PRASTERONE SULFATE

First approved in 2014

Details

Stereochemistry	ABSOLUTE
Molecular Formula	C19H28O5S
Molecular Weight	368.488
Optical Activity	UNSPECIFIED
Defined Stereocenters	6 / 6
E/Z Centers	0
Charge	0

SHOW SMILES / InChI

Structure Search

SMILES

[H][C@@]12CCC(=O)[C@@]1(C)CC[C@@]3([H])[C@@]2([H])CC=C4C[C@H](CC[C@]34C)OS(O)(=O)=O

InChI

InChIKey=CZWCKYRVOZZJNM-USOAJAOKSA-N

InChI=1S/C19H28O5S/c1-18-9-7-13(24-25(21,22)23)11-12(18)3-4-14-15-5-6-17(20)19(15,2)10-8-16(14)18/h3,13-16H,4-11H2,1-2H3,(H,21,22,23)/t13-,14-,15-,16-,18-,19-/m0/s1

HIDE SMILES / InChI

Molecular Formula	C19H28O5S
Molecular Weight	368.488
Charge	0
Count

Stereochemistry	ABSOLUTE
Additional Stereochemistry	No
Defined Stereocenters	6 / 6
E/Z Centers	0
Optical Activity	UNSPECIFIED

Description
Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf
Curator's Comment: description was created based on several sources, including https://www.ncbi.nlm.nih.gov/mesh/68003687 | http://www.hmdb.ca/metabolites/HMDB00077

Dehydroepiandrosterone (INTRAROSA™, prasterone) is a major C19 steroid produced from cholesterol by the adrenal cortex. It is also produced in small quantities in the testis and the ovary. Dehydroepiandrosterone (INTRAROSA, prasterone) is structurally similar to, and is a precursor of, androstenedione, testosterone, estradiol, estrone and estrogen. It indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The mechanism of action of dehydroepiandrosterone (INTRAROSA, prasterone) in postmenopausal women with vulvar and vaginal atrophy is not fully established.

CNS Activity

Originator

Approval Year

Targets

Primary Target	Pharmacology	Potency
Estrogen receptor beta 110 Target ID: CHEMBL242 Sources: https://www.ncbi.nlm.nih.gov/pubmed/15994348	Agonist 2662	514.55 nM [Ki]
Estrogen receptor alpha 127 Target ID: CHEMBL206 Sources: https://www.ncbi.nlm.nih.gov/pubmed/15994348	Partial Agonist 288	1053.17 nM [Ki]
Androgen Receptor 167 Target ID: CHEMBL1871 Sources: https://www.ncbi.nlm.nih.gov/pubmed/15994348	Antagonist 2760	1177.02 nM [Ki]

Conditions

Condition	Modality	Targets	Highest Phase	Product
Dyspareunia 7 Sources: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf	Primary		Approved 8360	INTRAROSA Approved Use INTRAROSA™ is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Launch Date 1.47925434E12

C_max

Value	Dose	Co-administered	Analyte	Population
36.7 nM EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/10372727	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:		PRASTERONE serum	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

AUC

Value	Dose	Co-administered	Analyte	Population
176.1 nM × h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/10372727	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:		PRASTERONE serum	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

T_1/2

Value	Dose	Co-administered	Analyte	Population
5.35 h EXPERIMENT https://www.ncbi.nlm.nih.gov/pubmed/10372727	50 mg single, oral dose: 50 mg route of administration: Oral experiment type: SINGLE co-administered:		PRASTERONE serum	Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED

Doses

Dose	Population	Adverse events
1600 mg 1 times / day multiple, oral Highest studied dose Dose: 1600 mg, 1 times / day Route: oral Route: multiple Dose: 1600 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/2961787	healthy, 22-25 years n = 5 Health Status: healthy Age Group: 22-25 years Sex: M Population Size: 5 Sources: https://pubmed.ncbi.nlm.nih.gov/2961787	Sources: https://pubmed.ncbi.nlm.nih.gov/2961787
400 mg 1 times / day multiple, oral Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: https://pubmed.ncbi.nlm.nih.gov/16784956	unhealthy, 44.9 years n = 29 Health Status: unhealthy Condition: HIV infection Age Group: 44.9 years Sex: M Population Size: 29 Sources: https://pubmed.ncbi.nlm.nih.gov/16784956	Sources: https://pubmed.ncbi.nlm.nih.gov/16784956

Overview

CYP3A4	CYP2C9	CYP2D6	hERG
inhibitor 1579	inhibitor 1752	inhibitor 1837

OverviewOther

Other Inhibitor	Other Substrate	Other Inducer
CYP1A2 1509 CYP2A6 704 CYP2B6 799 CYP2C8 901 CYP2C19 1463 CYP2E1 876	17-beta-HSD1 6 5-alpha-reductase 1 6 CYP19A1 23 UGT 187 sulfotransferases 36 17-beta-HSD3 6 17-beta-HSD5 6 17-beta-HSD2 10 17-beta-HSD13 6 5-alpha-reductase 2 6 3-beta-HSD1 6 3-alpha-HSD1 6 3-alpha-HSD3 10 UGT2B28 63 UGT2B15 203 UGT2B17 213 UGT1A1 418

Drug as perpetrator

Target	Modality	Activity
CYP1A2 1673	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2A6 736	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2B6 985	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2C19 1537	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2C8 955	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2C9 1803	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2D6 1875	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP2E1 964	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no
CYP3A4 1909	inhibitor 3240 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	no

Drug as victim

Target	Modality	Activity
17-beta-HSD1 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
17-beta-HSD13 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
17-beta-HSD2 10	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
17-beta-HSD3 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
17-beta-HSD5 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
3-alpha-HSD1 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
3-alpha-HSD3 10	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
3-beta-HSD1 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
5-alpha-reductase 1 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=8 Page: 8.0	yes
5-alpha-reductase 2 6	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=8 Page: 8.0	yes
CYP19A1 23	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=4 Page: 4.0	yes
UGT 187	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	yes
UGT1A1 418	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
UGT2B15 203	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
UGT2B17 213	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
UGT2B28 63	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000PharmR.pdf#page=8 Page: 8.0	yes
sulfotransferases 36	substrate 3326 Sources: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208470Orig1s000ClinPharmR.pdf#page=9 Page: 9.0	yes

Sourcing

Vendor/Aggregator	ID	URL
AEchem Scientific Corp., USA	AE1-000705	http://www.aechemsc.com/info_products/AE1-000705.php
AHH Chemical co.,ltd	MT-00368	http://www.ahhchemical.com/product/MT-00368.html
AHH Chemical co.,ltd	MT-07566	http://www.ahhchemical.com/product/MT-07566.html
AK Scientific, Inc. (AKSCI)	70793	http://www.aksci.com/item_detail.php?cat=70793
AK Scientific, Inc. (AKSCI)	J10065	http://www.aksci.com/item_detail.php?cat=J10065
Aaron Chemicals	AR0039QK	http://www.aaronchem.com/53-43-0
AbMole Bioscience	M9061	http://www.abmole.com/products/dehydroepiandrosterone.html
Acadechem	ACDS-064086	http://www.acadechemical.com/product/138785
Achemo Scientific Limited	AC-15211	http://www.achemo.com/product_view.asp?ID=5101
Achemtek	0104-014342	http://www.achemtek.com/53-43-0
Acorn PharmaTech	ACN-036240	http://www.acornpharmatech.com/
Acros Organics	AC154980025	https://www.fishersci.com/shop/products/dehydroisoandrosterone-99-acros-organics-1/AC154980025
Acros Organics	AC154980100	https://www.fishersci.com/shop/products/dehydroisoandrosterone-99-acros-organics-1/AC154980100
Acros Organics	AC154980500	https://www.fishersci.com/shop/products/dehydroisoandrosterone-99-acros-organics/AC154980500
Alfa Chemistry	53-43-0	https://www.alfa-chemistry.com/dehydroepiandrosterone-cas-53-43-0-item-79560.htm
Alsachim	3710	http://www.alsachim.com/product-C5001-glo.bal-view.html
Ansion Pharma	53-43-0	http://www.ansionpharma.com/English/Product/0974815742.html
ApexBio Technology	B1375	http://www.apexbt.com/dehydroepiandrosterone-dhea.html
Aurora Fine Chemicals LLC	A17.877.349	http://online.aurorafinechemicals.com/info?ID=A17.877.349
Aurum Pharmatech LLC	M-1336	http://www.Aurumpharmatech.com/Product/ProductDetails/M_1336
AvaChem Scientific	3973	http://www.avachem.com/productSearch.asp?3973
BioChemPartner	BCP02453	http://www.biochempartner.com/53-43-0-BCP02453
BioSynth	D-0340	https://www.biosynth.com/en/products/life-science/other-biochemicals/products/D-0340.html
Chem Scene	CS-1667	http://www.chemscene.com/53-43-0.html
ChemFaces	CFN90043	http://www.chemfaces.com/natural/Dehydroepiandrosterone-CFN90043.html
ChemMol	30100413	http://www.chemmol.com/chemmol/30100413.html
Chemspace	CSSS00000029485	https://chem-space.com/CSSS00000029485
DC Chemicals	DC5201	http://www.dcchemicals.com/product_show-Dehydroepiandrosterone_DHEA_.html
Enamine	Z2213891300	https://www.enaminestore.com/catalog/Z2213891300
Glentham Life Sciences	GP0612	http://www.glentham.com/products/product/GP0612/
LGC Standards	DRE-C16286250	https://www.lgcstandards.com/US/en/p/DRE-C16286250
LGC Standards	LGCAMP0651.00-11	https://www.lgcstandards.com/US/en/p/LGCAMP0651.00-11
LGC Standards	LGCFOR0651.00	https://www.lgcstandards.com/US/en/p/LGCFOR0651.00
LGC Standards	MM0651.00-0250	https://www.lgcstandards.com/US/en/p/MM0651.00-0250
Matrix Scientific	89314	https://www.matrixscientific.com/089314.html
MedChem Express	HY-14650	https://www.medchemexpress.com/DHEA.html
MuseChem	A000700	https://www.musechem.com/product/A000700.html
Octagon Chemicals	API Dehydroepiandrosterone 53-43-0	https://octagonchem.com/
Parchem	18496	http://www.parchem.com/chemical-supplier-distributor/DHEA-008496.aspx
Parchem	10897	http://www.parchem.com/chemical-supplier-distributor/Dehydroepiandrosterone-000897.aspx
Sigma-Aldrich	D-063_CERILLIAN	https://www.sigmaaldrich.com/catalog/product/cerillian/d063?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sigma-Aldrich	D4000_SIGMA	https://www.sigmaaldrich.com/catalog/product/sigma/d4000?utm_source=pubchem&utm_campaign=pubchem_2017&utm_medium=referral
Sinfoo Biotech	S048429	http://www.sinfoobiotech.com/product/1051827
Smolecule	S525573	http://www.smolecule.com/products/s525573
THE BioTek	bt-266623	https://www.thebiotek.com/product/inhibitors/bt-266623
VladaChem	VL162585	https://www.vladachem.com/product.php?products=53-43-0
VladaChem	VL277861-1G	https://www.vladachem.com/product.php?products=53-43-0
W&J PharmaChem	100968	http://www.wjpharmachem.com/new/100968.html
eNovation Chemicals	K39145	https://www.enovationchem.com/ProductDetails.asp?ProductID=K39145
iChemical	EBD1328208	http://www.ichemical.com/products/53-43-0.html?utm_source=PubChem&utm_medium=website&utm_campaign=product%20catalogs

PubMed

Title	Date	PubMed
Intraadrenal mechanisms of DHEA regulation: a hypothesis for adrenopause.	2001	11341302
GG-genotype in the promotor region of uncoupling-protein-1 gene is associated with lower level of dehydroepiandrosterone in type 2 diabetes.	2001	11341297
Increased serum cortisol levels are associated with high tumour grade in patients with renal cell carcinoma.	2001	11321667
Effects of transdermal application of 7-oxo-DHEA on the levels of steroid hormones, gonadotropins and lipids in healthy men.	2001	11300231
Hyposecretion of the adrenal androgen dehydroepiandrosterone sulfate and its relation to clinical variables in inflammatory arthritis.	2001	11299059
Therapeutic strategies in adrenal insufficiency.	2001 Apr	11353897
Sex hormones and their impact on dementia and depression: a clinical perspective.	2001 Apr	11336603
[Correlations between acne and polycystic ovary. A study of 60 cases].	2001 Apr	11319503
Unsulfated and sulfated neurosteroids differentially modulate the binding characteristics of various radioligands of GABA(A) receptors following chronic ethanol administration.	2001 Apr	11311894
High-grade prostate cancer is associated with low serum testosterone levels.	2001 Apr	11304729
Up-regulation of cyclooxygenase-1 in neuroblastoma cell lines by retinoic acid and corticosteroids.	2001 Apr	11299304
Novel assay for determination of androgen bioactivity in human serum.	2001 Apr	11297580
Effect of estrogen on serum DHEA in younger and older women and the relationship of DHEA to adiposity and gender.	2001 Apr	11288048
Sarcopenia.	2001 Apr	11283518
Age-related changes of the hypothalamic-pituitary-adrenal axis: pathophysiological correlates.	2001 Apr	11275940
Leuprolide acetate treatment of adrenocortical disease in ferrets.	2001 Apr 15	11330611
cyp7b1 catalyses the 7alpha-hydroxylation of dehydroepiandrosterone and 25-hydroxycholesterol in rat prostate.	2001 Apr 15	11284740
Solvent and solid-phase extraction of natural and synthetic anabolic steroids in human urine.	2001 Apr 25	11339285
Expression and localization of cytochrome P450 17 alpha-hydroxylase/c17,20-lyase in the avian brain.	2001 Apr 27	11311872
DHEA: a novel adjunct for the treatment of male trauma patients.	2001 Feb	11286760
Dehydroepiandrosterone decreases mortality rate and improves cellular immune function during polymicrobial sepsis.	2001 Feb	11246320
[Aging without becoming old. 2 anti-aging days per week].	2001 Feb 15	11268750
Non-aqueous emulsions: hydrocarbon-formamide systems.	2001 Feb 19	11282235
Enhanced induction of the IgA response in pigs by calcitriol after intramuscular immunization.	2001 Feb 28	11228356
[Replacement therapy in adrenopause. Dehydroepiandrosterone and aging].	2001 Jan	11260976
Characteristics of cystic breast disease with special regard to breast cancer development.	2001 Jan-Feb	11299838
Ergosteroids IV: synthesis and biological activity of steroid glucuronosides, ethers, and alkylcarbonates.	2001 Jul	11322966
Neurosteroid hydroxylase CYP7B: vivid reporter activity in dentate gyrus of gene-targeted mice and abolition of a widespread pathway of steroid and oxysterol hydroxylation.	2001 Jun 29	11290741
Circulating plasma leptin and IGF-1 levels in girls with premature adrenarche: potential implications of a preliminary study.	2001 Mar	11355746
Exploratory biochemical data analysis: a comparison of two sample means and diagnostic displays.	2001 Mar	11350023
Assessment of endocrine status in patients undergoing in-vitro fertilization treatment. Is it necessary?	2001 Mar	11327087
Sex hormone-binding globulin as a marker of the effect of hormonal treatment in Turner's syndrome.	2001 Mar	11308992
Peroxisomal proliferator-activated ligand therapy for HIV lipodystrophy.	2001 Mar	11298105
Follicle-stimulating hormone regulates steroidogenic enzymes in cultured cells of the chick embryo ovary.	2001 Mar	11254372
Ergogenic aids: counseling the athlete.	2001 Mar 1	11261867
Ontogeny of the neurosteroid enzyme Cyp7b in the mouse.	2001 Mar 28	11306180
Temporal and spatial distribution of corticosteroidogenic enzymes immunoreactivity in developing human adrenal.	2001 Mar 28	11306177
Effect of beta-estradiol on voltage-gated Ca(2+) channels in rat hippocampal neurons: a comparison with dehydroepiandrosterone.	2001 Mar 30	11290370
Hormones as antiaging remedies.	2001 Mar-Apr	11326221
Adrenal steroids in human prostatic cancer cell lines.	2001 Mar-Apr	11297065
Sebocytes are the key regulators of androgen homeostasis in human skin.	2001 May	11348472
Dehydroepiandrosterone replacement in women with adrenal insufficiency: effects on body composition, serum leptin, bone turnover, and exercise capacity.	2001 May	11344193
Dehydroepiandrosterone inhibits lipopolysaccharide-induced nitric oxide production in BV-2 microglia.	2001 May	11331412
Identification and characterization of human organic anion transporter 3 expressing predominantly in the kidney.	2001 May	11306713
Influence of culture system and medium enrichment on sulfotransferase and sulfatase expression in male rat hepatocyte cultures.	2001 May 1	11301044
Dehydroepiandrosterone restores hepatocellular function and prevents liver damage in estrogen-deficient females following trauma and hemorrhage.	2001 May 15	11341799
Metabolism of DHEA by cytochromes P450 in rat and human liver microsomal fractions.	2001 May 15	11339818
Human oestrogenic 17beta-hydroxysteroid dehydrogenase specificity: enzyme regulation through an NADPH-dependent substrate inhibition towards the highly specific oestrone reduction.	2001 May 15	11336660
Serum hormones and the alcohol-breast cancer association in postmenopausal women.	2001 May 2	11333294
Anorectic effect of dehydroepiandrosterone combined with dexfenfluramine or thionisoxetine.	2001 May 4	11348631

Patents

Sample Use Guides

In Vivo Use Guide

Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator.

Route of Administration: Vaginal

In Vitro Use Guide

Dehydroepiandrosterone (DHEA) bound to AR with a Ki of 1 microM, which was associated with AR transcriptional antagonism on both the mouse mammary tumor virus and prostate-specific antigen promoters. DHEA bound to ERalpha and ERbeta, with Ki values of 1.1 and 0.5 microM, respectively. Despite the similar binding affinities, DHEA showed preferential agonism of ERbeta with an EC50 of approximately 200 nm and maximal activation at 1 microM. With ERalpha 30-70% agonism at 5 microM was found.

Substance Class	Chemical Created by `admin` on `Wed Jul 05 22:54:59 UTC 2023` Edited by `admin` on `Wed Jul 05 22:54:59 UTC 2023`
Record UNII	57B09Q7FJR
Record Status	`Validated (UNII)`
Record Version

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Name

Type

Language

PRASTERONE SULFATE

Common Name

English

ANDROST-5-EN-17-ONE, 3-(SULFOOXY)-, (3.BETA.)-

Systematic Name

English

Prasterone sulfate [WHO-DD]

Common Name

English

PRASTERONE SULPHATE

Common Name

English

DEHYDROEPIANDROSTERONE SULFATE

Common Name

English

GENAFLOW

Brand Name

English

PRASTERONE SULFATE [MART.]

Common Name

English

ANDROST-5-EN-17-ONE, 3.BETA.-HYDROXY-, HYDROGEN SULFATE

Systematic Name

English

DEHYDROANDROSTERONE SULFATE

Common Name

English

DEHYDROEPIANDROSTERONE SULFATE [MI]

Common Name

English

DHEA SULFATE

Common Name

English

Classification Tree Code System Code

CFR

21 CFR 862.1245