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20 Pharmaceutical Technology ® | BioPharm International ® Trends in Manufacturing May 2025 PharmTech.com COMPOUNDING beling "codeine" is not the same as labeling "codeine phosphate"). Non-salt drug labeling. The labeling of covalent compounded preparations is straightfor ward. Co- valent active moieties are of ten the drugs in com- pounded dosage forms. The stated amount of drug must clearly identif y the name and dr ug amount (e.g., Diazepam 10 mg tablets). Approved commer- cial product labeling containing the compounded drug may be checked to verify equivalence of active moiety and drug in labeling. Salt drugs labeling. FDA guidance documents illustrate labeling of dosage forms containing salt drugs. The following examples illustrate the com- pounding dilemma involving salt drugs—are salt dr ugs labeled according to their active moiet y or bulk drug? Figure 2 illustrates a salt drug label with active moiety as drug name. This label represents product in compliance with the drug salt policy (i.e., active moiet y is the focus of compounding and as- sociated calculations; ionic non-active counterions a re in seconda r y labeling). Labeling of t h is t y pe would have been approved after USP salt policy was implemented. Note active moiety on primary label and the drug (larger number) on side panel of label. Naming and labeling of salt drugs is applicable to compounded dosage forms. Policy-exception salt labeling. Figure 3 i l lus- trates a policy-exception salt drug label with drug not at ion on t he pr i ma r y label a nd ac t ive moiet y ca lculation in the side panel (i.e., opposite of Fig- ure 2). This label demonstrates labeling for a pre- 2013 approved sa lt d r ug produc t—t he ent i re sa lt dr ug amount (Olddr ug pa lmitate) is dosed as t he ac t ive moiet y per USP sa lt-g u id a nce except ion s. T h is approach is appl ied to compou nded dosage forms involving dr ugs identified as exceptions to the salt policy. Calculations hazards Several considerations are potential hazards to drug selection, calculations, and labeling in compounded dosage forms. Understanding drug chemistry is funda- mental. Misunderstanding of the USP salt policy caus- ing dosage errors and labeling errors is an obvious prob- lem. Labeling on approved commercial products may not be consistent with examples described previously. Drug chemistry. Compounding personnel involved with the selection of drugs for compounding must have a good understanding of basic drug chemistry; molecular masses, moles, structures, and associated topics are relevant in compounding calculations. Se- lection of a drug is critical; molecule physicochemical properties may be relevant to compounding (e.g., val- proic acid is an insoluble oil and divalproex sodium is a water-soluble solid). The choice of drug and eval- uation thereof must be based on technical judgment. Regulations addressing drugs in compounding are also noteworthy; FDA has cautioned regarding use of semaglutide (Ozempic), semaglutide sodium, and semaglutide acetate; the aforementioned salt forms are not FDA-approved (29,30). FDA has also reminded FIGURE . Salt drug dosage form label–active moiety drug name. Note active moiety on primary label; side panel provides bulk drug calculation. FIGURE . Policy-exception salt drug dosage form label–bulk drug name. Note bulk drug name on primary label; side panel provides active moiety calculation.