected the release rate of the drugs, shape and size of the matrices but did not influence their swelling rate.

The increasing prevalence of skin conditions like acne, rosacea, and hyperpigmentation highlights the need for personalized dermatological treatments, with compounded formulations providing tailored solutions by combining multiple active pharmaceutical ingredients (APIs). This study evaluates the compatibility and stability of various formulations compounded in Cleoderm™, a cream base designed for acne-prone, affected, or sensitive skin. The tested formulations included: adapalene 0.1% or 0.3% and benzoyl peroxide 1.0% or 5.0%; hydroquinone 4.0%, hydrocortisone 1.0%, and tretinoin 0.0125%; azelaic acid 15.0% or 20.0% and niacinamide 4.0%; niacinamide 4.0% and tretinoin 0.025%; and clindamycin hydrochloride 3.0%. Each formulation underwent high-performance liquid chromatography (HPLC) and microbiological assessments over a 180-day period to determine stability and beyond-use dates (BUDs). Both formulations containing adapalene and benzoyl peroxide demonstrated excellent stability, with an assigned BUD of 180 days. Formulations of azelaic acid combined with niacinamide and niacinamide with tretinoin also showed sustained stability with BUDs of 180 days. In contrast, the formulation containing hydroquinone, hydrocortisone, and tretinoin had a BUD of 14 days. Clindamycin hydrochloride displayed a similar pattern, with stability maintained for 14 days. Microbiological evaluations confirmed the antimicrobial efficacy of all formulations, meeting United States Pharmacopeia (USP) requirements for antimicrobial effectiveness throughout their respective BUDs. The findings underscore the importance of evaluating the stability and compatibility of compounded formulations to ensure their safety and efficacy. This study supports the use of Cleoderm™ as a versatile and reliable base for personalized dermatological treatments, providing evidence-based BUDs to guide clinical practice.

SyrSpend® SF PH4 is a preservative-free oral suspending vehicle widely used in extemporaneous compounding. While its chemical stability has been previously demonstrated for various active pharmaceutical ingredients (APIs), microbiological stability data remain limited. This study aimed to evaluate the microbiological stability of oral suspensions containing dapsone, griseofulvin, levofloxacin, terbinafine, indometacin, naproxen, and paracetamol in SyrSpend® SF PH4, under both room temperature and refrigerated conditions. Formulations were assessed over 90 days for physical appearance and pH. Antimicrobial effectiveness testing (AET) was conducted according to USP <51> against Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and Aspergillus brasiliensis. All formulations maintained stable pH and appearance throughout the study. AET results showed a reduction of microbial counts to below detectable levels (log 1.0) by day 14, sustained through day 28, meeting USP <51> acceptance criteria. SyrSpend® SF PH4 effectively preserved the microbiological integrity of all tested formulations without added preservatives. These findings complement existing chemical stability data and support the use of SyrSpend® SF PH4 as a safe and effective vehicle for extemporaneous oral suspensions, particularly in populations requiring preservative-free formulations.

Water is the most abundant substance on earth, covering about 70% of the earth's surface. Life is dependent upon water and the water cycles involved. In pharmaceutical compounding, water is the most widely used excipient employed as a solubilizing agent and as a vehicle; it is also used medicinally. With the variety in dosage forms, there are different types of waters that are used, some with specific uses and some more general. For the different types or categories of water, there are different methods of preparation, different characteristics, and different properties that can be used as an advantage in compounding. This article describes the different categories of waters, their use, preparation, characteristics, and water chemistry in general.

Healthcare providers often need to explore alternative options for patients who are unable to swallow whole tablets or capsules. Many newly approved immediate-release (IR) solid oral drugs carry a general "do-not-crush" warning or similar statements in their labeling without any explanations. A 2021 publication by Uttaro et al. presented a crushability analysis strategy for risk assessment and demonstrated its utility for some uncertain IR drugs on the ISMP do-not-crush list. This article provides an update on the topic and performs the crushability analysis of newly FDA-approved drugs. The novel drug approvals from 2020-22 were obtained from the FDA website. The IR oral tablets and capsules were extracted from the lists and subjected to crushability analysis. The scope of crushing activity was defined as crushing the tablets or capsule contents using a mortar and pestle, followed by suspending the powder in plain water at room temperature and administering the dose within 2 hours. The crushability analysis employed a checklist of questions regarding special dosage form design, hazardous drug status, stability & pharmacokinetics (PK), unofficial data from manufacturers, and availability of alternative dosage forms. The FDA-approved product labels were used as the main references for the analysis. NIOSH publications, FDA Orange Book, patents, and scientific literature were used for selected drugs. From 2020 to 2022, 52 novel drug approvals were identified as IR oral tablets and capsules. Among them, 2 products were discontinued, and 10 already included specific manipulation instructions on their labels. The remaining 40 products had either a general "do-not-crush" statement or no information regarding crushability on the labels. The crushability analysis of these 40 products revealed that 23 products exhibited a low risk for crushing. However, the remaining 17 products were not suitable for crushing due to mostly stability/PK concerns. Four manufacturers had unofficial data related to crushing or mixing with liquids/soft foods, and none of the products had alternative oral liquid dosage forms. The crushability analysis strategy was updated and applied to 40 IR oral tablets and capsules approved by FDA during 2020-22. The summary table and highlighted examples serve as a practical resource for pharmacists and other healthcare providers to make informed decisions regarding dosage form manipulation to facilitate dose administration in patients with difficulty swallowing solids.

These recommended tips can be set up as free-of-charge, attractive pamphlets, which can either be given to the veterinary patient's owner when medications are supplied or made available as a display.

The release of United States Pharmacopeia Chapter <800> and the revisions to United States Pharmacopeia Chapter <795> (official November 1, 2023) indicates a changing regulatory climate and a trend towards increasingly high standards for the extension of beyond-use dates beyond the default recommended by the guidelines. Given the increased scrutiny and the additional requirements for establishing extended beyond-use dates, additional testing is required to help pharmacies provide the best formulations with scientifically robust data to support an extended beyond-use date for patient convenience. The objective of this study was to demonstrate the suitability of two vehicles, Phytobase and HRT Heavy, for compounded hormone therapy by evaluating the stability and antimicrobial effectiveness of the vehicles with common combinations of hormones.

The Alliance for Pharmacy Compounding recently released four resource documents aimed at shaping compounding best practices and regulatory compliance.