Clinical Pharmacology 
Considerations for 
Peptide Drug Products  
 
Guidance for Industry 
 
 
 
 
DRAFT GUIDANCE 
 
  This guidance document is being distributed for comment purposes only. 
 
Comments and suggestions regarding this draft document should be submitted within 90 days of 
publication in the Federal Register of the notice announcing the availability of the draft 
guidance. Submit electronic comments to https://www.regulations.gov. Submit written 
comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD  20852. All comments should be identified with the 
docket number listed in the notice of availability that publishes in the Federal Register. 
 
For questions regarding this draft document, contact (CDER) Office of Clinical Pharmacology 
Guidance and Policy at CDER_OCP_GPT@fda.hhs.gov. 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
December 2023 
Clinical Pharmacology 
 
   
Clinical Pharmacology 
Considerations for 
Peptide Drug Products 
 
Guidance for Industry 
 
Additional copies are available from: 
Office of Communications, Division of Drug Information  
Center for Drug Evaluation and Research 
Food and Drug Administration 
10001 New Hampshire Ave., Hillandale Bldg., 4th Floor  
Silver Spring, MD 20993-0002  
Phone: 855-543-3784 or 301-796-3400; Fax: 301-431-6353 
Email: druginfo@fda.hhs.gov  
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs  
 
 
 
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER) 
 
December 2023 
Clinical Pharmacology 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
TABLE OF CONTENTS 
 
 
 
I.  INTRODUCTION............................................................................................................. 1 
II.  CLINICAL PHARMACOLOGY CONSIDERATIONS .............................................. 2 
A.  Considerations for Assessing Immunogenicity ............................................................................ 3 
B.  Characterizing the Impact of Hepatic Impairment .................................................................... 4 
C.  Considerations for Assessing Drug Interactions ......................................................................... 5 
D.  Characterizing QT Interval Prolongation ................................................................................... 7 
III.  LABELING CONSIDERATIONS .................................................................................. 7 
 
 
 
 
 
 
 
 
 
 
  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
1  Clinical Pharmacology Considerations for Peptide Drug Products 
2  Guidance for Industry1 
3   
4   
5  This draft guidance, when finalized, will represent the current thinking of the Food and Drug 
6  Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 
7  binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 
8  applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 
9  for this guidance as listed on the title page.   
10   
11   
12   
13   
14  I.  INTRODUCTION 
15   
16  This guidance provides recommendations to assist industry in the development of peptide drug 
17  products. Specifically, this guidance, when finalized, will describe the FDAs current thinking 
18  regarding the impact of clinical pharmacology considerations, including hepatic impairment, 
19  drug-drug interactions (DDIs), QTc prolongation risk, and immunogenicity risk on a peptide 
20  drug products pharmacokinetics (PK), safety, and efficacy. 
21   
22  This guidance specifically outlines clinical pharmacology considerations for development 
23  programs for proposed peptide drug products submitted in a new drug application (NDA) under 
24  section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and references other 
25  relevant guidances when appropriate. The term peptide, for purposes of this guidance, refers to 
26  any polymer composed of 40 or fewer amino acids.2  In general, if a peptide meets the definition 
27  of a drug and does not otherwise meet the statutory definition of a biological product3 or a 
28  device,4 it would be regulated as a drug under the FD&C Act and be subject to all the drug 
29  requirements under the FD&C Act and FDAs regulations, including the requirement that new 
30  drugs must be approved under section 505(c) of the FD&C Act before they can be marketed in 
31  interstate commerce.5 However, peptide drug products can have product characteristics that may 
32  be similar, in certain respects, to biological products, and as such, this guidance includes 
33  references to other FDA guidances on biological products that discuss scientific principles that 
34  could also be applicable to peptide drug products.  
 
1 This guidance has been prepared by the Office of Clinical Pharmacology in the Center for Drug Evaluation and 
Research at the Food and Drug Administration.  
 
2 See, e.g., FDA Final Rule Definition of the Term Biological Product (85 FR 10057 March 23, 2020). 
 
3 See section 351(i)(1) of the Public Health Service Act (42 U.S.C. 262(i)(1)); see also FDA Final Rule Definition 
of the Term Biological Product (85 FR 10057, February 21, 2020). 
 
4 See section 201(h) of the FD&C Act.  
 
5 This guidance does not to apply to considerations for development programs for proposed peptide drug products 
submitted in abbreviated new drug applications (ANDAs) under section 505(j) of the FD&C Act.   
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Draft  Not for Implementation 
35   
36  Peptides can be isolated from animal tissue, produced synthetically, or produced through 
37  recombinant expression, and often serve as signaling molecules for many physiological 
38  functions. Recent drug development efforts have focused on improving the absorption, 
39  distribution, metabolism, and excretion (ADME) properties of native peptides, such as increasing 
40  oral bioavailability, increasing half-life, decreasing general hydrophobicity, and increasing 
41  conformational flexibility to increase selectivity of the intended target. To obtain more favorable 
42  ADME characteristics in patients, peptide drug products under development have included 
43  certain alterations to the peptide structure and/or incorporated new formulation strategies (e.g., 
44  liposomes). These structural alterations can include cyclization, pseudo-peptide bonds, unnatural 
45  amino acids, and peptide conjugations (e.g., PEGylation). As such, peptide drug products can 
46  exhibit distinct combinations of characteristics of both small and large molecules regarding their 
47  chemistry, pharmacology, pharmacokinetic disposition, and pharmacodynamics (PD). Of note, 
48  this guidance does not focus on the development of any particular peptide drug product. Any 
49  questions about regulatory requirements for a particular peptide drug product should be 
50  addressed to the appropriate FDA review division.   
51   
52  In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
53  Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
54  as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
55  the word should in Agency guidances means that something is suggested or recommended, but 
56  not required. 
57   
58   
59  II.  CLINICAL PHARMACOLOGY CONSIDERATIONS 
60    
61  Given that peptide drug products can have product characteristics similar to both small-molecule 
62  drugs and biological products, evaluating the clinical pharmacology of peptide drug products 
63  often incorporates aspects of both drug product and biological product development programs, 
64  which are discussed in the sections below.6 
65   
66  However, there are some clinical pharmacology topics where FDA guidance already exists as it 
67  relates to the development of peptide drug products, such as: 
68   
69    Bioanalytical Approach:  All bioanalytical methods should be validated and reported as 
70  recommended in the FDA guidance entitled M10 Bioanalytical Method Validation and 
71  Study Sample Analysis (November 2022).7 
72   
 
6 This guidance pertains to whether a peptide drug product can be shown to be safe and effective for its intended use 
under section 505(d) of the FD&C Act and does not address the analyses or studies may be needed to support a 
therapeutic equivalence evaluation.  
 
7 We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 
 
  2  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
73    Radiolabeled Mass Balance Studies:  Unless clinical concerns suggest otherwise, human 
74  radiolabeled mass balance studies might not be recommended in certain circumstances, 
75  such as for drugs with known metabolism and elimination pathways based on basic 
76  pharmacology and nonclinical ADME information.8 
77   
78    Impaired Renal Function:  Studies to characterize the impact of renal impairment on the 
79  PK are recommended for therapeutic proteins and peptides with a molecular weight less 
80  than 69 kDa.9 
81   
82  A.  Considerations for Assessing Immunogenicity  
83   
84  1.  Performing the Immunogenicity Risk Assessment 
85   
86  Most peptide drug products have the potential for immunogenicity; as such, sponsors should 
87  generally assess the immunogenicity risk for all peptide drug products. Assessing the 
88  immunogenicity risk for peptide drug products is similar to therapeutic proteins and involves 
89  understanding certain product-specific factors (e.g., molecular size and structure), process-
90  specific factors (e.g., host cell proteins), subject-specific factors (e.g., disease state), and factors 
91  related to study design and product use (e.g., dosing regimen, route(s) of administration, and 
92  concomitant drugs). Factors related to immunogenicity risk of peptides are consistent with the 
93  scientific principles outlined in the FDA guidance for industry entitled Immunogenicity 
94  Assessment for Therapeutic Protein Products (August 2014). In general, peptide drug products 
95  that are less than eight amino acids are not expected to be immunogenic unless there is an 
96  immunogenicity risk due to product impurities or aggregates.  
97   
98  Sponsors are encouraged to discuss their assessment of their products immunogenicity risk (e.g., 
99  immunogenicity risk assessment) and how that risk will inform their evaluation of the anti-drug 
100  antibody (ADA) incidence, titers, and neutralizing activity and their impact on PK, PD, efficacy, 
101  and safety (e.g., clinical immunogenicity assessment) early in the development program with the 
102  Agency. 
103   
104  2.  Performing the Clinical Immunogenicity Assessment 
105   
106  A multitiered clinical immunogenicity assessment of a peptide drug product should be informed 
107  by the immunogenicity risk assessment and conducted in a manner consistent with the scientific 
108  principles described in the FDA guidances Immunogenicity Assessment for Therapeutic Protein 
109  Products (August 2014) and Immunogenicity Testing of Therapeutic Protein Products  
110  Developing and Validating Assays for Anti-Drug Antibody Detection (January 2019). For a 
111  peptide drug product with multiple domains, it might be appropriate to develop multiple assays 
 
8 For more information, see the draft FDA guidance for industry entitled Clinical Pharmacology Considerations for 
Human Radiolabeled Mass Balance Studies (May 2022). When final, this guidance will represent the Agencys 
current thinking on this topic. 
 
9 For more information, see the draft FDA guidance for industry entitled Pharmacokinetics in Patients with 
Impaired Renal Function  Study Design, Data Analysis, and Impact on Dosing (September 2020). When final, this 
guidance will represent the Agencys current thinking on this topic. 
  3  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
112  to measure the immune responses to the different domains. For a peptide product with sequence 
113  homology to an endogenous protein or peptide counterpart, it might also be appropriate to 
114  develop an assay to measure cross-reactivity of ADAs between the peptide drug product and 
115  endogenous counterpart. The need for and design of these assays should be informed by the 
116  immunogenicity risk and clinical concerns and should be discussed with the Agency. 
117   
118  3.  Conducting the Immunogenicity Clinical Impact Analysis 
119   
120  The clinical immunogenicity assessment should be designed to assess the clinical impact of 
121  ADAs on the peptide drug products PK, PD, efficacy, and safety. Specifically, both between-
122  subject (i.e., between subjects who test ADA positive and those who test ADA negative) and 
123  within-subject comparisons (i.e., before ADA positive and after ADA positive) should be 
124  assessed. For all individual subjects who test ADA positive, further evaluation on the effects of 
125  antibody titers and neutralizing antibodies on the peptide drug products PK, PD, efficacy, and 
126  safety should be assessed. 
127   
128  B.  Characterizing the Impact of Hepatic Impairment 
129    
130  Peptides are generally metabolized by endopeptidases, then further degraded to amino acids by 
131  exopeptidases. Due to the ubiquitous availability of proteases and peptidases throughout the 
132  body, proteolytic degradation of many peptides is rapid and not limited to organs typically 
133  associated with drug elimination, such as the liver. Therefore, hepatic metabolism rarely plays a 
134  significant role in the clearance of peptides. However, emerging evidence suggests that under 
135  certain circumstances it might be important to characterize the impact of hepatic impairment on 
136  the PK of some peptide drug products. Below are some characteristics that could result in a 
137  recommendation for a hepatic impairment assessment, such as conducting a dedicated hepatic 
138  impairment study: 
139   
140    Peptide drug products that are found to be substantially metabolized by liver enzymes (> 
141  20 percent of the systemically available drug) based on nonclinical models could have 
142  increased plasma exposure due to hepatic impairment. 
143   
144    Peptide drug products that result from certain modifications, such as cyclic peptides (e.g., 
145  cyclosporine and voclosporin), could render them susceptible to substantial metabolism 
146  by liver enzymes. 
147   
148    Peptide drug products that are substantially eliminated through biliary excretion (> 20 
149  percent of systemically available drug or active metabolite is eliminated unchanged in the 
150  bile), as determined by basic pharmacology and nonclinical ADME studies (i.e., bile-duct 
151  cannulated animal models), could have increased plasma exposure due to hepatic 
152  impairment, even if hepatic metabolism is not significant. 
153   
154    Peptide drug products that are conjugated with a lipid group (e.g., fatty acids or 
155  cholesterol) can be highly bound to serum albumin and lipids, and their elimination rate 
156  could be affected by the levels of serum albumin and lipids. Patients with chronic liver 
157  diseases, because of the potential for lower levels of serum albumin, could have an 
  4  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
158  increased elimination rate for certain types of peptide drug products (e.g., alkylated or 
159  acylated peptides). 
160   
161    Peptide drug products that are being developed for an indication with the liver as a target 
162  organ or in cases when the peptide drug product can be characterized as targeting the 
163  liver (e.g., GalNAc residues in the molecule) could be affected by hepatic impairment. As 
164  changes in liver function can result in pharmacodynamic changes that are independent of 
165  systemic pharmacokinetic changes, whenever appropriate and feasible, 
166  pharmacodynamic assessments should be included. 
167   
168    Peptide drug products that are subject to target-mediated drug disposition may have 
169  altered PK in patients with hepatic impairment as a result of changes in target expression. 
170  Whenever appropriate and feasible, pharmacodynamic assessments should be included. 
171   
172  Regardless of the above characteristics, there could be special considerations when the peptide 
173  drug product is being developed for a liver disease where hepatic impairment is common.10 For 
174  peptide drug products being developed for this population, the sponsor should assess the need for 
175  performing a hepatic impairment assessment and provide adequate justification for not 
176  performing an assessment based on the characterization of the peptide drug product.  
177   
178  Sponsors are encouraged to discuss the hepatic impairment assessment with the Agency early in 
179  development to determine the most appropriate approach. Recommendations describing the 
180  design of hepatic impairment assessments can be found in FDA guidances entitled 
181  Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and 
182  Impact on Dosing and Labeling (May 2003) and Population Pharmacokinetics (February 2022).  
183   
184  C.  Considerations for Assessing Drug Interactions 
185    
186  1.  Pharmacokinetic Interactions  
187    
188  a.  Peptide drug product as substrates for CYP enzymes and transporters 
189   
190  In general, peptide drug products are primarily metabolized by proteolytic or hydrolytic enzymes 
191  such as endopeptidases, aminopeptidases, and carboxypeptidases, or are chemically modified to 
192  resist degradation, and are not metabolized by cytochrome P450 (CYP) enzymes. Therefore, the 
193  disposition of peptide drug products is not anticipated to be affected by inhibitors or inducers of 
194  CYP enzymes. Similarly, modulation of efflux transporters, such as P-gp and BCRP, or hepatic 
195  uptake transporters such as OATP1B1 and OATP1B3, or renal uptake or efflux transporters, 
196  such as OAT1, OAT3, OCT2, MATE1, and MATE2/K are generally not anticipated to have a 
197  significant impact on the PK of peptide drug products. There are cases when peptide drug 
198  products can be substrates of certain peptide transporters or amino acid transporters and could be 
199  subject to drug interactions. 
 
10 A dedicated hepatic impairment study should be conducted for a drug candidate developed for nonalcoholic 
steatohepatitis to characterize the effects of hepatic impairment on the drugs PK. See the FDA draft guidance 
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment (December 2018). 
When final, this guidance will represent the Agencys current thinking on this topic. 
  5  Contains Nonbinding Recommendations 
Draft  Not for Implementation 
200   
201  However, there are structural modifications to peptide drug products, such as cyclic peptides 
202  (e.g., cyclosporine and voclosporin) that could render them susceptible to CYP enzyme-mediated 
203  metabolism and transporter-mediated disposition. In vitro experiments related to CYPs and 
204  transporters may be scientifically appropriate when hepatic and/or biliary excretion accounts for 
205  >20 percent of the overall elimination and/or the drugs target organ is the liver. For more 
206  information, see the FDA guidance entitled In Vitro Drug Interaction Studies  Cytochrome 
207  P450 Enzyme- and Transporter-Mediated Drug Interactions Guidance for Industry (January 
208  2020). Additionally, in vitro experiments to evaluate a drug as a substrate of renal transporters 
209  may be appropriate for drugs with renal active secretion that accounts for >25 percent of 
210  systemic clearance of the drug and/or a drug that has renal toxicity. Sponsors should provide 
211  their plans and rationale early in development to evaluate whether peptide drug products are 
212  substrates of CYP enzymes and drug transporters. 
213   
214  b.  Peptide drug products as inhibitors and inducers of CYP enzymes and 
215  transporters 
216   
217  In general, peptide drug products are not expected to significantly modulate CYP enzymes and 
218  drug transporters. However, there are structural modifications to peptide drug products (e.g., 
219  cyclosporine and voclosporin) that could lead to modulation of CYP enzymes and drug 
220  transporters. In addition, there are cases where peptides indirectly affect CYP enzymes or 
221  transporters. One example is somatostatin analogs (e.g., lanreotide and octreotide) that reduce or 
222  are suspected to reduce the clearance of co-administered drugs indirectly by modulating the 
223  expression of CYP enzymes. For each development program, sponsors should provide their plans 
224  to evaluate the drug interaction liability of peptide drug products, as recommended in the FDA 
225  guidance entitled In Vitro Drug Interaction Studies  Cytochrome P450 Enzyme- and 
226  Transporter-Mediated Drug Interactions Guidance for Industry (January 2020). Regarding the 
227  recommendations for clinical assessment of DDIs, refer to the FDA guidance entitled Clinical 
228  Drug Interaction Studies  Cytochrome P450 Enzyme- and Transporter-Mediated Drug 
229  Interactions Guidance for Industry (January 2020).  
230   
231  Additionally, certain peptide drug products could alter the PK of concomitant drugs as a result of 
232  their mechanism of action. For example, glucagon-like peptide-1 (GLP-1) receptor agonists (e.g., 
233  exenatide and liraglutide) could delay gastric emptying of co-administered oral drugs. Also, in 
234  situations where the mechanism of action of the peptide drug product could affect the PK of co-
235  administered products, the sponsor should evaluate the peptide drug product as a perpetrator. 
236   
237  2.  Pharmacodynamic Interactions 
238   
239  Peptide drug products can exhibit pharmacodynamic interactions with a concomitant drug when 
240  the pharmacological effect of one drug is altered by that of another drug (e.g., concomitant use of 
241  vasopressin with catecholamines can result in an additive effect on mean arterial pressure and 
242  other hemodynamic parameters). Sponsors are encouraged to consult with the FDA regarding 
243  assessment of pharmacodynamic drug interactions.  
244   
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Draft  Not for Implementation 
245  D.  Characterizing QT Interval Prolongation 
246   
247  Peptides comprised of only naturally occurring amino acids have a low likelihood of direct ion 
248  channel interactions, and a thorough QT study is generally not scientifically warranted, unless 
249  the potential for proarrhythmic risk is suggested by mechanistic considerations or data from 
250  clinical or nonclinical studies.    
251   
252  When indicated, an assessment of QTc prolongation risk and a proposed QTc assessment plan 
253  should be submitted as described in the FDA guidances entitled E14 Clinical Evaluation of 
254  QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs 
255  (October 2012), the E14 Clinical Evaluation of QT/QTc Interval Prolongation and 
256  Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) (June 
257  2017), and E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation 
258  and Proarrhythmic Potential--Questions and Answers (August 2022). All proposals in the QTc 
259  assessment plan should contain a rationale and be discussed with the Agency. The timing and 
260  extent of the clinical QTc assessment depend upon the overall risk/benefit profile of the peptide 
261  drug product. 
262   
263   
264  III.  LABELING CONSIDERATIONS 
265   
266  For all prescription drug products, labeling must contain a summary of the essential scientific 
267  information needed for the safe and effective use of the product,11 and the labeling must be 
268  informative and accurate and neither promotional in tone nor false or misleading in any 
269  particular.12 
270   
271  The Prescribing Information must include information about the PK and PD of the peptide drug 
272  product to inform its safe and effective use by the health care provider.13,14 The labeling for 
273  peptide drug products  which are primarily metabolized by proteolytic or hydrolytic enzymes  
274  should include the following (or similar) statement under the Metabolism subheading under the 
275  Elimination heading in the Pharmacokinetics subsection of the CLINICAL PHARMACOLOGY 
276  section: 
277   
278  [Insert Drug Name] is expected to be metabolized into small peptides by catabolic pathways. 
279   
280  It is not necessary to include a statement in the CLINICAL PHARMACOLOGY section that 
281  peptide drug products do not have a clinically significant drug interaction with CYP inhibitors or 
282  CYP inducers because the catabolic metabolism of peptides is expected to be understood by 
 
11 21 CFR 201.56(a)(1). 
 
12 21 CFR 201.56(a)(2).  
 
13 See 21 CFR 201.57(c)(13). 
 
14 For more information, see the FDA guidance for industry entitled Clinical Pharmacology Section of Labeling for 
Human Prescription Drug and Biological Products  Content and Format (December 2016). 
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Draft  Not for Implementation 
283  healthcare providers; therefore, such information is not needed for the safe and effective use of 
284  the drug product.15 
285   
286  Given the potential for immunogenicity generally associated with peptide drug product 
287  administration, the labeling for such products should include immunogenicity information, 
288  consistent with the principles proposed in FDAs draft guidance Immunogenicity Information in 
289  Human Prescription Therapeutic Protein and Select Drug Product Labeling  Content and 
290  Format (February 2022).16 In general, the labeling for peptide drug products that are less than 
291  eight amino acids that are without concerns for impurities and/or aggregates do not need to 
292  include immunogenicity information because an immunogenicity assessment would likely not be 
293  relevant to the assessment of a drugs safety and effectiveness.17  
294    
295  The recommendations in other Prescribing Information guidances for drug products generally 
296  apply to peptide drug products and the principles from other Prescribing Information guidances 
297  for biological products may also be relevant.18,19,20,21 For additional human prescription drug 
298  labeling guidance documents, see the FDAs Labeling Resources for Human Prescription Drugs 
299  website.22  
 
15 21 CFR 201.56(a)(1).  
 
16 For proposed recommendations on how to incorporate immunogenicity information into the labeling of peptide 
drug products, see the FDA draft guidance for industry entitled Immunogenicity Information in Human Prescription 
Therapeutic Protein and Select Drug Product Labeling  Content and Format (February 2022). When final, this 
guidance will represent the FDAs current thinking on this topic. 
 
17 See 21 CFR 201.56(a).  
 
18 For more information, see the draft FDA guidance for industry entitled Dosage and Administration Section of 
Labeling for Human Prescription Drug and Biological Products  Content and Format (January 2023). When 
final, this guidance will represent the Agencys current thinking on this topic. 
 
19 For more information, see the FDA guidance for industry entitled Clinical Pharmacology Section of Labeling for 
Human Prescription Drug and Biological Products  Content and Format (December 2016). 
 
20 For more information, see the FDA guidance for industry entitled Warnings and Precautions, Contraindications, 
and Boxed Warning Sections of Labeling for Prescription Drug and Biological Products  Content and Format 
(October 2011). 
 
21  For more information, see the FDA guidance for industry entitled Patient Counseling Information Section of 
Labeling for Human Prescription Drug and Biological Products  Content and Format (December 2014). 
 
22 https://www.fda.gov/drugs/laws-acts-and-rules/prescription-drug-labeling-resources. Accessed August 2023. 
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